Clinical trial NCT03285490
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis Keratosis Keratosis, Actinic Precancerous Conditions Neoplasms Sun Damaged Skin Actinic Keratoses
Sponsor: Almirall, S.A.
Start date: 2017-09-15; Completion date: 2019-04-24
Enrollment: 351 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase III study was designed to evaluate the efficacy and safety of KX2-391 Ointment 1% in adult participants when applied to an area of skin containing 4-8 stable, clinically typical actinic keratosis (AK) lesions on the face or scalp.

Detailed description:
This study was a double-blinded, multicenter, efficacy, and safety study of KX2-391 ointment administered topically to the face or scalp of participants with AK.

The study consisted of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible participants received up to 5 consecutive days of topical treatment. Efficacy (lesion counts) and safety evaluations were performed.

Arms: arm 1: KX2-391 Ointment was applied once daily for 5 consecutive days on the face or scalp. arm 2: The Vehicle Ointment was applied once daily for 5 consecutive days on the face or scalp.
Interventions: intervention 1: KX2-391 Ointment 1% intervention 2: Placebo
Intervention descriptions: intervention 1: Dose: 1% (250 mg single-use packets); Dosage form: Ointment; Route of administration: Topical intervention 2: Dosage form: Ointment; Route of administration: Topical

Protocol documents:
Prot_000.pdf: 
Clinical Study Protocol_Amendment 01 
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REVISION HISTORY 
Revisions to Version 1.0 (Original Protocol) 
Current Version and Date:  v2.0_18 Feb 2018 (Amendment 01) 
Change 
Rationale 
Affected Protocol Sections 
Revised lesion count wording during the 
Recurrence Follow-up Period to indicate 
that lesions ‘within the treatment area’ 
should be counted.  Previously it was 
stated that lesions counted must be 
completely in the treatment area. 
To address concern 
regarding possible 
underestimation of 
recurrence. 
x 
Section 7.5.1 
Deleted reference to analysis of 
treatment/location interaction to show 
concordance. 
To provide clarification; 
the face and scalp will be 
analyzed as a whole; the 
face and scalp will also be 
analyzed separately to 
show consistency as to 
treatment location. 
x 
Synopsis/Efficacy Analyses 
x 
Section 9.1.6.1 
Provided language about pooling sites and 
additional analysis for site-to-site 
variability. 
To address potential 
variability among sites. 
x 
Synopsis/Efficacy Analyses 
x 
Section 9.1.6.1 
Provided additional language about how 
recurrence rates will be analyzed. 
Clarification of analysis for 
recurrence rate. 
x 
Synopsis/Efficacy Analyses 
x 
Section 9.1.6.2 
Added language for partial response rate 
analysis. 
To address multiplicity 
issues for the secondary 
efficacy endpoint. 
x 
Synopsis/Efficacy Analyses 
x 
Section 9.1.6.2 
Revised subsection numbering for 
additional AK lesion count analysis. 
Editorial. 
x 
Section 9.1.6.3 
Revised language regarding missing data 
handling/sensitivity and subgroup 
analyses. 
Clarification for these 
efficacy analyses. 
x 
Section 9.1.6.4 
x 
Section 9.1.6.5 
Deleted reduction in AK lesion count 
during Days 1-57 as a secondary 
objective/endpoint. 
To limit the number of 
secondary 
objectives/endpoints being 
measured in the study. 
x 
Synopsis 
- Secondary Objectives 
- Secondary Endpoints 
x 
Section 3.2 
x 
Section 9.1.1.1.2 
A urine pregnancy test, not a serum 
pregnancy test, will be conducted at 
Day 57/early termination visit, at the 
clinical site; pregnancy testing will be for 
women of childbearing potential. 
 
 
 
 
Modification and 
clarification of pregnancy 
testing procedures. 
x 
Table 1 
x 
Section 7.3.5 


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Change 
Rationale 
Affected Protocol Sections 
Standardized photography will be 
conducted at additional follow-up visits 
after Day 57 for subjects who have 
unresolved LSRs, hypo- or hyper-
pigmentation, or scarring in the treatment 
area. 
Clarification. 
x 
Synopsis 
- Study Design 
- LSR assessments 
x 
Table 1/footnote b 
x 
Section 4.1 
x 
Section 4.4 
x 
Section 7.3.4.5 
x 
Section 7.4 
The complete physical examination at 
Screening will not include an assessment 
of the integumentary system, as that will 
be part of the expanded dermatological 
examination. 
Clarification. 
x 
Table 1/footnote g 
x 
Section 7.1.9 
Information on study drug, label 
information, study kit dispensing, drug 
accountability, documentation, and 
instructions for requesting unblinding for 
medical emergencies or serious adverse 
events will be provided in a Pharmacy 
Manual, not a Clinical Operation Manual. 
Clarification. 
x 
Section 6.1.1 
x 
Section 6.3 
x 
Section 6.5.1 
x 
Section 8.2.5 
Medical history pertaining to actinic 
keratosis will include:  
x 
The initial diagnosis date of AK on 
the face or scalp, depending on the 
selection of the treatment area for the 
study 
x 
An AK treatment history of the face 
or scalp including all commercial and 
investigational products and surgical 
modalities dating back to the initial 
diagnosis. 
Clarification. 
x 
Section 6.4.1 
x 
Section 7.1.4 
Revised/reorganized the description of 
study endpoints. 
Clarification. 
x 
Synopsis/Statistical 
Methods/Endpoints 
x 
Section 3.2 
x 
Section 9.1.1 


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TITLE PAGE 
 
Clinical Study Protocol 
Study Protocol 
Number: 
KX01-AK-004 
Study Protocol 
Title: 
A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel 
Group, Multicenter, Efficacy and Safety Study of KX2-391 Ointment 
1% in Adult Subjects with Actinic Keratosis on the Face or Scalp  
Sponsor: 
Athenex, Inc.  
20 Commerce Drive 
Cranford NJ 07016, USA 
Tel:  908-340-6996 
 
Investigational 
Product Name: 
KX2-391 Ointment 1% 
Indication: 
Actinic keratosis on face or scalp 
Phase: 
3  
Approval Date:  
v1.0 
v2.0 
29 Jun 2017 (original protocol) 
18 Feb 2018 (Amendment 01) 
IND Number: 
122464 
UTN Number:
U1111-1191-8287  
GCP Statement: 
This study is to be performed in full compliance with International 
Council 
for 
Harmonisation 
of 
Technical 
Requirements 
for 
Registration of Pharmaceuticals for Human Use (ICH) and all 
applicable local Good Clinical Practice (GCP) and regulations.  All 
required study documentation will be archived as required by 
regulatory authorities. 
Confidentiality 
Statement: 
This document is confidential.  It contains proprietary information of 
Athenex, Inc. (the Sponsor).  Any viewing or disclosure of such 
information that is not authorized in writing by the Sponsor is strictly 
prohibited.  Such information may be used solely for the purpose of 
reviewing or performing this study. 


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CLINICAL PROTOCOL SYNOPSIS 
Compound No.:  KX2-391 
Name of Active Ingredient:  N-benzyl-2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl) acetamide 
Study Protocol Title 
A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy 
and Safety Study of KX2-391 Ointment 1% in Adult Subjects with Actinic Keratosis on the Face or 
Scalp 
Sites 
Approximately 25 to 40 sites in the United States 
Study Period and Phase of Development 
First subject in to last subject out, approximately 20 months 
Phase 3 
Study Hypothesis 
Treatment with KX2-391 Ointment 1% topical once daily for 5 consecutive days will demonstrate a 
greater complete clearance (defined as 100% clearance of clinically typical and visible actinic 
keratosis [AK] lesions at Day 57) than vehicle ointment once daily for 5 consecutive days in adults 
with AK on the face or scalp. 
Objectives  
Primary Objective 
x 
To evaluate the efficacy of topical KX2-391 Ointment 1% once daily for 5 consecutive days 
compared to vehicle control in terms of 100% clearance at Day 57 in the treatment of adults 
with AK, when applied to a contiguous area of 25 cm2 on the face or scalp 
Secondary Objectives 
x 
To evaluate the safety of topical KX2-391 Ointment 1% once daily for 5 consecutive days in 
terms of local skin reactions (LSRs) and other safety evaluations such as adverse events 
(AEs) and laboratory assessments 
x 
To compare the rates of pDUWLDOUHVSRQGHUVGHILQHGDV75% clearance of AK lesions in the 
treatment area on the face or scalp at Day 57 between the KX2-391 Ointment 1%-treated 
group and vehicle-treated group  
x 
To determine the recurrence of AK in the treatment area up to 12 months post-Day 57 in 
subjects who had complete clearance at Day 57 after 5 consecutive days of treatment with 
KX2-391 Ointment 1%  
x 
To evaluate the safety of topical KX2-391 Ointment 1% within the treatment area during the 
Recurrence Follow-up Period 
Study Design 
This is a double-blind, vehicle-controlled, randomized, parallel group, multicenter study to evaluate 
the efficacy and safety of KX2-391 Ointment 1% administered topically on the face or scalp of adult 
subjects with AK. 
Enrollment will be controlled so that approximately two thirds of subjects enrolled will be treated on 
the face and approximately one third of subjects enrolled will be treated on the scalp. 


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The study consists of Screening, Treatment, Response Assessment Period, and a Recurrence Follow-
up Period.  After a Screening Period of up to 28 days, subjects will return to the site for confirmation 
of eligibility.  Eligible subjects will be randomized on Day 1 to treatment in a 1:1 (KX2-391 
Ointment 1% or vehicle) ratio in each treatment area subgroup. 
The treatment area will be marked with indelible marker at Baseline (Day 1 predose) at the 
investigational site.  Subjects will be given verbal and written instructions on self-administration of 
study drug/vehicle and a study kit containing 5 daily single-dose packets, 1 for each day of treatment.  
The first dose will be applied by the subject under the supervision of study site personnel.  Subjects 
will then take home the study kit containing the remaining single-dose packets of study drug for daily 
self-administration on the next 4 consecutive days. 
Subjects will return to the clinical sites for assessments at the Response Assessment Visits on Days 5, 
8, 15, 29, and 57.   
All subjects who have unresolved LSRs, hypo- or hyper- pigmentation, scarring in the treatment area, 
or treatment-related AEs at Day 57 will return for additional follow-up, which includes standardized 
photography of the treatment area, every 7 to 28 days until resolution, returned to baseline, or deemed 
stabilized by the Investigators. 
Subjects who achieve 100% clearance of AK lesions in the treatment area at Day 57 will continue in 
the Recurrence Follow-up Period to determine recurrence rate and safety for up to 12 months 
following the Day 57 Visit.  Visits during the Recurrence Follow-up Period will occur every 
3 months.  Subjects who develop AK lesions in the treatment area during the Recurrence Follow-up 
Period will be discontinued at the time of recurrence. 
Number of Subjects 
A sufficient number of subjects will be screened to randomize approximately 300 subjects.  At each 
site, a minimum of 10 subjects and a maximum of 20 subjects are projected to be enrolled. 
Inclusion Criteria 
1. 0DOHVDQGIHPDOHV\HDUVROG 
2. A treatment area on the face or scalp that: 
x 
is a contiguous area measuring 25 cm2 
x 
contains 4 to 8 clinically typical, visible, and discrete AK lesions  
3. Subjects who in the judgment of the Investigator, are in good general health based on: 
x 
medical history 
x 
physical examination (PE) findings 
x 
vital signs  
x 
electrocardiogram (ECG), clinical chemistry, hematology, and urinalysis results  
4. Females must be postmenopausal (>45 years of age with at least 12 months of amenorrhea), 
surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, if of 
childbearing potential, must be using highly effective contraception for at least 30 days or 
1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use 
highly effective contraception for at least 30 days following their last dose of study treatment.  
Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive 
implant, injection or patch, intrauterine device or complete abstinence from sexual intercourse.  
5. Sexually active males who have not had a vasectomy, and whose partner is reproductively 
capable, must agree to use barrier contraception from Screening through 90 days after their last 
dose of study treatment. 


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6. All subjects must agree not to donate sperm or eggs or attempt conception from Screening 
through 90 days following their last dose of study treatment. 
7. Females of childbearing potential must have a negative serum pregnancy test at Screening and a 
negative urine pregnancy test on Day 1 prior to randomization. 
8. Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of 
tanning beds, to the face or scalp  
9. Able to comprehend and are willing to sign the informed consent form (ICF). 
Exclusion Criteria 
1. Clinically atypical and/or rapidly changing AK lesions on the treatment area, eg, hypertrophic, 
hyperkeratotic, recalcitrant disease (had cryosurgery on two previous occasions) and/or cutaneous 
horn 
2. Location of the treatment area is: 
x 
On any location other than the face or scalp 
x 
Within 5 cm of an incompletely healed wound 
x 
Within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) 
3. Been previously treated with KX2-391 Ointment 
4. Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57 
5. Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic 
therapy, or other treatments for AK within the treatment area or within 2 cm of the treatment 
area, within 8 weeks prior to the Screening visit 
6. Use of the following therapies and/or medications within 2 weeks prior to the Screening visit: 
x 
Cosmetic or therapeutic procedures (eg, use of liquid nitrogen, surgical excision, curettage, 
dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment 
area or within 2 cm of the selected treatment area 
x 
Acid-containing therapeutic products (eg, salicylic acid or fruit acids, such as alpha- and 
beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the 
treatment area or within 2 cm of the selected treatment area  
x 
Topical salves (non-medicated/non-irritant lotion and cream are acceptable) or topical 
steroids within the treatment area or within 2 cm of the selected treatment area; artificial 
tanners within the treatment area or within 5 cm of the selected treatment area 
7. Use of the following therapies and/or medications within 4 weeks prior to the Screening visit:  
x 
Treatment 
with 
immunomodulators 
(eg, 
azathioprine), 
cytotoxic 
drugs 
(eg, 
cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/interferon 
inducers 
x 
Treatment with systemic medications that suppress the immune system (eg, cyclosporine, 
prednisone, methotrexate, alefacept, infliximab) 
8. Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the 
Screening visit 
9. A history of sensitivity and/or allergy to any of the ingredients in the study medication 
10. A skin disease (eg, atopic dermatitis, psoriasis, eczema) or condition (eg, scarring, open wounds) 
that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or 
which exposes the subject to unacceptable risk by study participation 


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11. Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of 
the Investigator, would expose the subject to unacceptable risk by study participation 
12. Females who are pregnant or nursing 
13. Participated in an investigational drug trial during which an investigational study medication was 
administered within 30 days or 5 half-lives of the investigational product, whichever is longer, 
before dosing 
Study Treatments 
KX2-391 Ointment 1% or vehicle ointment will be applied topically once daily for 5 consecutive 
days. 
Duration of Study 
For the Screening, Treatment, and Response Assessment Periods, each subject will participate for up 
to 85 days: screening up to 28 days prior to Day 1, treatment for 5 consecutive days, and follow-up 
until Day 57.  The Recurrence Follow-up Period will be for up to 12 months post-Day 57.  Thus, the 
maximum overall duration of participation for each subject is approximately 15 months. 
Concomitant Drug/Therapy 
Use of any treatment for AK lesions other than study drug on the treatment area is prohibited during 
the study. 
Assessments during the Treatment and Response Assessment Periods (Day 1 through Day 57) 
Efficacy Assessments  
A dermatologist (Investigator or Subinvestigator) will perform a count of clinically visible AK lesions 
(lesion count) for all subjects at Screening, Baseline (Day 1 predose), and at the Response Assessment 
Visits on Days 8, 15, 29, and 57. 
Safety Assessments 
Safety will be assessed periodically through Day 57 by recording AEs, serious adverse events 
(SAEs), LSRs, and events of special interest. 
Safety assessments will also include vital signs, the performance of PEs, ECGs, laboratory evaluation 
of hematology, biochemistry, and urinalyses, and evaluation of pigmentation and scarring in the 
treatment area at prespecified timepoints (Table 1, Schedule of Procedures and Assessments). 
At each study visit, subjects will be asked a general question “How have you been since the last 
visit?”.  Adverse events will be recorded at each study visit, before assessment of LSRs, 
pigmentation, and scarring in the treatment area.  AEs will be reported separately from LSRs. 
LSR Assessments 
The LSR assessment is the Investigator’s (or Subinvestigator’s) assessment of the following signs on the 
treatment area:  erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and 
erosion/ulceration.  These signs will be assessed using a grading scale ranging from 0=absent, 1=mild 
(slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense).  
In addition to LSRs, hypo- and hyper- pigmentation and scarring on the treatment area will be 
assessed as being present or absent.  Application site reactions not classified as LSRs (eg, itching, 
burning, stinging, tenderness, pain) will be reported as AEs.  Standardized photography will be 
performed on Day 1 prior to dosing, and on Days 5, 8, 15, 29, and 57, and at additional follow-up 
visits for subjects who have unresolved LSRs, hypo- or hyper- pigmentation, or scarring in the 
treatment area. 
 
 


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Events of Special Interest 
x 
Overdose of study medication 
x 
Pregnancy  
x 
Ocular exposures to study medication 
x 
Skin cancers (including BCC, SCC, and melanoma); the location and treatment will be 
reported. 
Assessments during the Recurrence Follow-up Period (up to 12 months post-Day 57) 
Efficacy Assessments  
A dermatologist (Investigator or Subinvestigator) will perform a count of clinically visible AK 
lesions (lesion count) for subjects who achieve 100% clearance of AK lesions in the treatment area at 
Day 57 during the Recurrence Follow-up Period at the 3-, 6-, 9- and 12-month visits.  
Safety Assessments 
During the Recurrence Follow-up Period, safety assessments will include the monitoring and 
recording of AEs and SAEs within the treatment area at the 3-, 6-, 9- and 12-month visits.   
Events of Special Interest 
x 
Skin cancers (including BCC, SCC, and melanoma) within the treatment area 
x 
Pregnancy 
Statistical Methods 
Efficacy: 
Primary Endpoint 
x 
Complete (100%) clearance rate of AK lesions, defined as the proportion of subjects at 
Day 57 with no clinically visible AK lesions in the treatment area 
Secondary Endpoints 
Key Secondary Endpoint: 
x 
Partial clearance rate of AK lesions, defined as the proportion of subjects at Day 57 with a 
75% reduction in the number of AK lesions identified at Baseline (Day 1 predose) in the 
treatment area 
Additional Endpoint: 
x 
Recurrence rate of AK lesions in subjects who achieved complete clearance at Day 57 
Safety: 
x 
Evaluation of LSRs, pigmentation and scarring in the treatment area, AEs, SAEs, events of 
special interest, clinical laboratory data, and other safety assessments (vital signs, PEs, 
ECGs) 
x 
AEs within the treatment area after Day 57 and up to 12 months post-Day 57 
Analysis Populations 
Intent-To-Treat (ITT) Population: all randomized subjects. This is the primary efficacy population.  
Per-Protocol (PP)/Evaluable Population:  all randomized subjects who have received at least 4 of 
the 5 doses, conformed to the protocol as to entry criteria, did not receive concomitant medications 
that can affect efficacy, and returned for the final visit on Day 57.  
Safety Population:  all randomized subjects who have received at least one dose of study treatment. 
 


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Recurrence Follow-up Population:  all subjects who achieved complete clearance at Day 57, 
regardless of which treatment they received. 
Efficacy Analyses 
To achieve statistical significance in the study, the Day 57 complete clearance rate will be analyzed 
using a Cochran-Mantel-Haenszel (CMH) model controlling for treatment location and treatment 
group.  Before applying the CMH method, a Breslow-Day test with a significance level of 10% will 
be used to explore heterogeneity of the odds ratios across treatment location subgroups. 
Further, the Pearson Chi Square (used to power the study) will be applied to demonstrate basic 
agreement with the CMH. 
The primary efficacy analysis will be performed with the ITT population, and will be repeated with 
the PP/Evaluable population to support the primary efficacy analysis results. 
Low enrollment sites will be pooled to analysis sites with approximately 20 subjects in each pool. For 
example, the number of subjects enrolled will be graphically displayed by study site and treatment 
location (face or scalp) from the smallest number to the largest, with bars depicting treatment 
response. Then, analysis sites will be defined for approximately every 20 subjects pooled from the 
study sites with the lowest enrollment. 
Another CMH test adjusting for treatment group and analysis site will be performed to ensure 
concordance with the primary efficacy endpoint analyses described above. 
To explore heterogeneity of the odds ratios across analysis sites, the Breslow-Day test at a 
significance level of 10% will be applied. A finding of statistical significance in this test will be 
followed by exploratory analyses to identify outlier study sites. The outlier sites will be discussed and 
an exploratory analysis excluding the outlier sites may be carried out to estimate the impact of site-
by-treatment interactions. This process will be documented as an appendix to the final version of the 
SAP, prior to the first database lock. 
Partial clearance rate will be analyzed in the same way as the primary efficacy endpoint (complete 
clearance rate).  However, to control for multiplicity, partial clearance rate as the key secondary 
efficacy endpoint will be examined using a step-down gatekeeping testing strategy for the overall 
type I error rate. In other words, the primary endpoint will serve as a gatekeeper for the key 
secondary endpoint. The complete clearance rate will be tested initially; if, and only if it is 
statistically significant at the 0.05 significance level, then the partial clearance rate will be statistically 
tested at the same significance level. 
Recurrence rates will be estimated based on a Kaplan-Meier method at each nominal post-Day 57 
visit.  Subjects with missing AK assessments in the Recurrence Follow-up Period will be considered 
as censored. 
Safety Analyses 
For AEs, verbatim terms on the electronic case report form (eCRF) will be mapped to preferred terms 
(PTs) and system organ classes (SOCs) using the Medical Dictionary for Regulatory Activities 
(MedDRA; v 16.0 or higher).   
Treatment-emergent adverse events (TEAEs) are defined as either those AEs with an onset after the 
first dose or those pre-existing AEs that worsen after the first dose.  The incidence of TEAEs will be 
summarized by treatment group.  TEAEs will also be summarized by severity and relationship to 
study treatment.  By-subject listings of all SAEs and events of special interest will be provided. 
Laboratory parameters will be summarized using descriptive statistics at baseline and at each 
subsequent timepoint by treatment group.  Changes from baseline will also be summarized by 
treatment group.  In addition, shift tables (ie, low-normal-high at baseline versus low-normal-high at 
follow-up in a 3-by-3 contingency table) will be provided to assess changes in laboratory values from 


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baseline to Day 8 and baseline to Day 15 in each treatment group. 
LSR, hyper- or hypo-pigmentation and scarring assessment results obtained through Day 57 will be 
displayed and summarized by visit and treatment group.   
Safety data collected through Day 57 and during the Recurrence Follow-up Period will be analyzed 
separately.  
Interim Analyses 
No interim analysis is planned for this study. 
Sample Size Rationale 
The sample size was estimated based on the primary efficacy endpoint for the comparison of 
KX2-391 Ointment 1% and vehicle control.  By using a Pearson Chi-square method, a sample size of 
100 scalp-treated subjects and 200 face-treated subjects, both of which are with a 1:1 treatment 
allocation ratio, will give a greater than 90% power to detect a 20% difference (30% for active 
treatment and 10% for vehicle control) with a two-tailed significant level 0.05. 
FINAL: v2.0_18 Feb 2018 
 


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SCHEDULE OF PROCEDURES AND ASSESSMENTS 
Table 1 
Schedule of Procedures and Assessments in KX01-AK-004 
 
Period 
Screening  
Treatment 
Response Assessment  
Recurrence Follow-upa 
Clinic Visit 
1 
2 
At home once-
daily self-
administration 
of treatment  
3 
4 
5 
6 
7 / 
Early 
Termb  
8, 9, 10, 11a 
Day 
-28 to -1 
1 
Baseline 
2-5 
5 
8 
15 
29 
57b 
3, 6, 9, 12 Months  
Post-Day 57c 
Visit time window (days) 
None 
None 
 
None 
±2 
±2 
±3 
±5 
±14 
Informed consent 
X 
 
 
 
 
 
 
 
 
Inclusion & exclusion criteria 
X 
Xd 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Medical/surgical history 
X 
 
 
 
 
 
 
 
 
AK history/AK treatment history 
X 
 
 
 
 
 
 
 
 
Prior and concomitant medications/therapies 
X 
Xd 
 
X 
X 
X 
X 
X 
X 
Fitzpatrick skin-type scale 
X 
 
 
 
 
 
 
 
 
Expanded dermatological exame 
X 
 
 
 
 
 
 
 
 
Treatment area identification 
X 
Xd,f 
 
 
 
 
 
  
 
AK lesion count in treatment area 
X 
Xd 
 
 
X 
X 
X 
X 
X 
Physical examination, including weight and 
heightg 
X 
 
 
 
 
 
 
X 
 
Vital signsh 
X 
Xd 
 
X 
 
 
 
X 
 
ECGi 
X 
Xd 
 
X 
 
X 
 
 
 
Clinical chemistry, hematology, and UA 
Xj 
 
 
 
X 
X 
 
 
 
Serum pregnancy test for WOCBP 
X 
 
 
 
X 
 
 
 
 
Urine pregnancy test for WOCBP 
 
Xk 
 
 
 
 
 
X 
 
AEsl 
X 
Xd 
 
X 
X 
X 
X 
X 
Xm 
Focused dermatological exam of treatment 
area 
 
Xd 
 
X 
X 
X 
X 
X 
 
 
LSRs 
 
Xd 
 
X 
X 
X 
X 
X 
 
 
Pigmentation and scarring 
 
Xd 
 
X 
X 
X 
X 
X 
 


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Table 1 
Schedule of Procedures and Assessments in KX01-AK-004 
 
Period 
Screening  
Treatment 
Response Assessment  
Recurrence Follow-upa 
Clinic Visit 
1 
2 
At home once-
daily self-
administration 
of treatment  
3 
4 
5 
6 
7 / 
Early 
Termb  
8, 9, 10, 11a 
Day 
-28 to -1 
1 
Baseline 
2-5 
5 
8 
15 
29 
57b 
3, 6, 9, 12 Months  
Post-Day 57c 
Standardized photography 
 
Xd 
 
X 
X 
X 
X 
X 
 
Randomization 
 
X 
 
 
 
 
 
 
 
Instructions for self-administration; 
dispense study medication  
 
Xd 
 
 
 
 
 
 
 
Study medication application 
 
X 
X 
 
 
 
 
 
 
Study drug / dosing log return 
 
 
 
Xn 
 
 
 
 
 
AE = adverse event; AK = actinic keratosis; ECG = electrocardiogram; HEENT = head, eyes, ears, nose, and throat; LSR = local skin reaction; Term = Termination; UA = 
urinalysis; WOCBP = women of child-bearing potential. 
a. 
For Day 57 complete responders only 
b. 
These are assessments to be completed by all subjects.  For those who do not have complete response at Day 57 or who are discontinued early from the study, this will be their 
final visit.  All subjects who have unresolved LSRs, hypo- or hyper-pigmentation, scarring in the treatment area, or treatment-related AEs at Day 57 will return for additional 
follow-up, which includes standardized photography of the treatment area, every 7 to 28 days until resolution, returned to baseline, or deemed stabilized by the Investigators. 
c. 
For subjects who have complete response at Day 57 and no recurrence, 12 months post-Day 57 is the Final Visit.  Those subjects who have AK recurrence in the treatment 
area will have their final assessments at the visit when the AK recurrence is identified.  
d. 
These are baseline procedures/assessments and will be performed before randomization. 
e. 
An expanded dermatological examination to cover the sun-exposed areas where photo-damage is likely will be conducted at Screening only. 
f. 
The location and shape of the treatment area will be marked on an acetate transparency sheet for recording purposes and on the subject’s skin for identification of the 
treatment area for daily self-administration of study ointment. 
g. 
A complete PE will include weight and an assessment of HEENT, integumentary (Day 57 only), gastrointestinal, cardiovascular, respiratory, musculoskeletal, and 
neurological systems.  Height will be measured at Screening only.  This will be considered the baseline assessment. 
h. 
Vital signs measurements will be taken after the subject has been seated for at least 5 minutes. 
i. 
Subjects must be in the recumbent position for a period of 5 minutes prior to the ECG.  Baseline ECG is performed predose.  
j. 
This will be considered the baseline assessment. 
k. 
For females of childbearing potential: urine pregnancy test on Day 1 before randomization. 
l. 
At each study visit, subjects will be asked a general question “How have you been since the last visit?”.  AEs will be recorded before assessment of LSRs, pigmentation, and 
scarring in the treatment area.  AEs will be reported separately from LSRs.   
m. Only AEs in the treatment area will be collected. 
n. 
On Day 5 (Visit 3), subjects are to come into the clinic after study treatment is self-administered.  Subjects are to bring all 5 study drug packets (used and unused) in the study 
kit and the dosing log back to the site. 


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TABLE OF CONTENTS 
REVISION HISTORY...............................................................................................................1 
TITLE PAGE .............................................................................................................................3 
CLINICAL PROTOCOL SYNOPSIS .......................................................................................4 
SCHEDULE OF PROCEDURES AND ASSESSMENTS .....................................................11 
TABLE OF CONTENTS .........................................................................................................13 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ..........................................18 
1 
INVESTIGATORS AND STUDY PERSONNEL ..........................................................19 
2 
INTRODUCTION ...........................................................................................................19 
2.1 
Background ............................................................................................................19 
2.1.1 
Indication .....................................................................................................19 
2.1.2 
Mechanism of Action ...................................................................................19 
2.1.3 
Nonclinical Studies ......................................................................................19 
2.1.4 
Clinical Experience with KX2-391 ..............................................................21 
2.1.4.1 
KX2-391 in Cancer (Oral) ...................................................................21 
2.1.4.2 
KX2-391 as a Topical Treatment for Actinic Keratosis ......................21 
2.2 
Study Rationale ......................................................................................................22 
2.3 
Potential Risks and Benefits ..................................................................................22 
3 
STUDY OBJECTIVES AND ENDPOINTS ...................................................................23 
3.1 
Primary Objective and Endpoint ............................................................................23 
3.2 
Secondary Objectives and Endpoints.....................................................................23 
4 
INVESTIGATIONAL PLAN ..........................................................................................24 
4.1 
Overall Study Design and Plan ..............................................................................24 
4.2 
Screening Period ....................................................................................................25 
4.3 
Treatment Period ....................................................................................................25 
4.4 
Response Assessment Period .................................................................................26 
4.5 
Recurrence Follow-up Period ................................................................................26 
4.6 
Discussion of Study Design, Including Choice of Dosing and Control Groups ....26 
5 
STUDY POPULATION ..................................................................................................27 
5.1 
Inclusion Criteria ...................................................................................................27 
5.2 
Exclusion Criteria ..................................................................................................28 
5.3 
Subject Withdrawal / Discontinuation Criteria ......................................................29 
6 
STUDY TREATMENTS .................................................................................................30 
6.1 
Identity of Study Drugs ..........................................................................................30 
6.1.1 
Formulation, Packaging, and Labeling ........................................................30 
6.1.2 
Storage Conditions .......................................................................................31 
6.2 
Dosage and Administration of Study Drugs ..........................................................31 


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6.2.1 
Administration of Study Drugs ....................................................................31 
6.2.1.1 
Instructions in the Event of Ocular Exposure ......................................31 
6.2.2 
Criteria for Interruption of Treatment/Dose Adjustments ...........................32 
6.3 
Randomization/Method of Assigning Subjects to Treatment Groups ...................32 
6.3.1 
Blinding........................................................................................................32 
6.4 
Prior and Concomitant Medications / Therapy ......................................................33 
6.4.1 
Prior Medications / Therapy ........................................................................33 
6.4.2 
Concomitant Medications/Therapy ..............................................................33 
6.4.3 
Prohibited Medication/Therapy ...................................................................33 
6.4.4 
Other Prohibitions and Restrictions during Study .......................................34 
6.5 
Drug Accountability and Treatment Compliance ..................................................34 
6.5.1 
Drug Supplies and Accountability ...............................................................34 
6.5.2 
Treatment Compliance .................................................................................35 
7 
STUDY PROCEDURES AND ASSESSMENTS ...........................................................35 
7.1 
Screening Assessments ..........................................................................................35 
7.1.1 
Informed Consent.........................................................................................35 
7.1.2 
Inclusion/Exclusion Criteria ........................................................................35 
7.1.3 
Demography .................................................................................................36 
7.1.4 
Medical/Surgical and Actinic Keratosis History .........................................36 
7.1.5 
Prior Medications .........................................................................................36 
7.1.6 
Fitzpatrick Skin-Type Classification ...........................................................36 
7.1.7 
Expanded Dermatological Examination ......................................................36 
7.1.8 
Treatment Area Identification and AK Lesion Count Examination ............36 
7.1.9 
Physical Examinations .................................................................................37 
7.1.10 
Vital Signs ....................................................................................................37 
7.1.11 
Electrocardiograms ......................................................................................37 
7.1.12 
Laboratory Measurements ...........................................................................37 
7.1.13 
Pregnancy Testing ........................................................................................37 
7.2 
Baseline Assessments ............................................................................................37 
7.2.1 
Inclusion/Exclusion Criteria ........................................................................37 
7.2.2 
Prior Medications .........................................................................................38 
7.2.3 
Treatment Area Identification ......................................................................38 
7.2.4 
Actinic Keratosis Lesion Count ...................................................................38 
7.2.5 
Focused Dermatological Exam of Treatment Area .....................................38 
7.2.5.1 
Local Skin Reactions ...........................................................................39 
7.2.5.2 
Pigmentation and Scarring ...................................................................39 
7.2.6 
Standardized Photography ...........................................................................39 


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7.2.7 
Vital Signs ....................................................................................................39 
7.2.8 
Electrocardiograms ......................................................................................39 
7.2.9 
Pregnancy Testing ........................................................................................40 
7.2.10 
Randomization .............................................................................................40 
7.2.11 
Instructions for Self-administration of Study Treatment, Dispensing, 
and Return of Study Treatment ....................................................................40 
7.3 
Treatment Period and Response Assessment Period .............................................40 
7.3.1 
Treatment Administration – Days 1-5 .........................................................40 
7.3.2 
Efficacy Assessments...................................................................................40 
7.3.2.1 
Actinic Keratosis Lesion Count ...........................................................40 
7.3.3 
Pharmacokinetic, Pharmacodynamic, Pharmacogenomic, and Other 
Biomarker Assessments ...............................................................................41 
7.3.4 
Safety Assessments ......................................................................................41 
7.3.4.1 
Adverse Events ....................................................................................41 
7.3.4.1.1 
Assessing Severity of Adverse Events ...........................................43 
7.3.4.1.2 
Assessing Relationship to Study Treatment ..................................43 
7.3.4.2 
Serious Adverse Events .......................................................................44 
7.3.4.3 
Events of Special Interest.....................................................................44 
7.3.4.4 
Concomitant Medications ....................................................................45 
7.3.4.5 
Focused Dermatological Exam of Treatment Area and Standard 
Photography .........................................................................................45 
7.3.4.5.1 
Local Skin Reactions .....................................................................45 
7.3.4.5.2 
Pigmentation and Scarring .............................................................46 
7.3.4.6 
Physical Examinations .........................................................................46 
7.3.4.7 
Vital Signs ............................................................................................46 
7.3.4.8 
Electrocardiograms ..............................................................................46 
7.3.4.9 
Laboratory Measurements ...................................................................46 
7.3.5 
Pregnancy Testing ........................................................................................47 
7.4 
Additional Follow-up Assessments .......................................................................47 
7.5 
Recurrence Follow-up Period Assessments ...........................................................48 
7.5.1 
Recurrence Assessments ..............................................................................48 
7.5.2 
Safety Assessments ......................................................................................48 
7.6 
Appropriateness of Measurements .........................................................................49 
8 
EXPEDITED REPORTING ............................................................................................49 
8.1 
Reporting of Serious Adverse Events ....................................................................49 
8.2 
Reporting of Events of Special Interest .................................................................50 
8.2.1 
Pregnancy .....................................................................................................50 
8.2.2 
Study Drug Overdose ...................................................................................51 


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8.2.3 
Ocular Exposure...........................................................................................51 
8.2.4 
Skin Cancer ..................................................................................................51 
8.2.5 
Breaking the Blind .......................................................................................52 
9 
STATISTICAL METHODS ............................................................................................52 
9.1 
Statistical and Analytical Plans ..............................................................................52 
9.1.1 
Study Endpoints ...........................................................................................53 
9.1.1.1 
Efficacy ................................................................................................53 
9.1.1.1.1 
Primary Endpoint ...........................................................................53 
9.1.1.1.2 
Secondary Endpoints .....................................................................53 
9.1.1.2 
Safety ...................................................................................................53 
9.1.2 
Definitions of Analysis Sets.........................................................................53 
9.1.3 
Subject Disposition ......................................................................................54 
9.1.4 
Demographic and Other Baseline Characteristics .......................................54 
9.1.5 
Prior and Concomitant Therapy ...................................................................54 
9.1.6 
Efficacy Analyses ........................................................................................54 
9.1.6.1 
Primary Efficacy Endpoint Analysis ...................................................54 
9.1.6.2 
Secondary Efficacy Endpoint Analyses ...............................................55 
9.1.6.3 
Additional AK Lesion Count Analysis ................................................55 
9.1.6.4 
Missing Data Handling and Sensitivity Analysis ................................56 
9.1.6.5 
Subgroup Analysis ...............................................................................56 
9.1.7 
Safety Analyses ............................................................................................56 
9.1.7.1 
Extent of Exposure ...............................................................................56 
9.1.7.2 
Adverse Events ....................................................................................57 
9.1.7.3 
Laboratory Values ................................................................................57 
9.1.7.4 
Pregnancy Tests ...................................................................................58 
9.1.7.5 
Vital Signs ............................................................................................58 
9.1.7.6 
Electrocardiograms ..............................................................................58 
9.1.7.7 
Physical Examinations .........................................................................58 
9.1.7.8 
Local Skin Reactions and Pigmentation and Scarring .........................58 
9.1.8 
Determination of Sample Size .....................................................................58 
9.1.9 
Interim Analysis ...........................................................................................58 
9.1.10 
Other Statistical/Analytical Issues ...............................................................58 
9.1.11 
Procedure for Revising the Planned Analysis ..............................................59 
10 PROCEDURES AND INSTRUCTIONS ........................................................................60 
10.1 
Access to Source Data / Documents ......................................................................60 
10.2 
Quality Control and Quality Assurance .................................................................61 
10.2.1 
Data Collection ............................................................................................61 


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10.2.2 
Clinical Data Management ..........................................................................61 
10.3 
ETHICS..................................................................................................................61 
10.3.1 
Institutional Review Boards .........................................................................62 
10.3.2 
Subject Information and Informed Consent .................................................62 
10.4 
Data Handling and Recordkeeping ........................................................................63 
10.4.1 
Recording of Data ........................................................................................63 
10.4.2 
Identification of Source Data .......................................................................63 
10.4.3 
Retention of Records....................................................................................63 
10.5 
Publication Policy ..................................................................................................64 
10.6 
Other Administrative Policies ................................................................................64 
10.6.1 
Changes to the Protocol ...............................................................................64 
10.6.2 
Disclosure and Confidentiality ....................................................................64 
10.6.3 
Discontinuation of Study .............................................................................65 
11 REFERENCE LIST .........................................................................................................66 
12 APPENDICES .................................................................................................................67 
APPENDIX 1 
INSTRUCTIONS FOR SUBJECTS’ SELF-ADMINISTRATION OF 
STUDY TREATMENT ...................................................................................................68 
PROTOCOL SIGNATURE PAGES .......................................................................................70 
 
LIST OF IN-TEXT TABLES 
Table 1 
Schedule of Procedures and Assessments in KX01-AK-004 ....................11 
Table 2 
Treatments in KX01-AK-004 ....................................................................31 
Table 3 
Clinical Laboratory Tests ...........................................................................47 
 
LIST OF IN-TEXT FIGURES 
Figure 1 
Study Design for KX01-AK-004 ...............................................................25 
 
LIST OF APPENDICES 
Appendix 1 
Instructions for Subjects’ Self-administration of Study Treatment ...........68 
 


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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation 
Terms 
AE 
adverse event 
AK 
actinic keratosis 
BCC 
basal cell carcinoma 
CFR 
Code of Federal Regulations 
CMH 
Cochran-Mantel-Haenszel 
CRA 
clinical research associate 
CRO 
contract research organization 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
GCP 
Good Clinical Practice 
ICF 
informed consent form 
ICH 
International Council for Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use 
IRB 
Institutional Review Board 
ITT 
Intent-To-Treat 
LSR 
local skin reaction 
MedDRA 
Medical Dictionary for Regulatory Activities 
NOAEL 
no observed adverse effect level 
PE 
physical examination 
PP 
Per-Protocol 
PT 
preferred term 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SCC 
squamous cell carcinoma 
SD 
standard deviation 
SOC 
system organ class 
SOP 
standard operating procedure 
TEAE 
treatment-emergent adverse event 
US 
United States 
UV 
ultraviolet (light) 
 
 


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1 
INVESTIGATORS AND STUDY PERSONNEL 
This study will be conducted by qualified Investigators under the sponsorship of Athenex, 
Inc. (the Sponsor) at approximately 25 to 40 investigational sites in the United States (US). 
The name, telephone number, and email address of the Medical Monitor and other contact 
personnel at the Sponsor are listed in the Regulatory Binder provided to each site. 
2 
INTRODUCTION 
2.1 
Background 
2.1.1 
Indication 
In this study, the efficacy and safety of KX2-391 Ointment 1% will be evaluated in adult 
subjects with a diagnosis of clinically typical actinic keratosis (AK) on the face or scalp. 
2.1.2 
Mechanism of Action 
KX2-391 (referred to as KX01 in study protocol numbers) is a synthetic and highly selective 
inhibitor of Src tyrosine kinase signaling and tubulin polymerization.  KX2-391 Ointment is 
being developed as a topical treatment for AK.  KX2-391 is also being developed as an oral 
agent for oncology indications. 
KX2-391 promotes the induction of p53, G2/M arrest of proliferating cell populations and 
subsequent apoptosis via the stimulation of Caspase-3 and PARP cleavage.  Potent inhibition 
of the growth of primary human keratinocytes and several melanoma cell lines in vitro (50% 
growth inhibition [GI50 YDOXHV@Q0VXJJHVWVWKDW.;-391 has the potential to inhibit 
the proliferative expansion and promote apoptosis of abnormally proliferating cells in the 
epidermal and dermal layers upon topical application.  KX2-391 has also been observed to 
inhibit T cell migration and endothelial tubule formation in vitro, suggesting additional 
potential therapeutic benefits for conditions where pathology is supported by lymphocyte 
infiltration, inflammation, and/or angiogenesis. 
2.1.3 
Nonclinical Studies 
Details regarding KX2-391 nonclinical studies are provided in the KX2-391 Ointment 
Investigator’s Brochure. 
The bioavailability of KX2-391 after dermal administration to rats (1.59%) and rabbits 
(2.49% to 6.47%, depending on concentration) was low.  Plasma concentrations of KX2-391 
increased with repeat dermal administration, and in rats the plasma levels after 6 days dermal 
dosing reached or exceeded levels produced by oral administration of KX2-391 at the no 
observed adverse effect level (NOAEL) dose (1.25 mg/kg/dose) in a 28-day twice-daily oral 
toxicity study. Following 28 days of KX2-391 topical administration at increasing doses 


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(0.1%, 1%, and 2%) in rats and minipigs, an increase in KX2-391 plasma exposure was 
observed from Day 1 to Day 28, suggesting slight drug accumulation. 
In 28-day repeat-dose toxicology studies, KX2-391 ointment was administered to rats and 
minipigs at dose strengths 0.1%, 1%, and 2%. Ointment volumes of 2 mL/kg body weight 
were applied to approximately 10% of the body surface area of the skin. The administration 
sites were occluded with gauze and the applications left for 8 h/day in rats. The application 
site was semi-occluded for 20-22 hours in minipigs. These doses contained 2, 20, or 
40 mg/kg KX2-391, respectively, equivalent to 12, 120, or 240 mg/m2 in rats and 70, 700, or 
1400 mg/m2 in minipigs. Systemic exposures on Day 28 to KX2-391 following daily 
application of 0.1% ointment were Cmax 22.9 ng/mL (male)/33.7 ng/mL (female) and 
AUC0-24h 205 h*ng/mL (male)/216 h*ng/mL (female) in rats, and Cmax 2.03 ng/mL 
(male)/7.25 ng/mL (female), AUC0-24h 37.4 h*ng/mL (male)/65.5 h*ng/mL (female) in 
minipigs. Exposure (AUC) in humans was not calculated due to the lack of quantifiable 
plasma concentrations following topical KX2-391 administration. However, the maximum 
Cmax value at the NOAEL in rats and minipigs is approximately 24 and 5 times greater than 
the maximum plasma KX2-391 concentration of 1.42 ng/mL achieved in the clinic 
(Study KX01-AK-002). 
Other dermal toxicity studies with KX2-391 showed that KX2-391 ointment may be 
sensitizing to the skin (Buehler assay and murine local lymph node assay), that KX2-391 
ointment was negative for phototoxicity, and that KX2-391 ointment was an irritant to the 
eyes of rabbits after single application (effects cleared within 3 days post dose). 
KX2-391 was negative in a bacterial mutagenicity study (Ames test). KX2-391 caused 
chromosomal aberrations in Chinese Hamster Ovary (CHO) cells at very high doses that are 
not likely to be clinically relevant. 
Studies of the effects of KX2-391 oral on reproduction and fetal development have been 
performed. In embryo-fetal development studies in rats and rabbits, KX2-391 was 
administered orally in order to increase systemic exposure.  Embryo and fetal toxicity, 
LQFOXGLQJLPSODQWDWLRQORVVDQGIHWDOPDOIRUPDWLRQVRFFXUUHGDWRUDOGRVHVRIPJNJ
(rats) and 3 mg/kg (rabbits). The no-effect doses for fetal and reproductive effects were 
0.5 mg/kg (rats) and 1 mg/kg (rabbits). At these doses, maternal Cmax and AUC0-8 h systemic 
exposures to KX2-391 were 25.4 ng/mL and 82.4 h*ng/mL (rats, Day 17) and 144 ng/mL 
and 251 h*ng/mL (rabbits, Day 18), respectively. Systemic plasma exposure (AUC) in 
humans could not be determined due to the lack of quantifiable plasma concentrations across 
multiple timepoints. However, maternal Cmax values at the NOAEL in rats and rabbits are 
approximately 18 and 100 times greater than the highest KX2-391 plasma concentration 
achieved clinically of 1.42 ng/mL (Study KX01-AK-002). 


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2.1.4 
Clinical Experience with KX2-391 
2.1.4.1 
KX2-391 in Cancer (Oral) 
KX2-391 has been administered orally as a treatment for cancer to approximately 
120 patients with various types of malignancies in 4 clinical studies sponsored by Athenex, 
Inc.  A summary of the safety information from these patients is provided in an appendix of 
the KX2-391 Ointment Investigator’s Brochure. 
Due to the differences in route of administration and short duration of treatment (5 days), 
topical KX2-391 has minimal systemic exposure and is not likely to have the same toxicity 
profile as oral KX2-391. 
2.1.4.2 
KX2-391 as a Topical Treatment for Actinic Keratosis 
To date, 2 clinical studies have been conducted to evaluate the activity and safety of 
KX2-391 Ointment 1% in subjects with AK. 
Study KX01-AK-01-US, a Phase 1, safety, tolerability, and pharmacokinetic study, 
demonstrated that KX2-391 Ointment 1% was well-tolerated and showed clinical activity in 
30 adults with AK on dorsal forearm when given at 50 or 200 mg daily over 3 or 
5 consecutive days in an area of 25 or 100 cm2.  Most subjects experienced mild to moderate 
and transient local skin reactions (LSRs).  The majority of the LSRs observed were erythema 
and flaking/scaling that peaked around Day 5-10, before returning to or close to baseline.  
Symptoms of pruritus, stinging, and burning at the treatment area were generally mild and 
transient.  There were no serious adverse events (SAEs) or deaths, and no subjects 
discontinued due to an adverse event (AE). 
Study KX01-AK-002, an ongoing Phase 2a, open-label, sequential group study, evaluated 
the activity and safety of KX2-391 Ointment 1% when applied daily in a treatment area of 
25 cm2 for 3 consecutive days (n=84 subjects) or 5 consecutive days (n=84 subjects) in adults 
with AK on face or scalp.  Preliminary data showed that most of the 168 subjects treated had 
mild to moderate LSRs (primarily erythema and flaking/scaling.  Eleven (6.5%) subjects had 
16 treatment-emergent adverse events (TEAEs) considered treatment-related by the 
Investigator.  Eight of these subjects had mild application site reactions including pruritus, 
tenderness, or stinging.  The remaining AEs considered by the Investigator to be treatment-
related were mild headache, mild to moderate dizziness, mild arthralgia, or mild darkening of 
hair color near the treatment area.  All treatment-related TEAEs resolved prior to or 
stabilized by Day 57.  Four subjects reported 5 treatment-emergent SAEs.  All SAEs were 
considered unrelated to study drug.  No subject discontinued treatment due to AEs. 
Thirty-six of 84 subjects (43%) in the 5-day regimen and 27 of 84 subjects (32%) in the 
3-day regimen had 100% clearance of AK lesions in the treatment area on Day 57. 
Plasma concentrations of KX2-391 were measured in Study KX01-AK-002 using a validated 
liquid chromatography/tandem mass spectrometry (LC-MS/MS) assay with a lower limit of 
quantification (LLOQ) of 0.1 ng/mL.  Pharmacokinetic results showed that following 3 or 


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5 consecutive days of treatment with KX2-391 Ointment 1%, low systemic exposure 
(< 2 ng/mL) and limited drug accumulation were observed. 
Details of both studies are available in the KX2-391 Ointment Investigator’s Brochure. 
2.2 
Study Rationale 
Actinic keratosis represents the initial intra-epidermal manifestation of abnormal 
keratinocyte proliferation having the potential to progress to squamous cell carcinoma (SCC).  
Squamous cell carcinoma is the second leading cause of skin cancer deaths in the US, with 
up to 65% of SCC arising from pre-existing actinic keratoses.1,2  The risk of progression has 
been determined to be between 0.025% and 16% per year,1,3 and the calculated lifetime risk 
of malignant transformation for a patient with AK lesions followed up for 10 years is 
between 6.1% and 10.2%.4  The rationale behind treating every AK lesion is based on the 
difficulty in predicting which single AK lesion will progress to SCC.5,6  The goal of 
treatment is to completely eliminate AK lesions, thereby minimizing their risk of progression 
to invasive SCC, and reducing the potential to metastasize and cause death, while obtaining 
the best cosmetic outcomes. 
2.3 
Potential Risks and Benefits 
Preliminary results of studies KX01-AK-01-US and KX01-AK-002 indicate that KX2-391 
Ointment 1% administered once daily for up to 5 days demonstrates clinically relevant 
activity in the treatment of AK lesions on both the face and scalp, as well as on the dorsal 
forearm.  Data from KX01-AK-002 suggest that the 5-day regimen of KX2-391 Ointment 
1% has greater activity (43%) than the 3-day regimen (32%). 
Preliminary safety results from both studies showed that KX2-391 Ointment 1% is safe and 
well tolerated.  Even though LSRs (primarily erythema and/or flaking/scaling) were reported 
by the majority of treated subjects, they were generally mild or moderate in severity and 
mostly transient.  The treatment-related TEAEs that subjects experienced mainly consisted of 
mild application site reactions such as itching, burning, stinging, tenderness, and pain.  No 
subjects discontinued treatment due to AEs and no treatment-related SAEs were reported.  
Based on these findings, the clinical benefit of treating actinic keratosis, a precancerous 
condition, with a short course of topical KX2-391 outweighs the risk of transient LSRs 
observed. 
At systemic KX2-391 concentrations that were significantly higher than those observed 
following topical administration in humans, KX2-391 was associated with testicular toxicity 
in multiple-dose nonclinical toxicity studies in animals.  As a precaution, male subjects must 
agree to practice medically acceptable contraception during study participation and for at 
least 90 days after stopping treatment. 


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3 
STUDY OBJECTIVES AND ENDPOINTS 
3.1 
Primary Objective and Endpoint 
The primary objective of the study is to evaluate the efficacy of topical KX2-391 Ointment 
1% once daily for 5 consecutive days compared to vehicle control in terms of 100% 
clearance at Day 57 in the treatment of adults with AK, when applied to a contiguous area of 
25 cm2 on the face or scalp.  
The primary endpoint will be complete (100%) clearance rate of AK lesions, defined as the 
proportion of subjects at Day 57 with no clinically visible AK lesions in the treatment area. 
3.2 
Secondary Objectives and Endpoints 
The secondary objectives of the study are: 
x To evaluate the safety of topical KX2-391 Ointment 1% once daily for 5 consecutive 
days in terms of LSRs and other safety evaluations such as AEs and laboratory 
assessments 
x To comSDUHWKHUDWHVRISDUWLDOUHVSRQGHUVGHILQHGDVFOHDUDQFHRI$.OHVLRQV
in the treatment area on the face or scalp at Day 57 between the KX2-391 Ointment 
1%-treated group and vehicle-treated group  
x To determine the recurrence of AK in the treatment area up to 12 months post-Day 57 
in subjects who had complete clearance at Day 57 after 5 consecutive days of 
treatment with KX2-391 Ointment 1%  
x To evaluate the safety of topical KX2-391 Ointment 1% within the treatment area 
during the Recurrence Follow-up Period. 
The secondary endpoints are: 
Efficacy: 
Key Secondary Endpoint: 
x Partial clearance rate of AK lesions, defined as the proportion of subjects at Day 57 
with a 75% reduction in the number of AK lesions identified at Baseline (Day 1 
predose) in the treatment area 
Additional Endpoint: 
x Recurrence rate of AK lesions in subjects who achieved complete clearance at Day 57  
Safety: 


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x Evaluation of LSRs, pigmentation and scarring in the treatment area, AEs, SAEs, 
events of special interest, clinical laboratory data, and other safety assessments (vital 
signs, physical examinations [PEs], electrocardiograms [ECGs]) 
x AEs within the treatment area after Day 57 up to 12 months post-Day 57 
4 
INVESTIGATIONAL PLAN 
4.1 
Overall Study Design and Plan 
This is a double-blind, vehicle-controlled, randomized, parallel group, multicenter study to 
evaluate the efficacy and safety of KX2-391 Ointment 1% administered topically on the face 
or scalp of adult subjects with AK. 
Enrollment will be controlled so that approximately two thirds of subjects enrolled will be 
treated on the face and approximately one third of subjects enrolled will be treated on the 
scalp.  A sufficient number of subjects will be screened to randomize approximately 
300 subjects.  At each site, a minimum of 10 subjects and a maximum of 20 subjects are 
projected to be enrolled. 
The study consists of Screening, Treatment, a Response Assessment Period, and a 
Recurrence Follow-up Period.  After a Screening Period of up to 28 days, subjects will return 
to the site for confirmation of eligibility.  Eligible subjects will be randomized on Day 1 to 
treatment in a 1:1 (KX2-391 Ointment 1% or vehicle) ratio in each treatment area subgroup. 
The treatment area will be marked with indelible marker at Baseline (Day 1 predose) at the 
investigational site.  Subjects will be given verbal and written instructions on self-
administration of study drug/vehicle and a study kit containing 5 daily single-dose packets, 
one for each day of treatment.  The first dose will be applied by the subject under the 
supervision of study site personnel.  Subjects will then take home the study kit containing the 
remaining single-dose packets of study drug for daily self-administration on the next 
4 consecutive days. 
Subjects will return to the clinical sites for assessments at the Response Assessment Visits at 
Days 5, 8, 15, 29, and 57. 
All subjects who have unresolved LSRs, hypo- or hyper- pigmentation, scarring in the 
treatment area, or treatment-related AEs at Day 57 will return for additional follow-up, which 
includes standardized photography of the treatment area, every 7 to 28 days until resolution, 
returned to baseline, or deemed stabilized by the Investigators. 
Subjects who achieve 100% clearance of AK lesions in the treatment area at Day 57 will 
continue in the Recurrence Follow-up Period to determine recurrence rate and safety for up 
to 12 months following the Day 57 Visit.  Visits during the Recurrence Follow-up Period will 
occur every 3 months.  Subjects who develop AK lesions in the treatment area during the 
Recurrence Follow-up Period will be discontinued at the time of recurrence. 


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An overview of the study design is presented in Figure 1. 
Figure 1 Study Design for KX01-AK-004 
4.2 
Screening Period 
Screening (Visit 1) will occur between Day –28 and Day –1.  Subject eligibility will be 
established during the Screening Period.   
Details of screening procedures/assessments are provided in Section 7.1. 
4.3 
Treatment Period 
The Treatment Period will be Days 1 to 5.  Protocol eligibility will be confirmed at Baseline 
(Day 1 predose). 
All screening and baseline assessments should be evaluated for acceptability prior to 
randomization of the subject.  Eligible subjects will be randomized separately for face and 
scalp to treatment in a 1:1 ratio of KX2-391 Ointment 1% or vehicle (see Section 6.3). 
Baseline and Treatment Period procedures and assessments, and timing thereof, are shown in 
Table 1; details are provided in Section 7.2 and Section 7.3, respectively. 


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4.4 
Response Assessment Period 
Subjects will return to the clinical sites for Response Assessment Visits postdose on Day 5 
(Visit 3) and on Days 8, 15, 29, and 57 (Visits 4 through 7).  Procedures and assessments and 
timing thereof during the Response Assessment Period are shown in Table 1 and the details 
are provided in Section 7.3. 
All subjects who have unresolved LSRs, hypo- or hyper-pigmentation, scarring in the 
treatment area, or treatment-related AEs at Day 57 will return for additional follow-up, which 
includes standardized photography of the treatment area, every 7 to 28 days until resolution, 
returned to baseline, or deemed stabilized by the Investigators. 
4.5 
Recurrence Follow-up Period 
Subjects who achieve 100% clearance of AK lesions in the treatment area at Day 57 will be 
eligible to continue in the Recurrence Follow-up Period to determine AK recurrence rates 
and evaluate concomitant medications and AEs in the treatment area for up to 12 months 
post-Day 57. 
Procedures and assessments and timing thereof during the Recurrence Follow-up Period are 
shown in Table 1 and the details are provided in Section 7.5.  Subjects who develop AK 
lesions in the treatment area during the Recurrence Follow-up Period will be discontinued at 
the time of recurrence. 
4.6 
Discussion of Study Design, Including Choice of Dosing and 
Control Groups 
This is a multicenter, randomized, double-blind, vehicle-controlled, parallel group, efficacy 
and safety study of KX2-391 Ointment 1% administered topically on the face or scalp of 
adult subjects with AK for 5 consecutive days.   
The dosing regimen for this study is based on the Phase 2a study (KX01-AK-002).  
KX01-AK-002 is an open-label, sequential group, non-randomized, multi-center study that 
evaluated the dosing regimen of daily dosing for either 3 or 5 consecutive days of KX2-391 
Ointment 1% on a treatment area of 25 cm2 on the face or scalp that contained 4 to 8 AK 
lesions in 168 adults (84 subjects per cohort).  Preliminary analyses showed that a higher 
percentage of subjects achieved complete clearance of AK on Day 57 for the 5-day treatment 
group (43%) than the 3-day treatment group (32%).  For both the 5-day and 3-day treatment 
groups, KX2-391 Ointment 1% was found to be safe, well tolerated and minimally absorbed 
throughout treatment and follow up for both cohorts.  Thus, these data support the evaluation 
of KX2-391 Ointment 1% once daily topical application for a 5-consecutive day dosing 
regimen for the treatment of adults with AK on the face or scalp in this Phase 3 double-blind, 
vehicle-controlled study.  The 12-month Recurrence Follow-up Period allows for long-term 
evaluation of AK recurrence rates and safety. 


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5 
STUDY POPULATION 
Eligible subjects will be adults \HDUVRIDJHwith a diagnosis of clinically typical AK 
on the face or scalp. 
A sufficient number of subjects will be screened to randomize approximately 300 subjects at 
approximately 25 to 40 sites.  A minimum of 10 subjects and a maximum of 20 subjects are 
projected to be enrolled at each site. 
5.1 
Inclusion Criteria 
Subjects must meet all the following criteria to be included in this study: 
1. 0DOHVDQGIHPDOHV\HDUVROG 
2. A treatment area on the face or scalp that: 
x is a contiguous area measuring 25 cm2 
x contains 4 to 8 clinically typical, visible, and discrete AK lesions  
3. Subjects who in the judgment of the Investigator, are in good general health based on: 
x medical history 
x physical examination (PE) findings 
x vital signs  
x ECGs, clinical chemistry, hematology, and urinalysis results  
4. Females must be postmenopausal (>45 years of age with at least 12 months of 
amenorrhea), surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal 
ligation); or, if of childbearing potential, must be using highly effective contraception for 
at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and 
must agree to continue to use highly effective contraception for at least 30 days following 
their last dose of study treatment.  Highly effective contraception includes oral hormonal 
contraceptives, hormonal contraceptive implant, injection or patch, intrauterine device or 
complete abstinence from sexual intercourse. 
5. Sexually active males who have not had a vasectomy, and whose partner is 
reproductively capable, must agree to use barrier contraception from Screening through 
90 days after their last dose of study treatment. 
6. All subjects must agree not to donate sperm or eggs or attempt conception from 
Screening through 90 days following their last dose of study treatment. 
7. Females of childbearing potential must have a negative serum pregnancy test at 
Screening and a negative urine pregnancy test on Day 1 prior to randomization. 
8. Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use 
of tanning beds, to the face or scalp  
9. Able to comprehend and are willing to sign the informed consent form (ICF). 


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5.2 
Exclusion Criteria 
Subjects who meet any of the following criteria will be excluded from this study: 
1. Clinically atypical and/or rapidly changing AK lesions on the treatment area, eg, 
hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on two previous 
occasions) and/or cutaneous horn 
2. Location of the treatment area is: 
x On any location other than the face or scalp 
x Within 5 cm of an incompletely healed wound 
x Within 5 cm of a suspected basal cell carcinoma (BCC) or SCC 
3. Been previously treated with KX2-391 Ointment 
4. Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57 
5. Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, 
photodynamic therapy, or other treatments for AK within the treatment area or within 
2 cm of the treatment area, within 8 weeks prior to the Screening visit 
6. Use of the following therapies and/or medications within 2 weeks prior to the Screening 
visit: 
x Cosmetic or therapeutic procedures (eg, use of liquid nitrogen, surgical excision, 
curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) 
within the treatment area or within 2 cm of the selected treatment area 
x Acid-containing therapeutic products (eg, salicylic acid or fruit acids, such as alpha- 
and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels 
within the treatment area or within 2 cm of the selected treatment area  
x Topical salves (non-medicated/non-irritant lotion and cream are acceptable) or topical 
steroids within the treatment area or within 2 cm of the selected treatment area; 
artificial tanners within the treatment area or within 5 cm of the selected treatment 
area 
7. Use of the following therapies and/or medications within 4 weeks prior to the Screening 
visit:  
x Treatment with immunomodulators (eg, azathioprine), cytotoxic drugs (eg, 
cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/interferon 
inducers 
x Treatment with systemic medications that suppress the immune system (eg, 
cyclosporine, prednisone, methotrexate, alefacept, infliximab) 
8. Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to 
the Screening visit 
9. A history of sensitivity and/or allergy to any of the ingredients in the study medication 


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10. A skin disease (eg, atopic dermatitis, psoriasis, eczema) or condition (eg, scarring, open 
wounds) that, in the opinion of the Investigator, might interfere with the study conduct or 
evaluations, or which exposes the subject to unacceptable risk by study participation 
11. Other significant uncontrolled or unstable medical diseases or conditions that, in the 
opinion of the Investigator, would expose the subject to unacceptable risk by study 
participation 
12. Females who are pregnant or nursing 
13. Participated in an investigational drug trial during which an investigational study 
medication was administered within 30 days or 5 half-lives of the investigational product, 
whichever is longer, before dosing 
5.3 
Subject Withdrawal / Discontinuation Criteria  
The Investigator may withdraw a subject from study treatment or withdraw the subject from 
the study at any time for safety or administrative reasons.  The subject may decide to 
discontinue study treatment or withdraw from the study at any time for any reason.  The 
Investigator must document the reason for discontinuing a subject from treatment or from the 
study if known, or why the subject withdrew consent, if applicable.  Subject disposition 
information will be collected on the electronic case report form (eCRF). 
Subjects who do not complete 5 days of treatment and withdraw from study treatment (for 
reasons other than death or withdrawal of consent) will be encouraged to continue the 
post-treatment visits.  At the time of withdrawal from the study, the subject should complete 
the early termination assessments (Day 57 assessments) (Table 1).  A subject who does not 
return for the post-treatment visits will be followed up by mail, phone, or other means to 
gather information such as the reason for failure to return, the presence or absence of AEs, 
and clinical courses of signs and symptoms.  This information will be recorded in the eCRF. 
Subjects who discontinue early from the study will be discontinued for one of these primary 
reasons: 


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x AE(s) 
x Lost to follow-up 
x Withdrawal of consent (subjects will be asked but not required to provide a reason) 
x Study terminated by Sponsor 
x Noncompliance (specify) 
x AK recurrence during the Recurrence Follow-up Period prior to the 12-month visit 
x Investigator decision (specify) 
x Death 
x Other (specify) 
Subjects who do not achieve 100% clearance of AK lesions in the treatment area at Day 57 
will be considered to have completed their participation in the study. 
6 
STUDY TREATMENTS 
6.1 
Identity of Study Drugs 
Treatments administered will be topical KX2-391 Ointment 1% and vehicle ointment. 
6.1.1 
Formulation, Packaging, and Labeling 
KX2-391 Ointment 1% will be supplied in single-use packets, each of which contains 
250 mg of the ointment, equivalent to 2.5 mg of KX2-391 free base.  Vehicle ointment will 
be supplied in the same single-use packets, each of which contains 250 mg of the ointment 
without the active drug.  Each packet is for use as a single-dose application.  Complete 
formulation contents for both KX2-391 Ointment 1% and vehicle ointment are provided in 
the KX2-391 Ointment Investigator’s Brochure. 
Each eligible randomized subject will be assigned an enrollment number and a study kit with 
the same enrollment number.  The study kit will contain 5 packets filled with either KX2-391 
Ointment 1% or vehicle ointment.  Each packet and study kit will be labeled in accordance 
with national regulations.  Detailed information regarding the study drugs, including labeling 
information, will be in the Pharmacy Manual provided to the site. 
The following treatments will be administered to subjects in this study (Table 2).  


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Table 2 
Treatments in KX01-AK-004 
Investigational 
Product 
Strength 
Size of 
Treatment 
Area 
Number Applications and 
Frequency 
Study Days 
Administered 
KX2-391 Ointment 1% 
1% 
25 cm2 
1 application once daily for 
5 consecutive days  
Days 1-5 
Vehicle Ointment 
N/A 
25 cm2 
1 application once daily for 
5 consecutive days  
Days 1-5 
N/A = not applicable 
6.1.2 
Storage Conditions 
Study drug will be stored in accordance with labeled storage conditions. 
6.2 
Dosage and Administration of Study Drugs 
6.2.1 
Administration of Study Drugs 
At Baseline (Day 1 predose), subjects will receive verbal and written instructions on how to 
apply the topical medication and how to care for the treatment area (Appendix 1). 
The study medication is for external topical use on the treatment area.  The treatment area 
will be marked with indelible marker at Baseline (Day 1 predose) at the investigational site 
(see Section 7.2.3).  Subjects will be provided with a study kit comprised of individual plastic 
bags with 5 single-dose packets containing either KX2-391 Ointment 1% or vehicle ointment 
and a dosing log. 
The first dose will be administered by the subject under the supervision of study personnel on 
Day 1 at the site.  Subjects will self-administer the remaining single-dose packets once daily 
at home for the next 4 consecutive days.  Study medication should be applied each day at 
approximately the same time.  It is preferable that study drug application is done early in the 
day.  The treatment area should not be touched or wet for approximately 12 hours after 
application. 
See Appendix 1 for subject instructions for study drug application.  It is imperative that 
subjects wash hands immediately with water and soap after applying the ointment.  The 
subject instructions also contain additional details including precautions associated with 
ointment application during the 5 days of treatment and throughout the study.   
6.2.1.1 
Instructions in the Event of Ocular Exposure 
Subjects will be instructed to avoid getting ointment in their eyes.  If ointment does get in the 
eyes, the subject is to flush their eyes with water immediately and extensively.  The subject 
must immediately contact the Investigator who will provide further instructions and will refer 


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the subject to an ophthalmologist.  The ophthalmologist’s assessment will be included in the 
report of ocular exposure as an event of special interest (see Section 8.2.3). 
6.2.2 
Criteria for Interruption of Treatment/Dose Adjustments 
Not applicable; dose adjustment is not allowed. 
6.3 
Randomization/Method of Assigning Subjects to Treatment 
Groups 
Enrollment will be controlled so that approximately two thirds of subjects enrolled will be 
treated on the face and approximately one third of subjects enrolled will be treated on the 
scalp.  Eligible subjects will be randomized to treatment in a 1:1 (KX2-391 Ointment 1% or 
vehicle) ratio in each treatment area subgroup. 
Subjects will be assigned to treatments in a double-blinded manner based on a computer-
generated randomization scheme.  Based on the randomization scheme, 2 lists of enrollment 
numbers will be issued to each site; one list will be for subjects with the treatment area on the 
face and the other list will be for subjects with the treatment area on the scalp.  Study kits 
bearing corresponding enrollment numbers will be provided to the site.  One set of kits will 
be provided for subjects with the treatment area on the face and the second set of kits will be 
provided for subjects with the treatment area on the scalp. 
Enrollment numbers and study kits are distributed sequentially.  The first eligible subject 
with AK lesion on the face will be assigned the first enrollment number for treatment of the 
face and given a study kit bearing the same enrollment number on Day 1 of treatment.  The 
next eligible subject with AK lesions on the face will receive the next enrollment number and 
corresponding study kit in a sequential order. 
The same procedure will occur for subjects with the treatment area on the scalp.  On Day 1, 
the first eligible subject with AK lesions on the scalp will be assigned the first enrollment 
number for treatment on the scalp and given a study kit bearing the same enrollment number.  
The next eligible subject with AK lesions on the scalp will receive the next enrollment 
number and corresponding study kit in a sequential order. 
Refer to the Pharmacy Manual for details of procedures of study kit dispensing and 
documentation. 
6.3.1 
Blinding  
The Sponsor, contract research organizations (CROs) involved in the clinical conduct of the 
study, the Investigators, study site personnel and study subjects will be blinded to the 
treatment that is assigned to each subject.  The integrity of this clinical study must be 
maintained by observing the treatment blind.  See Section 8.2.5 for breaking the blind. 


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6.4 
Prior and Concomitant Medications / Therapy 
6.4.1 
Prior Medications / Therapy 
All medications (prescription and nonprescription including vitamins and dietary 
supplements), treatments, and procedures taken 28 days before Day 1 are considered prior 
therapy and will be recorded in the eCRF.  An AK treatment history of the face or scalp will 
be recorded on the AK Treatment History eCRF (see Section 7.1.4). 
6.4.2 
Concomitant Medications/Therapy 
Concomitant medication/therapies are any new or existing therapy received by the subject 
after signing the ICF through the final subject contact in the study.  Concomitant 
medication/therapies will be recorded in the eCRF. 
Use of sunblock from Day 15 onward or any topical products for treatment of LSRs in the 
treatment area allowed by the Investigator will be recorded in the Concomitant Medication 
eCRF up to Day 57. 
During the Recurrence Follow-up Period, sunblock and non-medicated topical products can 
be used in the treatment area.  During the Recurrence Follow-up Period, only concomitant 
medications/therapies for the treatment of AEs in the treatment area and those that may affect 
the assessment of AK lesion recurrence in the treatment area will be entered in the eCRF. 
6.4.3 
Prohibited Medication/Therapy  
Use of any treatment for AK lesions other than study drug on the treatment area is prohibited 
during the study.  Subjects will be reminded that AK lesions located outside the treatment 
area may be treated by lesion-directed treatment only, eg, cryotherapy or biopsy. 
Prohibited medications are as follows: 
Prohibited drug products and treatments that might influence or mask the effects of treatment 
until Day 57 include:  immunomodulators or immunosuppressive therapies, cytotoxic drugs, 
interferon/interferon inducers, topical or systemic steroids, 5-FU, ingenol mebutate, 
imiquimod, diclofenac, topical or systemic retinoids, topical salicylic acid, bichloroacetic 
acid, trichloroacetic acid, acid-containing therapeutic products, benzoyl peroxide, 
chemodestruction, medicated/therapeutic topical salves, photodynamic therapy, psoralen plus 
UVA or UVB therapy, artificial tanner, excessive or prolonged exposure to UV light source.9 
Subjects are prohibited from applying any topical products, including but not limited to, 
lotions, creams, and ointments, moisturizers, sunscreen, artificial tanners, or make-up to the 
treatment area up until the end of Day 57 (Visit 7), except when those medications are 
prescribed by the Investigator for the management of LSRs.  Subjects should avoid direct sun 
or UV exposure to the treatment area throughout the study.  However, from Day 15 onward, 
if a subject is unable to avoid direct sun or UV exposure to the treatment area, the 
Investigator may allow the use of sunblock only. 


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Subjects have unrestricted use of nonmedicated topical products on areas outside of the 
treatment area during the study. 
During the Recurrence Follow-up Period, use of treatments that may interfere with the 
assessment of AK recurrence in the treatment area are prohibited. This includes use of AK 
treatment and medicated topical products in the treatment area and use of systemic therapies 
(eg, immunosuppressive agents and systemic AK treatment) that may interfere with the 
assessment of AK recurrence. 
Any subjects who start systemic or topical therapies for the treatment of AK will be 
withdrawn from the study. 
The decision to administer a prohibited medication/treatment is done with the safety of the 
study subject as the primary consideration. 
6.4.4 
Other Prohibitions and Restrictions during Study 
There are no restrictions during the study on smoking/tobacco use, diet, alcohol/caffeine, 
water or other beverages, or physical activity. 
After self-application, subjects will avoid touching or wetting the treatment area for 
approximately 12 hours.  When washing the treatment area, wash it gently with a mild, non-
abrasive, non-medicated soap or shampoo.  
The treatment area should not be occluded with bandages, band aids, tight-fitting scarfs or 
caps.  The treatment area should not be exposed to excessive sunlight or UV light.  See 
Appendix 1 for all prohibited activity. 
6.5 
Drug Accountability and Treatment Compliance 
6.5.1 
Drug Supplies and Accountability 
Drug supplies must be kept in an appropriate secure area (eg, locked cabinet) and stored 
according to the conditions specified on the drug labels. 
The Investigator and study staff will be responsible for the accountability of all clinical 
supplies (eg, shipment, dispensing, inventory, and record keeping) following the Sponsor’s 
instructions.  In this matter, the Investigator and study staff must adhere to Good Clinical 
Practice (GCP) guidelines, as well as local or regional requirements. 
Under no circumstances will the Investigator allow the study drugs to be used other than as 
directed by this protocol.  Clinical supplies will be dispensed only by an appropriately 
qualified person and will not be dispensed to any individual who is not enrolled in the study. 
An accurate and timely record of the receipt of all clinical supplies and dispensing of study 
drug to the subject must be maintained. 


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All forms will be provided by the Sponsor (or its designee).  Any comparable forms that the 
investigational site wishes to use must be approved by the Sponsor.  A copy of the drug 
accountability record must be provided to the Sponsor (or its designee). 
The clinical research associate (CRA) will review drug accountability during monitoring site 
visits. 
The Investigator (or site personnel) must not destroy any drug labels or any partly used or 
unused drug supply.  Post-Day 57, and as appropriate during the study, the Investigator (or a 
designated pharmacist) will return all used and unused drug packets, study kits, drug labels, 
and a copy of the completed drug disposition form to the clinical supply vendor. 
Refer to the Pharmacy Manual for instructions and contact information. 
6.5.2 
Treatment Compliance 
Subjects will return the used ointment packets (or unused ointment, if not administered) back 
to the clinical site on Day 5 (Visit 3) postdose, to check compliance. 
The dosing logs for each subject will be kept during the study.  The CRAs will review 
treatment compliance during monitoring site visits. 
7 
STUDY PROCEDURES AND ASSESSMENTS 
7.1 
Screening Assessments 
All screening assessments will be performed after the subject provides informed consent 
(Table 1).  Screening (Visit 1) will occur between Day -28 and Day -1. 
Subject screening numbers will be assigned at Visit 1. 
The eCRF must be completed to indicate whether the subject is eligible to participate in the 
study and to provide reasons for screen failure, if applicable. 
7.1.1 
Informed Consent 
Informed consent will be obtained after the study has been fully explained to each subject 
and before the conduct of any screening procedures or assessments.  Documentation will be 
required (documented in the clinic notation) to confirm that the Investigator ensured that the 
informed consent process was done correctly, the subject understood what to expect, and 
agreed to participate. 
Procedures to be followed when obtaining informed consent are detailed in Section 10.3.2. 
7.1.2 
Inclusion/Exclusion Criteria 
Subject eligibility will be confirmed per the inclusion/exclusion criteria at Screening. 


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7.1.3 
Demography 
Subject demography information will be collected at Screening.  Demography information 
includes age at time of consent, sex, race/ethnicity. 
7.1.4 
Medical/Surgical and Actinic Keratosis History 
Medical and surgical history and current medical conditions will be recorded at Screening. 
Medical history will include:  
x Significant medical and surgical history; childhood diseases and common colds are 
not required unless it is ongoing at Screening 
x The initial diagnosis date of AK on the face or scalp, depending on the selection of 
the treatment area for the study 
x An AK treatment history of the face or scalp including all commercial and 
investigational products and surgical modalities dating back to the initial diagnosis.  
x History of cancers including skin cancers, eg, BCC, SCC, melanoma. 
7.1.5 
Prior Medications 
All medications (prescription and nonprescription including vitamins and dietary 
supplements), treatments, and therapies taken 28 days before Day 1 will be recorded at 
Screening. 
7.1.6 
Fitzpatrick Skin-Type Classification 
The Fitzpatrick Skin-Type is a skin classification system8 which measures 2 components 
(genetic disposition and reaction to sun exposure).  Skin-types range from very fair (Type I) 
to very dark (Type VI).  Subjects’ skin will be typed using this classification system at 
Screening. 
7.1.7 
Expanded Dermatological Examination 
An expanded dermatological examination to cover sun-exposed areas where photo-damage is 
likely will be conducted at Screening only. 
7.1.8 
Treatment Area Identification and AK Lesion Count Examination 
At the Screening visit, a dermatologist (Investigator or Subinvestigator) will identify a 
contiguous treatment area affected with AK on the face or scalp for each subject that 
measures 25 cm2 and contains 4 to 8 AK lesions that are clinically typical, visible, and 
discrete.  A dermatologist (Investigator or Subinvestigator) will perform a count of AK 
lesions (lesion count) for all subjects. 


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7.1.9 
Physical Examinations  
A complete PE will be performed at Screening and will include weight and an assessment of 
the head, eyes, ears, nose, and throat (HEENT), gastrointestinal, cardiovascular, respiratory, 
musculoskeletal, and neurological systems.  Height will be measured at Screening only.  An 
expanded dermatological examination will be conducted at Screening only (Section 7.1.7).  
The complete PE will be part of the baseline assessments. 
7.1.10 
Vital Signs 
Vital signs will be recorded at Screening.  Vital sign (pulse rate, systolic and diastolic blood 
pressure, respiratory rate, and body temperature) measurements will be taken after the subject 
has been seated for at least 5 minutes.  Serial vital signs may be obtained to confirm accurate 
readings. 
7.1.11 
Electrocardiograms 
Electrocardiogram training, equipment, and a procedural manual will be provided to the site 
by the central ECG vendor.  The ECG vendor and the Sponsor will ensure that the study site 
ECG operator is properly trained prior to start of study. 
A standard 12-lead ECG will be obtained at Screening.  Subjects must be in the recumbent 
position for a period of 5 minutes prior to the ECG.  Screening ECGs must be reviewed prior 
to the subject being randomized. 
ECGs will be transferred electronically to the central ECG vendor. 
7.1.12 
Laboratory Measurements 
Samples for clinical laboratory testing (hematology, chemistry, urinalysis) will be collected 
at Screening.  Clinical laboratory testing will be part of the baseline assessments.  See 
Section 7.3.4.9 for further details about laboratory tests. 
7.1.13 
Pregnancy Testing 
In females of childbearing potential, a serum pregnancy test will be obtained at Screening.  
Test results must be reviewed before randomization of subjects. 
7.2 
Baseline Assessments 
All baseline assessments should be completed by Day 1 (Visit 2) prior to randomization, 
according to the Schedule of Procedures and Assessments (Table 1). 
7.2.1 
Inclusion/Exclusion Criteria 
Subject eligibility will be re-confirmed per the inclusion/exclusion criteria at Baseline. 


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7.2.2 
Prior Medications 
All prior medications (prescription and nonprescription including vitamins and dietary 
supplements), treatments, and therapies will be confirmed at Baseline. 
7.2.3 
Treatment Area Identification 
At Baseline (Day 1 predose), the Investigator will confirm the 25 cm2 treatment area affected 
with 4 to 8 AK lesions on the face or scalp that was identified at Screening. 
At Baseline (Day 1 predose), the location and shape of the treatment area and the specific 
AK lesions will be recorded on an acetate transparency sheet gridded with 1 cm2 squares.  
The Investigator or Subinvestigator will identify the treatment area by:  
1. 
Placing the transparency sheet over the treatment area 
2. 
With a fine-tip indelible marker: 
x Mark at least 3 anatomical landmarks in the vicinity of the treatment area on the 
transparency sheet.  Examples of landmarks could be bony prominences, scars, 
moles, seborrheic keratosis, and veins. 
x Mark the outline of the treatment area on the transparency sheet. 
x Mark the location of each of the AK lesions inside the treatment area on the 
transparency sheet. 
3. 
On the subject’s skin, outline the treatment area with dots and dashes with the 
indelible marker. 
The transparency sheet will be kept at the site and will be used to locate the treatment area 
and AK lesions during the follow-up visits. 
7.2.4 
Actinic Keratosis Lesion Count 
A dermatologist (Investigator or Subinvestigator) will perform a count of clinically visible AK 
lesions (lesion count) for all subjects at Baseline (Day 1 predose).  The same Investigator or 
Subinvestigator will conduct the lesion count at all visits for an individual subject. 
For this assessment, an AK lesion should be counted only if it is completely inside the 
treatment area. 
7.2.5 
Focused Dermatological Exam of Treatment Area 
At Baseline (Day 1 predose), the focused dermatological exam of treatment area will include 
evaluation for LSRs, hypo- or hyper-pigmentation, and scarring (see below).  These 
assessments will be used as baseline assessments. 


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7.2.5.1 
Local Skin Reactions 
At Baseline (Day 1 predose), after the assessment of AEs, the Investigator or Subinvestigator 
will assess for LSRs on the treatment area.  The same Investigator or Subinvestigator will 
conduct the LSR assessment at all visits for an individual subject. 
LSR signs on the treatment area include the following:  erythema, flaking/scaling, crusting, 
swelling, vesiculation/pustulation, and erosion/ulceration.  These signs will be assessed using 
a 4-point grading scale; 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct 
presence), and 3=severe (marked, intense).  
Application site reactions not classified as LSRs (eg, itching, burning, stinging, tenderness, 
pain) will be reported as AEs. 
LSRs will be reported separately from AEs. 
7.2.5.2 
Pigmentation and Scarring 
At the time of LSR assessment, hypo- and hyper-pigmentation and scarring on the treatment 
area will be assessed by the Investigator or Subinvestigator as being present or absent. 
Pigmentation and scarring will be assessed at Baseline (Day 1 predose), after the assessment 
of adverse events.  The same Investigator or Subinvestigator will assess pigmentation and 
scarring at all visits for an individual subject. 
7.2.6 
Standardized Photography 
At Baseline (Day 1 predose), the Investigator or a qualified staff member must obtain 
standardized photography of each subject’s treatment area before application of study 
medication. 
Care must be taken to ensure the same lighting, background, subject positioning relative to 
the camera and camera settings are used for each photograph.  Equipment, supplies and 
detailed instructions for obtaining and managing the photographs will be provided to the 
investigational center prior to the initiation of subject enrollment. 
The photographs are to document the appearance of the subjects’ treatment area and to assist 
with the identification and confirmation of the location of the treatment area throughout the 
study. 
7.2.7 
Vital Signs 
Vital signs will be measured at Baseline (Day 1 predose).  See Section 7.1.10 for details. 
7.2.8 
Electrocardiograms 
A 12-lead ECG will be obtained at Baseline (Day 1 predose).  See Section 7.1.11 for details. 


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7.2.9 
Pregnancy Testing 
In females of childbearing potential, a urine pregnancy test will be performed at the site at 
Baseline (Day 1 predose).  Test results must be reviewed before randomization on Day 1. 
7.2.10 
Randomization 
After screening and baseline assessments confirm a subject’s eligibility to participate in the 
study, he/she will be assigned the next enrollment number appropriate for the area being 
treated (see Section 6.3). 
7.2.11 
Instructions for Self-administration of Study Treatment, Dispensing, and 
Return of Study Treatment 
At Baseline (Day 1 predose), subjects will receive both verbal and written instructions 
(Appendix 1) for daily self-administration of study treatment.  Any questions will be 
answered by the clinic staff. 
Randomized subjects will be assigned an enrollment number and a study kit with the same 
enrollment number.  The study kit will have 5 single-dose packets (1 for each day of 
treatment) containing either KX2-391 Ointment 1% or vehicle ointment (see Section 6.1.1).  
The study kit will include a dosing log where the subjects will record the date and time of 
study drug self-administration. 
Subjects will be instructed to place the used packets (including torn pieces) into the plastic 
bags in which they came, seal the plastic bags, put them back into the study kit, and return 
the study kit containing used and unused packets and the dosing log to the clinical site after 
self-administration on Day 5 to check compliance (Section 6.5.2). 
7.3 
Treatment Period and Response Assessment Period 
7.3.1 
Treatment Administration – Days 1-5 
After baseline assessments are completed on Day 1, the first dose of study treatment will be 
applied by the subject under the supervision of study site personnel.  Subjects will then take 
home the study kit containing the remaining single-dose packets of study drug for daily self-
administration on the next 4 consecutive days. 
7.3.2 
Efficacy Assessments 
7.3.2.1 
Actinic Keratosis Lesion Count 
A dermatologist (Investigator or Subinvestigator) will perform a count of clinically visible AK 
lesions (lesion count) for all subjects at the Response Assessment Visits on Days 8, 15, 29, and 
57 (Table 1).  The same Investigator or Subinvestigator will conduct the lesion count at all 
visits for an individual subject. 


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The Investigator or Subinvestigator may use the transparency and/or photograph from Baseline 
to locate the treatment area.  AK lesion counts from previous visits should not be used to assist 
in the assessment of AK lesion count at the current visit.  Only AK lesions completely within 
the treatment area will be counted. 
7.3.3 
Pharmacokinetic, Pharmacodynamic, Pharmacogenomic, and Other 
Biomarker Assessments 
Not applicable 
7.3.4 
Safety Assessments 
Safety assessments will include the monitoring and recording all AEs, SAEs, LSRs, and 
events of special interest. 
At each study visit, subjects will be asked a general question “How have you been since the 
last visit?”.  Adverse events will be recorded at each study visit, before assessment of LSRs, 
pigmentation, and scarring in the treatment area.  Adverse events will be reported separately 
from LSRs. 
Safety assessments will also include vital signs, the performance of PEs, ECGs, laboratory 
evaluation of hematology, biochemistry, and urinalyses, as detailed in the sections below. 
7.3.4.1 
Adverse Events  
All AEs will be assessed periodically through Day 57 (Table 1). 
An AE is any untoward medical occurrence in a patient or clinical investigation subject 
administered an investigational product.  An AE does not necessarily have a causal 
relationship with the medicinal product.  For this study, the study drugs are KX2-391 
Ointment 1% and vehicle ointment. 
The criteria for identifying AEs in this study are: 
x 
Any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease temporally associated with the use of an investigational product, 
whether or not considered related to the investigational product  
x 
Any new disease or exacerbation of an existing disease 
x 
Any deterioration in non-protocol-required measurements of a laboratory value or other 
clinical test (eg, ECG or x-ray) that results in symptoms, a change in treatment, or 
discontinuation of study drug 
x 
Recurrence of an intermittent medical condition (eg, headache) not present pretreatment 
(Baseline) 
All AEs, regardless of relationship to study drug or procedure, should be collected beginning 
from the time the subject signs the study ICF through the final subject contact in the study.  
Subjects who have unresolved LSRs, hypo- or hyper-pigmentation, scarring in the treatment 


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area, or treatment-related AEs at Day 57 will return for additional follow-up every 
7 to 28 days until resolution, returned to baseline, or deemed stabilized by the Investigators. 
Subjects who fail screening primarily due to AE(s) must have the AE(s) recorded in the AE 
eCRF and screen failure reported on the eCRF. 
Subjects with onset of a study treatment-related AEs will be followed until resolution, under 
medical care, or deemed stabilized by the Investigator.  All SAEs must be followed to 
resolution or, if resolution is unlikely, to stabilization. 
All AEs observed during the study will be reported on the eCRF. 
Laboratory Adverse Events 
A treatment-emergent abnormal laboratory test result should be considered as a TEAE if the 
identified laboratory abnormality leads to any type of intervention whether prescribed in the 
protocol or not. 
An abnormal laboratory result should be considered by the Investigator to be an AE if it: 
x 
Results in the withdrawal of study drug 
x 
Results in an intervention, based on medical evaluation (eg, potassium supplement for 
hypokalemia) 
x 
Results in any out-of-range laboratory value that in the Investigator’s judgment fulfills 
the definitions of an AE with regard to the subject’s medical profile 
Abnormal laboratory values should not be listed as separate AEs if they are considered to be 
part of the clinical syndrome that is being reported as an AE.  It is the responsibility of the 
Investigator to review all laboratory findings in all subjects and determine if they constitute 
an AE.  Medical and scientific judgment should be exercised in deciding whether an isolated 
laboratory abnormality should be classified as an AE.  Any laboratory abnormality 
considered to constitute an AE should be reported on the Adverse Event eCRF. 
Electrocardiogram Changes 
Any changes from the baseline ECG will be evaluated for clinical significance.  ECG 
changes that are determined to be clinically significant, regardless of relationship, will be 
reported as an AE. 
For symptomatic ECG abnormalities meeting criteria as SAEs, the study site must submit an 
SAE report, including the ECG report to the Sponsor or designee, using the SAE reporting 
procedures (Section 8.1). 


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7.3.4.1.1 
ASSESSING SEVERITY OF ADVERSE EVENTS 
Every effort must be made by the Investigator to categorize each AE according to its 
severity. 
Adverse events will be graded on a 3-point scale (mild, moderate, severe) and reported in 
detail indicated on the eCRF.  The definitions are as follows: 
Mild 
Discomfort noticed, but no disruption of normal daily activity 
Moderate 
Discomfort sufficient to reduce or affect normal daily activity 
Severe 
 Incapacitating, with inability to work or to perform normal daily activity 
The criteria for assessing severity are different than those used for seriousness (see 
Section 7.3.4.2 for the definition of an SAE). 
7.3.4.1.2 
ASSESSING RELATIONSHIP TO STUDY TREATMENT 
Every effort must be made by the Investigator to categorize each AE according to its 
relationship to the study treatment. 
Items to be considered when assessing the relationship of an AE to the study treatment are: 
x 
Temporal relationship of the onset of the event to the initiation of the study treatment 
x 
The course of the event, especially the effect of discontinuation of study treatment or 
reintroduction of study treatment, as applicable 
x 
Whether the event is known to be associated with the study treatment or with other 
similar treatments 
x 
The presence of risk factors in the study subject known to increase the occurrence of the 
event 
x 
The presence of non-treatment-related factors that are known to be associated with the 
occurrence of the event.  
Classification of Causality 
The relationship of each AE to the study drug will be recorded on the eCRF using the 
following criteria: 
Definitely Related:  A clinical event, including laboratory test abnormality, occurring in a 
plausible time relationship to drug administration, and which cannot be explained by 
concurrent or underlying disease or other drugs or conditions 
Probably Related:  A clinical event, including laboratory test abnormality, with a reasonable 
time sequence to administration of the drug, unlikely to be attributed to concurrent or 
underlying disease or other drugs or conditions  


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Possibly Related:  A clinical event, including laboratory test abnormality, with a reasonable 
time sequence to administration of the drug, but which could also be explained by concurrent 
or underlying disease or other drugs or conditions 
Not Related:  The AE is clearly not related to investigational product and is clearly related to 
underlying disease, environmental or toxic factor(s), or other drug therapy. 
7.3.4.2 
Serious Adverse Events  
All SAEs will be assessed during the Treatment and Response Assessment Periods, on 
Days 1, 5, 8, 15, 29, and 57 (Table 1). 
A SAE is any untoward medical occurrence that at any dose: 
x 
Results in death 
x 
Is life-threatening (ie, the subject was at immediate risk of death from the AE as it 
occurred; this does not include an event that, had it occurred in a more severe form or 
was allowed to continue, might have caused death) 
x 
Requires inpatient hospitalization or prolongation of existing hospitalization 
x 
Results in persistent or significant disability/incapacity 
x 
Is a congenital anomaly/birth defect (in the child of a subject who was exposed to the 
study drug) 
Other important medical events that may not be immediately life-threatening or result in 
death or hospitalization but, when based on appropriate medical judgment, may jeopardize 
the subject or may require intervention to prevent one of the outcomes in the definition of 
SAE listed above should also be considered SAEs.  Medical and scientific judgment should 
be exercised in deciding whether expedited reporting is appropriate in such situations.  
All SAEs must be followed to resolution or, if resolution is unlikely, to stabilization. 
7.3.4.3 
Events of Special Interest 
All events of special interest will be assessed during the Treatment and Response Assessment 
Periods, on Days 1, 5, 8, 15, 29, and 57 (Table 1). 
In addition to the AEs and SAEs described above, events of special interest are to be 
captured and reported in the appropriate eCRF and Events of Special Interest Forms (see 
Section 8.2).  Events of special interest will be considered as SAEs if they meet the criteria 
for an SAE (Section 7.3.4.2). 


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Events of special interest during the Treatment and Response Assessment Periods (Days 1 to 
57) are as follows: 
x Overdose of study medication 
x Pregnancy  
x Ocular exposures to study medication 
x Skin cancers (including BCC, SCC, and melanoma); location and treatment will be 
reported. 
7.3.4.4 
Concomitant Medications 
Concomitant medications will be assessed during the Treatment and Response Assessment 
Periods, on Days 1, 5, 8, 15, 29, and 57 (Table 1).  Any medication (including 
nonprescription medications) or therapy administered to the subject during the course of the 
study (starting at the date of informed consent) will be recorded on the Concomitant 
Medication eCRF up to Day 57.  The Investigator will record any AE on the Adverse Event 
eCRF for which the concomitant medication/therapy was administered. 
Use of sunblock from Day 15 onward or any topical products for the treatment of LSRs in 
the treatment area allowed by the Investigator will be recorded in the Concomitant 
Medication eCRF up to Day 57. 
7.3.4.5 
Focused Dermatological Exam of Treatment Area and Standard Photography 
The focused dermatological exam of the treatment area includes evaluation of LSRs, 
pigmentation, and scarring (see Section 7.3.4.5.1 and Section 7.3.4.5.2, respectively). 
Standardized photography will be performed at the Response Assessment Visits (Days 5, 8, 
15, 29, and 57) and at additional follow-up visits after Day 57 for subjects who have 
unresolved LSRs, hypo- or hyper- pigmentation, or scarring in the treatment area (Table 1).  
See Section 7.2.6 for details. 
7.3.4.5.1 
LOCAL SKIN REACTIONS 
After the assessment of AEs at the Response Assessment Visits (Days 5, 8, 15, 29, and 57) 
(Table 1), the Investigator or Subinvestigator will assess for LSRs in the treatment area.  See 
Section 7.2.5.1 for details.  The same Investigator or Subinvestigator will conduct the LSR 
assessment at all visits for an individual subject. 
All application site reactions and LSRs will be followed to resolution, or if resolution is 
unlikely, to stabilization. 
Treatment for any LSR will be recorded on the Concomitant Medications eCRF.  
Interruption/discontinuation of study treatment for an LSR will be recorded on the eCRF. 


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7.3.4.5.2 
PIGMENTATION AND SCARRING 
Hypo- and hyper-pigmentation and scarring in the treatment area will be assessed at the 
Response Assessment Visits (Days 5, 8, 15, 29, and 57) (Table 1).  See Section 7.2.5.2 for 
details.  The same Investigator or Subinvestigator will assess pigmentation and scarring at all 
visits for an individual subject. 
7.3.4.6 
Physical Examinations  
A complete PE will be performed on Day 57 (Table 1) and will include weight and an 
assessment of the head, eyes, ears, nose, and throat (HEENT), integumentary, 
gastrointestinal, cardiovascular, respiratory, musculoskeletal, and neurological systems.  
Height will be measured at Screening only. 
Documentation of the PE will be included in the source documentation at the site(s).  
Changes from screening PE to findings at the last visit that meet the definition of an AE will 
be recorded on the Adverse Event eCRF. 
7.3.4.7 
Vital Signs 
Vital signs will also be recorded at the Response Assessment Visits on Days 5 and 57 
(Table 1).  Vital sign (pulse rate, systolic and diastolic blood pressure, respiratory rate, and 
body temperature) measurements will be taken after the subject has been seated for at least 
5 minutes.  Serial vital signs may be obtained to confirm accurate readings. 
Clinically significant abnormal vital signs, as assessed by the Investigator, will be reported as 
adverse events. 
7.3.4.8 
Electrocardiograms 
Electrocardiograms will be obtained at the Response Assessment Visits on Days 5 and 15 
(Table 1).  See Section 7.1.11 for details. 
Any ECG abnormality that the Investigator considers as an AE should be recorded as such on 
the Adverse Event eCRF. 
7.3.4.9 
Laboratory Measurements 
Blood will be collected for clinical laboratory tests at Response Assessment Visits on 
Days 8 and 15 (Table 1).  Collection of blood and urine (including samples for pregnancy 
testing, where applicable) will be conducted at the clinic site.  Approximately 8 mL of blood 
will be collected for clinical laboratory testing, including pregnancy testing, when required, 
for a total of 24 mL of blood per subject during the study.  All samples will be sent to a 
central laboratory for testing. 


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Microscopic urinalysis will be conducted only when clinically indicated based on dipstick 
results (laboratory protocol) or as determined by the Investigator.  When conducted, 
microscopic urinalysis results will be recorded on the eCRF. 
The clinical laboratory tests to be measured during the study are provided in Table 3. 
Table 3 
Clinical Laboratory Tests 
Category 
Parameters 
Hematology 
red blood cells (RBC), hemoglobin, hematocrit, platelets, and white 
blood cells (WBC) with differential (neutrophils, lymphocytes, 
monocytes, eosinophils, basophils 
Chemistry 
 
 Electrolytes 
chloride, potassium, sodium, bicarbonate (HCO3) 
 Liver function tests 
alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate 
aminotransferase (AST), direct bilirubin, total bilirubin 
 Renal function tests 
blood urea/blood urea nitrogen, creatinine 
 Other 
Albumin, calcium, cholesterol, glucose, lactate dehydrogenase (LDH), 
phosphorus, total protein, triglycerides, uric acid 
Urinalysis (dipstick) 
hydrogen ion concentration (pH), specific gravity, protein, glucose, 
ketones, leukocyte esterase, nitrite, bilirubin, urobilinogen, blood 
Pregnancy Testing 
serum pregnancy test or urine pregnancy test (see Table 1) 
 
A laboratory abnormality may meet the criteria to qualify as an AE as described in this 
protocol (see Section 7.3.4.1).  In these instances, the AE corresponding to the laboratory 
abnormality will be recorded on the Adverse Event eCRF. 
For laboratory abnormalities meeting the criteria of SAEs (see Section 7.3.4.2), the site must 
report the SAE, including the laboratory report (as regionally required), to the Sponsor using 
the SAE form (see Section 8.1). 
7.3.5 
Pregnancy Testing 
For women of childbearing potential, a serum pregnancy test will be obtained at the Response 
Assessment Visit on Day 8 and a urine pregnancy test will be performed on Day 57/early 
termination at the clinical site (Table 1).  Serum samples will be sent to a central laboratory 
for testing. 
7.4 
Additional Follow-up Assessments 
All subjects who have unresolved LSRs, hypo- or hyper-pigmentation, scarring in the 
treatment area, or treatment-related AEs at Day 57 will return for additional follow-up, which 
includes standardized photography of the treatment area, every 7 to 28 days until resolution, 
returned to baseline, or deemed stabilized by the Investigators. 


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7.5 
Recurrence Follow-up Period Assessments 
7.5.1 
Recurrence Assessments 
A dermatologist (Investigator or Subinvestigator) will perform a count of clinically visible AK 
lesions (lesion count) for subjects who achieve 100% clearance of AK lesions in the treatment 
area at Day 57 during the Recurrence Follow-up Period at the 3-, 6-, 9- and 12-month visits 
(Table 1).  The Investigator or Subinvestigator performing the lesion count should be the 
same Investigator or Subinvestigator who evaluated the subject previously during the study. 
An AK lesion should be counted if it is within the treatment area.  All AK lesions within the 
treatment area must be counted and recorded in the eCRF as an AK recurrence. 
When AK lesions are identified in the treatment area, the transparency which was used to 
map the AK lesions at Baseline should be used to determine if the lesion(s) is new (ie, one 
which was not identified in the target treatment area at Baseline and emergent during the 
Recurrence Follow-up Period) or recurred (ie, one which is at the same AK lesion location 
identified at Baseline and resolved at Day 57). 
For subjects who have complete response at Day 57 and no recurrence, 12 months 
post-Day 57 is the Final Visit.  Subjects who have AK recurrence in the treatment area will 
have their Final Visit at the visit when the AK recurrence is identified.  Subjects who develop 
AK lesions in the treatment area during the Recurrence Follow-up Period will be 
discontinued at the time of recurrence. 
7.5.2 
Safety Assessments 
During the Recurrence Follow-up Period, safety assessments will include the monitoring and 
recording of AEs and SAEs within the treatment area at the 3-, 6-, 9- and 12-month visits 
(Table 1).  See Section 7.3.4.1 for further information on the assessments of AEs.   
Concomitant medications/therapies given for AEs within the treatment area and any 
concomitant medications/therapies given that may affect assessment of AK lesions 
recurrence in the treatment area will be assessed during the Recurrence Follow-up Period at 
the 3-, 6-, 9- and 12-month visits (Table 1) and will be recorded on the Concomitant 
Medication eCRF.  The Investigator will record any AE within the treatment area on the 
Adverse Event eCRF for which the concomitant medication/therapy was administered. 
Events of special interest during the Recurrence Follow-up Period include skin cancers 
(including BCC, SCC, melanoma) within the treatment area and pregnancy.  Information on 
skin cancers will be collected during the Recurrence Follow-up Period at the 3-, 6-, 9- and 
12-month visits and reported as an event of special interest and as an AE in the Adverse 
Event eCRF (see Section 8.2.4). 


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7.6 
Appropriateness of Measurements 
All clinical assessments are standard measurements commonly used in studies of adults with 
AK. 
The safety assessments to be performed in this study, including hematology analyses, blood 
chemistry tests, urinalysis, vital signs, PEs, ECGs, and assessment of AEs, are standard 
evaluations to ensure subject safety.  The tests used to evaluate AK lesions including AK 
lesion counting, LSR grading, application site AEs, and evaluation of pigmentation and 
scarring in the treatment area are standard. 
8 
EXPEDITED REPORTING 
Serious adverse events and events of special interest (overdose of study medication, 
pregnancy, ocular exposure to study medication, and skin cancers [including BCC, SCC, and 
melanoma]) are to be reported to the Sponsor within 1 business day of the Investigator 
becoming aware of the event.  Specific forms for reporting each type of event will be 
provided to the sites. 
The Sponsor (or its designee) must inform Investigators and regulatory authorities of 
reportable events, in compliance with applicable regulatory requirements, on an expedited 
basis (ie, within specific timeframes).  For this reason, it is imperative that sites provide 
complete SAE and events of special interest information in the manner described below. 
In determining what SAEs meet criteria for expedited reporting, the current version of the 
KX2-391 Ointment Investigator’s Brochure will be used as the reference safety information 
for KX2-391 Ointment 1%. 
8.1 
Reporting of Serious Adverse Events 
All SAEs, regardless of their relationship to study treatment, must be reported on a 
completed SAE form by electronic transmission as soon as possible but no later than 
1 business day from the date the Investigator becomes aware of the event. 
Detailed contact information and SAE reporting requirements will be provided in the 
Investigator File. 
During Screening, Treatment and Response Assessment Periods, all SAEs must be reported 
beginning from the time the subject signs the study ICF, up to 30 days following the last 
contact or Day 57, whichever is shorter.  All SAEs will be reported regardless of causality. 
During the Recurrence Follow-up Period, only SAEs within the treatment area will be 
reported.  SAEs within the treatment area will be reported regardless of causality.  Once 
recurrence of AK lesions occurs in the treatment area, and the subject is discontinued from 
the Recurrence Follow-up Period, SAEs will no longer be collected.  


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Any SAE event judged by the Investigator to be related (definitely, probably, or possibly 
related) to study treatment should be reported to the Sponsor regardless of the length of time 
that has passed since study completion.  
Deaths and life-threatening events should be reported immediately by telephone.  The 
initial report must be submitted within 1 business day by electronically transmitting the 
completed SAE form. 
It is very important that the SAE Report Form be filled out as completely as possible at the 
time of the initial report.  This includes the Investigator’s assessment of causality.  All 
supporting documents should be sent de-identified and should contain the subject’s assigned 
enrollment number.  Only supporting documents directly related to the event should be sent. 
Any follow-up information received on SAEs should be forwarded as soon as possible.  If the 
follow-up information changes the Investigator’s assessment of causality, this should also be 
noted on the follow-up SAE form. 
Preliminary SAE reports should be followed as soon as possible by detailed descriptions 
including redacted copies of hospital case reports, autopsy reports, and other documents 
requested by the Sponsor. 
8.2 
Reporting of Events of Special Interest 
8.2.1 
Pregnancy 
Any pregnancy, whether occurring in a subject or in the female partner of a male subject, 
must be reported.  Pregnancies in female subjects for which the estimated date of conception 
was prior to Day 57 must be reported; pregnancies in female partners of male subjects for 
which the estimated date of conception was within 90 days of the last study treatment must 
be reported. 
The Pregnancy Report Form must be used for reporting.  Pregnancies must be reported by 
electronic transmission as soon as possible but no later than 1 business day from the date the 
Investigator becomes aware of the pregnancy.  The contact information for the reporting of 
pregnancies is provided in the Investigator File. 
If an adverse outcome of a pregnancy is suspected to be related to study drug exposure, this 
should be reported regardless of the length of time that has passed since the exposure to study 
treatment. 
A congenital anomaly, death during perinatal period, an induced abortion, or a spontaneous 
abortion are considered to be SAEs and should be reported in the same timeframe and in the 
same format as all other SAEs (see Section 8.1). 
All pregnancies must be followed to outcome.  The outcome of the pregnancy must be 
reported as soon as possible but no later than 1 business day from the date the Investigator 
becomes aware of the outcome. 


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A female subject who becomes pregnant during the Treatment Period must be withdrawn 
from study treatment, but may continue all study assessments and be followed for study 
outcome.  Male subjects whose female partners become pregnant during the Treatment 
Period may continue with study treatment and all assessments. 
A pregnant female subject should be requested to provide outcome information on any 
pregnancy occurring during the Treatment Period or the Recurrence Follow-up Period 
whether or not the subject elects to continue with study assessments.  Male subjects whose 
female partners become pregnant within 90 days of the last study treatment should be 
requested to provide outcome information on the pregnancy. 
8.2.2 
Study Drug Overdose 
Study drug overdose is defined as the accidental or intentional use of the drug in an amount 
higher than the dose being studied or for a duration longer than specified in the protocol. 
The Overdose Report Form must be used for reporting.  The overdose must be reported by 
electronic transmission as soon as possible but no later than 1 business day from the date the 
Investigator becomes aware of the event.  The contact information for the reporting of 
overdose is provided in the Investigator File.   
Any study drug overdose during the study must be noted on the eCRF. 
All AEs associated with overdose should be captured on the Overdose Report Form and the 
Adverse Event eCRF.  If the overdose is associated with an SAE, an SAE Report Form 
should be completed and sent along with the Overdose Form. 
8.2.3 
Ocular Exposure 
Ocular exposure to study medication will be reported as an event of special interest. 
The Ocular Exposure Report Form must be used for reporting.  The ocular exposure must be 
reported by electronic transmission as soon as possible but no later than 1 business day from 
the date the Investigator becomes aware of the event.  The results of an ophthalmologist’s 
assessment must be provided as a follow-up on the Ocular Exposure Report Form.  The 
contact information for the reporting of ocular exposure is provided in the Investigator File.   
Ocular exposure to study medication must be captured on the appropriate eCRF.  If the 
ocular exposure is associated with an AE, the AE must be captured on the Ocular Exposure 
Report Form and the Adverse Event eCRF.  If the ocular exposure is associated with an SAE, 
an SAE Report Form should be completed and sent along with Ocular Exposure Report 
Form. 
8.2.4 
Skin Cancer 
During the Treatment and Response Assessment Periods (Days 1 to 57), all skin cancers 
(including BCC, SCC, and melanoma) will be reported as events of special interest.  The 


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location and treatment will be reported.  During the Recurrence Follow-up Period, skin 
cancers (including BCC, SCC, and melanoma) within the treatment area will be reported as 
events of special interest.  The treatment of the skin cancer will be reported. 
The Skin Cancer Report Form must be used for reporting.  The skin cancer must be reported 
by electronic transmission as soon as possible but no later than 1 business day from the date 
the Investigator becomes aware of the event.  The contact information for the reporting of 
skin cancers is provided in the Investigator File. 
The skin cancer must be captured on the Adverse Event eCRF.  Any other AEs associated 
with the skin cancer must be captured on the Skin Cancer Report Form and the Adverse 
Event eCRF.  If the skin cancer is associated with an SAE, an SAE Report Form should be 
completed and sent along with Skin Cancer Report Form. 
8.2.5 
Breaking the Blind 
The Pharmacovigilance department will maintain a secure copy of the set of sealed 
envelopes, each containing the subject’s treatment allocation for this study.  The Investigator 
may request to unblind the treatment assignment of any subject when this is needed for 
proper medical management of a medical emergency or SAE.  Agreement of the Sponsor’s 
Medical Monitor or designee should be sought prior to unblinding.  Instructions for 
requesting unblinding of a subject will be provided in the Pharmacy Manual. 
The Pharmacovigilance department may unblind individual cases when required for safety 
reporting.  The treatment assignment will be included on the MedWatch or CIOMS form for 
suspected unexpected serious adverse reaction (SUSAR) reports provided to health 
authorities. 
9 
STATISTICAL METHODS 
9.1 
Statistical and Analytical Plans 
All statistical analyses will be performed by the Sponsor or designee after the database is 
locked and released for unblinding.  Database lock, randomization code release, and 
subsequent data analyses will be performed in 2 steps. 
For the first step, after all dosed subjects have completed the Day 57 Visit or discontinued by 
the Day 57 Visit, and after all LSRs, hypo- or hyper- pigmentation, scarring, or treatment-
related AEs which occur before or on the Day 57 Visit have resolved, returned to baseline, or 
been deemed stabilized by the Investigators, the data collected before the Recurrence Follow-
up Period will be locked and the randomization code will be released to the Sponsor only.  
The endpoint analyses, except for the recurrence rate and AEs in the treatment area after 
Day 57, will be performed. 
For the second step, after the entire study has been completed, the data collected during the 
Recurrence Follow-up Period will be locked and the randomization code will be released to 


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the study sites as well.  Then, the recurrence rate and AEs in the treatment area after Day 57 
will be analyzed. 
Statistical analyses will be performed using SAS software or other validated statistical 
software as required.  The statistical analyses of the study data are described in this section.  
Further details of the statistical analyses will be included in a separate statistical analysis plan 
(SAP), which will be written and signed off prior to unblinding of Day 57 data. 
If not specified, the baseline value of each assessment will be defined as the latest non-
missing value assessed before the first dose of study treatment. 
9.1.1 
Study Endpoints 
9.1.1.1 
Efficacy 
9.1.1.1.1 
PRIMARY ENDPOINT 
Complete (100%) clearance rate of AK lesions, defined as the proportion of subjects at 
Day 57 with no clinically visible AK lesions in the treatment area. 
9.1.1.1.2 
SECONDARY ENDPOINTS 
Key Secondary Endpoint: 
x Partial clearance rate of AK lesions, defined as the proportion of subjects at Day 57 
ZLWKDUHGXFWLRQLQWKHQXPEHURI$.OHVLRQVLGHQWLILHGDWBaseline (Day 1 
predose) in the treatment area 
Additional Endpoint: 
x Recurrence rate of AK lesions in subjects who achieved complete clearance at Day 57 
9.1.1.2 
Safety 
x Evaluation of LSRs, pigmentation and scarring in the treatment area, AEs, SAEs, 
events of special interest, clinical laboratory data, and other safety assessments (vital 
signs, PEs, ECGs) 
x AEs within the treatment area after Day 57 and up to 12 months post-Day 57 
9.1.2 
Definitions of Analysis Sets 
Intent-To-Treat (ITT) Population:  all randomized subjects.  This is the primary efficacy 
population. 
Per-Protocol (PP)/Evaluable Population:  all randomized subjects who have received at 
least 4 of the 5 doses, conformed to the protocol as to entry criteria, did not receive 
concomitant medications that can affect efficacy, and returned for the final visit on Day 57. 


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Safety Population:  all randomized subjects who have received at least one dose of study 
treatment. 
Recurrence Follow-up Population: all subjects who achieved complete clearance at 
Day 57, regardless of which treatment they received. 
9.1.3 
Subject Disposition 
All subjects will be tabulated as to study discontinuation and the reasons for discontinuation 
as described in Section 5.3. 
Discontinuations through Day 57 and during the Recurrence Follow-up Period will be 
analyzed separately. 
9.1.4 
Demographic and Other Baseline Characteristics 
Demographic and baseline characteristics will be summarized.  For continuous demographic 
variables, results will be presented as n, mean, standard deviation (SD), median, and 
minimum and maximum values.  For categorical (nominal or ordinal) variables, the number 
and percentage of subjects will be summarized for each category. 
9.1.5 
Prior and Concomitant Therapy 
All investigator terms for medications recorded in the eCRF will be coded using the WHO 
Drug Dictionary. 
Prior medications will be defined as medications/therapies taken 28 days before Day 1. 
Concomitant medications/therapies will be defined as medications/therapies that (1) started 
before the first dose of study drug and were continuing at the time of the first dose of study 
drug or (2) started on or after the date of the first dose of study drug. 
Prior and concomitant medications will be further coded to the appropriate Anatomical-
Therapeutic-Chemical (ATC) code indicating therapeutic classification.  A summary of 
concomitant medications by drug and drug class will be included in the clinical study report 
for this protocol.   
All prior and concomitant medications/therapies will be presented in subject data listings. 
9.1.6 
Efficacy Analyses 
9.1.6.1 
Primary Efficacy Endpoint Analysis 
To achieve statistical significance in the study, the Day 57 complete clearance rate will be 
analyzed using a Cochran-Mantel-Haenszel (CMH) model controlling for treatment location 
and treatment group.  Before applying the CMH method, a Breslow-Day test with a 
significance level of 10% will be used to explore heterogeneity of the odds ratios across 
treatment location subgroups. 


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Further, the Pearson Chi Square (used to power the study) will be applied to demonstrate 
basic agreement with the CMH. 
The primary efficacy analysis will be performed with the ITT population, and will be 
repeated with the PP/Evaluable population to support the primary efficacy analysis results. 
Low enrollment sites will be pooled to analysis sites with approximately 20 subjects in each 
pool. For example, the number of subjects enrolled will be graphically displayed by study 
site and treatment location (face or scalp) from the smallest number to the largest, with bars 
depicting treatment response. Then, analysis sites will be defined for approximately every 
20 subjects pooled from the study sites with the lowest enrollment. 
Another CMH test adjusting for treatment group and analysis site will be performed to ensure 
concordance with the primary efficacy endpoint analyses described above. 
To explore heterogeneity of the odds ratios across analysis sites, the Breslow-Day test at a 
significance level of 10% will be applied. A finding of statistical significance in this test will 
be followed by exploratory analyses to identify outlier study sites. 
The outlier sites will be discussed and an exploratory analysis excluding the outlier sites may 
be carried out to estimate the impact of site-by-treatment interactions. This process will be 
documented as an appendix to the final version of the SAP, prior to the first database lock. 
9.1.6.2 
Secondary Efficacy Endpoint Analyses 
Partial clearance rate will be analyzed in the same way as the primary efficacy endpoint 
(complete clearance rate).  However, to control for multiplicity, partial clearance rate as the 
key secondary efficacy endpoint will be examined using a step-down gatekeeping testing 
strategy for the overall type I error rate. In other words, the primary endpoint will serve as a 
gatekeeper for the key secondary endpoint. The complete clearance rate will be tested 
initially; if, and only if it is statistically significant at the 0.05 significance level, then the 
partial clearance rate will be statistically tested at the same significance level. 
Recurrence rates will be estimated based on a Kaplan-Meier method at each nominal post-
Day 57 visit.  Subjects with missing AK assessments in the Recurrence Follow-up Period 
will be considered as censored. 
9.1.6.3 
Additional AK Lesion Count Analysis 
The number of AK lesions and the change from baseline in lesion count at each visit will be 
summarized using descriptive statistics (ie, mean, SD, median, minimum and maximum) by 
treatment location (face or scalp) and treatment group for the ITT population. 


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9.1.6.4 
Missing Data Handling and Sensitivity Analysis 
For the primary and the key secondary efficacy endpoint analyses, all missing data caused by 
subject early discontinuation will be imputed with a last observation carried forward (LOCF) 
method.  
In addition, the following approaches will be used as sensitivity analyses for the primary and 
key secondary efficacy endpoints: 
1. Observed Cases (OC): Those subjects with missing AK lesion counts at Day 57 visit will 
be excluded from the analysis populations (ITT and PP/Evaluable) and then the primary and 
key secondary endpoint analyses described above will be repeated to show concordance. 
2. Subjects without Day 57 AK lesion counts due to early termination or other reasons will 
be considered as non-responders for complete/partial clearance rate analysis  
3. Multiple Imputation (MI): A multiple imputation method may be applied to impute 
missing values (only for the primary and key secondary efficacy variables). 
9.1.6.5 
Subgroup Analysis 
To indicate concordance with the overall results, the primary and the key secondary efficacy 
endpoints will be tabulated and displayed graphically in subgroups such as treatment location 
IDFHRUVFDOSJHQGHUDJHRU\HDUVEDVHOLQH$.OHVLRQFRXQWRUand 
skin type (Fitzpatrick I/II or III/IV/V/VI).  Outliers will be clinically explained in the clinical 
study report. 
9.1.7 
Safety Analyses 
All subjects in the Safety Analysis Set will be included in the safety analyses. 
Safety data will be summarized by treatment group using descriptive statistics (eg, n, mean, 
SD, median, minimum, maximum for continuous variables; n [%] for categorical variables).  
Safety variables include evaluation of LSRs, pigmentation and scarring in the treatment area, 
AEs, SAEs, events of special interest, clinical laboratory data, and other safety assessments 
(vital signs, PEs, ECGs). 
Safety data collected through Day 57 and during the Recurrence Follow-up Period will be 
analyzed separately. 
9.1.7.1 
Extent of Exposure 
The actual number of doses for each subject will be summarized by treatment group. 


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9.1.7.2 
Adverse Events 
For AEs, verbatim terms on the eCRF will be mapped to preferred terms (PTs) and system 
organ classes (SOCs) using the Medical Dictionary for Regulatory Activities (MedDRA) 
(version 16.0 or higher). 
All AEs, treatment-emergent or otherwise, will be presented in subject data listings.  Only 
those AEs that are treatment-emergent will be included in summary tables.   
Treatment-emergent AEs are defined as: 
x either those AEs with an onset after the first dose or  
x those pre-existing AEs that worsen after the first dose. 
TEAEs will be summarized by treatment group.  The incidence of TEAEs will be reported as 
the number (percentage) of subjects with TEAEs by MedDRA SOC and PT and treatment 
group.  A subject will be counted only once within an SOC and PT, even if the subject 
experienced more than 1 TEAE within a specific SOC and PT.  The number (percentage) of 
subjects with TEAEs will also be summarized by maximum severity (by highest mild, 
moderate or severe rating) and by relationship to study treatment.  Treatment-related TEAEs 
include those events considered by the Investigator to be related (definitely, probably, or 
possibly related) to study treatment. 
By-subject listings of all SAEs and events of special interest will be provided.  If any deaths 
occur in the study, a by-subject listing of all AEs leading to death will be provided. 
A subject data listing of all AEs leading to discontinuation from the study will be provided. 
For subjects who have treatment-related AEs at Day 57, all safety endpoints observed during 
any additional follow-up assessments will be listed. 
During the Recurrence Follow-up Period, TEAEs in the treatment area will be summarized 
separately. 
9.1.7.3 
Laboratory Values 
Laboratory parameters will be summarized using descriptive statistics at baseline and at each 
subsequent timepoint by treatment group.  Changes from baseline will also be summarized 
by treatment group.   
In addition, shift tables (ie, low-normal-high at baseline versus low-normal-high at follow-up 
in a 3-by-3 contingency table) will be provided to assess changes in laboratory values from 
baseline to Day 8 and baseline to Day 15 in each treatment group. 
All laboratory data will be listed by subject. 


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9.1.7.4 
Pregnancy Tests 
Results of pregnancy tests will be listed for all subjects, as applicable. 
9.1.7.5 
Vital Signs 
Vital sign values will be listed by subject. 
9.1.7.6 
Electrocardiograms 
All ECG data will be listed for each subject.  A by-subject listing of clinically significant 
ECG abnormality data will be provided. 
9.1.7.7 
Physical Examinations 
Physical examination findings will be listed for each subject. 
9.1.7.8 
Local Skin Reactions and Pigmentation and Scarring 
LSR, hyper- or hypo-pigmentation and scarring assessment results obtained through Day 57 
will be displayed and summarized by visit and treatment group.  In addition, a composite 
score, which is defined as the sum of 6 individual LSR scores from the same visit, will be 
analyzed in the same way. 
All LSR, hyper- or hypo-pigmentation, and scarring assessment results during any additional 
follow-ups after Day 57 will be presented in the by-subject listings. 
9.1.8 
Determination of Sample Size 
The sample size was estimated based on the primary efficacy endpoint for the comparison of 
KX2-391 Ointment 1% and vehicle control.  By using a Pearson Chi-square method, a 
sample size of 100 scalp-treated subjects and 200 face-treated subjects, both of which are 
with a 1:1 treatment allocation ratio, will give a greater than 90% power to detect a 20% 
difference (30% for active treatment and 10% for vehicle control) with a two-tailed 
significant level 0.05. 
9.1.9 
Interim Analysis 
No interim analysis is planned for this study. 
9.1.10 
Other Statistical/Analytical Issues 
Not applicable 


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9.1.11 
Procedure for Revising the Planned Analysis 
If the prespecified plans for analysis need to be revised after the study starts, the Sponsor will 
determine how the revision impacts the study and how the revision should be implemented.  
The details of the revision will be documented and described in the clinical study report. 


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10 PROCEDURES AND INSTRUCTIONS  
The Investigator will conduct the study in strict accordance with the protocol (refer to 
ICH E67, Section 4.5). 
10.1 Access to Source Data / Documents 
The Sponsor’s CRA will maintain contact with the Investigator and designated staff by 
telephone, letter, or email between study visits.  Monitoring visits to each site will be 
conducted by the assigned CRA as described in the monitoring plan.  The Investigator will 
allow the CRA to inspect the clinical, laboratory, and pharmacy facilities to assure 
compliance with GCP and local regulatory requirements.  The eCRFs and subject’s 
corresponding original medical records (source documents) are to be fully available for 
review by the Sponsor’s representatives at regular intervals.  These reviews verify adherence 
to study protocol and data accuracy in accordance with local regulations.  All records at the 
site are subject to inspection by the local auditing agency and Institutional Review Board 
(IRB) review. 
In accordance with ICH E6, Section 1.52, source documents include, but are not limited to 
the following: 
x 
Clinic, office, or hospital charts 
x 
Copies or transcribed health care provider notes which have been certified for accuracy 
after production 
x 
Recorded data from automated instruments such as x-rays, and other imaging reports, 
(eg, sonograms, CT scans, magnetic resonance images, radioactive images, ECGs, 
rhythm strips, EEGs, polysomnographs, pulmonary function tests) regardless of how 
these images are stored, including microfiche and photographic negatives 
x 
Medical history or other questionnaires completed by subjects 
x 
Records of telephone contacts 
x 
Diaries or evaluation checklists 
x 
Drug distribution and accountability logs maintained in pharmacies or by research 
personnel 
x 
Laboratory results and other laboratory test outputs (eg, urine pregnancy test result 
documentation and urine dip-sticks) 
x 
Correspondence regarding a study subject’s treatment between physicians or memoranda 
sent to the IRB 
In addition to the routine monitoring procedures, qualified personnel designated by the 
Sponsor may conduct audits of clinical research activities in accordance with the Sponsor’s 
standard operating procedures (SOPs) to evaluate compliance with the principles of ICH 
GCP and all applicable local regulations.  If a government regulatory authority requests an 


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inspection during the study or after its completion, the Investigator must inform the Sponsor 
immediately. 
10.2 Quality Control and Quality Assurance 
This study will be organized, performed, and reported in compliance with the protocol, 
SOPs, working practice documents, and applicable regulations and guidelines.  Site audits 
will be made periodically by the Sponsor’s or the CRO’s qualified compliance auditing team, 
which is an independent function from the study team responsible for conduct of the study. 
10.2.1 
Data Collection 
Data required by the protocol will be documented in the participant source documentation 
and entered into a validated electronic data capture (EDC) system. 
Responsible site personnel will enter the information required by the protocol onto the 
eCRFs in accordance with the eCRF Completion Guidelines that are provided.  A CRA will 
visit each site as documented in the monitoring plan to verify the data on eCRFs for 
completeness and accuracy against the source documents.  
The Investigator has ultimate responsibility for the collection and reporting of all clinical, 
safety, and laboratory data entered on the eCRF. 
Data that are provided by an external vendor will be transferred and validated according to 
the procedures specified in the Data Management Plan. 
All data derived from the study will be the property of the Sponsor and should not be made 
available in any form to third parties without written permission from the Sponsor, except for 
authorized representatives of the Sponsor or appropriate regulatory authorities. 
10.2.2 
Clinical Data Management 
There will be a Data Management Plan to detail all relevant data management activities, from 
eCRF design to database lock. 
Quality control for all relevant data management activities and data validation procedures 
will be applied to ensure the validity and accuracy of the clinical data. 
10.3 ETHICS 
This study will be conducted in accordance with SOPs of the Sponsor (or designee), which 
are designed to ensure adherence to GCP guidelines as required by the following: 
x 
Principles of the World Medical Association Declaration of Helsinki (2013) 
x 
ICH E6 GCP guidelines  


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x 
Title 21 of the US Code of Federal Regulations (US 21 CFR) regarding clinical studies, 
including Part 50 and Part 56 concerning informed subject consent and IRB regulations 
and applicable sections of US 21 CFR Part 312 
10.3.1 
Institutional Review Boards 
The protocol, any protocol amendments, and ICF will be reviewed and approved by an IRB 
constituted and functioning in accordance with ICH E6 (GCP), Section 3, and any local 
regulations.  Any protocol amendment and/or revision to the ICF will receive appropriate 
approval prior to implementation.  Verification of unconditional approval of the protocol will 
be transmitted to the Sponsor prior to the shipment of drug supplies to the investigational 
site.  The Investigators or the Sponsor will submit, depending on local regulations, periodic 
reports and inform the IRB of any reportable AEs per ICH guidelines and local IRB 
standards of practice. 
A signed letter of study approval from the IRB chairman must be sent to the Principal 
Investigator with a copy to the Sponsor before study start and the release of any study drug to 
the site by the Sponsor or its designee (ICH E6, Section 4.4).  If the IRB decides to suspend 
or terminate the study, the Investigator will immediately send the notice of study suspension 
or termination by the IRB to the Sponsor. 
Study progress is to be reported to IRB annually (or as required) by the Investigator or 
Sponsor, depending on local regulatory obligations.  If the Investigator is required to report 
to the IRB, he/she will forward a copy to the Sponsor at the time of each periodic report.  The 
Investigator(s) or the Sponsor will submit, depending on local regulations, periodic reports 
and inform the IRB of any reportable AEs per ICH guidelines and local IRB standards of 
practice.  Upon completion of the study, the Investigator will provide the IRB with a brief 
report of the outcome of the study, if required. 
At the end of the study, the Sponsor should notify the IRB within 90 days. 
In the case of early termination/temporary halt of the study, the Investigator should notify the 
IRB within 15 calendar days, and a detailed written explanation of the reasons for the 
termination/halt should be given. 
10.3.2 
Subject Information and Informed Consent 
As part of administering the informed consent document, the Investigator (or designee) must 
explain to each subject the nature of the study, its purpose, the procedures involved, the 
expected duration, the potential risks and benefits involved, any potential discomfort, 
potential alternative procedure(s) or course(s) of treatment available to the subject, and the 
extent of maintaining confidentiality of the subject’s records.  Each subject must be informed 
that participation in the study is voluntary, that he/she may withdraw from the study at any 
time, and that withdrawal of consent will not affect his/her subsequent medical treatment or 
relationship with the treating physician. 


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The informed consent should be given by means of a standard written statement, written in 
nontechnical language.  The subject should understand the statement before signing and 
dating it and will be given a copy of the signed document.  At the Screening Visit, after the 
ICF and any other written information to be provided is read and explained, the subject will 
be asked to sign the ICF before any study-specific procedures are performed.  No subject can 
enter the study before his/her informed consent has been obtained. 
An approved ICF must be prepared in accordance with ICH E6, and all applicable 
regulations.  Each subject must sign an approved ICF before study participation.  The form 
must be signed and dated by the appropriate parties.  The original, signed ICF for each 
subject will be verified by the Sponsor and kept on file according to local procedures at the 
site. 
The subject should be informed in a timely manner if new information becomes available 
that may be relevant to the subject’s willingness to continue participation in the study.  The 
communication of this information should be documented. 
10.4 Data Handling and Recordkeeping 
10.4.1 
Recording of Data 
An eCRF must be completed for each subject by qualified and authorized personnel.  Any 
correction to entries made on the eCRF must have a respective audit trail where the 
correction is dated, the individual making the correction is identified, the reason for the 
change is stated, and the original data are not obscured.  Only data required by the protocol 
for the purposes of the study should be collected. 
10.4.2 
Identification of Source Data 
All data to be recorded on the eCRF must reflect the corresponding source documents. 
10.4.3 
Retention of Records 
The circumstances of completion or termination of the study notwithstanding, the 
Investigator is responsible for retaining all study documents, including but not limited to the 
protocol, copies of eCRFs, the Investigator's Brochure, and regulatory agency registration 
documents, ICFs, and IRB correspondence.  In addition, the Sponsor will send a list of 
treatment codes by study subject to the Investigator after the clinical database for this study 
has been locked.  The sites should plan to retain study documents, as directed by the Sponsor, 
for at least 2 years after the last approval of a marketing application in an ICH region and 
until there are no pending or contemplated marketing applications in an ICH region or at 
least 3 years have elapsed since the formal discontinuation of clinical development of the 
investigational product. 
It is requested that at the completion of the required retention period, or should the 
Investigator retire or relocate, the Investigator contact the Sponsor, allowing the Sponsor the 
option of permanently retaining the study records. 


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10.5 Publication Policy 
The detailed obligations regarding the publication of any data, material results, or other 
information generated or created in relation to the study shall be set out in the agreement 
between each Investigator and the Sponsor or CRO, as appropriate. 
10.6 Other Administrative Policies 
10.6.1 
Changes to the Protocol 
There are to be no changes to the protocol without written approval from the Sponsor.  
Protocols will be followed as written. 
Any change to the protocol requires a written protocol amendment or administrative change 
that must be approved by the Sponsor before implementation.  Amendments specifically 
affecting the safety of subjects, the scope of the investigation, or the scientific quality of the 
study require submission to health or regulatory authorities as well as additional approval by 
the applicable IRBs.  These requirements should in no way prevent any immediate action 
from being taken by the Investigator, or by the Sponsor, in the interest of preserving the 
safety of all subjects included in the study.  If an immediate change to the protocol is felt by 
the Investigator to be necessary for safety reasons, the Sponsor’s Medical Monitor and the 
IRB for the site(s) must be notified immediately.  The Sponsor must notify the health or 
regulatory authority as required per local regulations.  A protocol change intended to 
eliminate an immediate hazard may be implemented immediately, provided the health or 
regulatory authority and IRBs are immediately notified and appropriate documentation of the 
urgent protocol change are submitted per local regulations. 
Protocol amendments that affect only administrative aspects of the study may not require 
submission to health or regulatory authority or the IRB, but the health or regulatory authority 
and IRB should be kept informed of such changes as required by local regulations.   
10.6.2 
Disclosure and Confidentiality 
The contents of this protocol and any amendments and results obtained during the study 
should be kept confidential by the Investigator, the Investigator’s staff, and the IRB, and will 
not be disclosed in whole or in part to others, or used for any purpose other than reviewing or 
performing the study, without the written consent of the Sponsor.  No data collected as part 
of this study will be used in any written work, including publications, without the written 
consent of the Sponsor.  These obligations of confidentiality and non-use shall in no way 
diminish such obligations as set forth in either the Confidentiality Agreement or Clinical 
Trial Agreement executed between the Sponsor/CRO and the institution/Investigator. 
All persons assisting in the performance of this study must be bound by the obligations of 
confidentiality and non-use set forth in either the Confidentiality Agreement or Clinical Trial 
Agreement executed between the institution/Investigator and the Sponsor/CRO. 


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10.6.3 
Discontinuation of Study 
The Sponsor reserves the right to discontinue the study for medical reasons or any other 
reason at any time.  If a study is prematurely terminated or suspended, the Sponsor will 
promptly inform the Investigators/institutions and regulatory authorities of the termination or 
suspension and the reason(s) for the termination or suspension.  The IRB will also be 
informed promptly and provided the reason(s) for the termination or suspension by the 
Sponsor or by the Investigator/institution, as specified by the applicable regulatory 
requirement(s). 
The Investigator reserves the right to discontinue the study should his/her judgment so 
dictate.  If the Investigator terminates or suspends a study without prior agreement of the 
Sponsor, the Investigator should inform the institution where applicable, and the 
Investigator/institution should promptly inform the Sponsor and the IRB and provide them 
with a detailed written explanation of the termination or suspension.  Study records must be 
retained as noted above. 


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11 REFERENCE LIST 
1. Marks R, Rennie G, Selwood TS.  Malignant transformation of solar keratoses to 
squamous cell carcinoma.  Lancet 1988;1(8589):795-7. 
2. Criscione VD, Weinstock MA, Naylor MF, et al. Actinic keratoses: natural history 
and risk of malignant transformation in the Veterans Affairs Topical Tretinoin 
Chemoprevention Trial. Cancer 2009;115(11):2523-30. 
3. Glogau RG. The risk of progression to invasive disease. J Am Acad Dermatol 
2000;42(1 Pt 2):23-4. 
4. Salasche SJ. Epidemiology of actinic keratoses and squamous cell carcinoma. J Am 
Acad Dermatol 2000;42(1 Pt 2):4-7. 
5. Guidelines for the Management of Actinic Keratoses.  2004/2005 European 
Dermatology Forum.  Available from: http://www.euroderm.org  [Accessed 02 July 
2012]. 
6. Drake LA, Ceilley RI, Cornelison RL, et al. Guidelines of care for actinic keratoses. 
Committee on Guidelines of Care. J Am Acad Dermatol 1995;32(1):95-8. 
7. ICH E6: Guidance for Industry - E6 Good Clinical Practice: Consolidated Guidance, 
US Department of Health and Human Services, Food and Drug Administration, April 
1996. 
8. Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through IV. 
Arch Dermatol 1998;124(6):869-71. 
9. Draft 
Guidance 
on 
ingenol 
mebutate, 
January 
2016.  
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/G
uidances/UCM481827.pdf 
 


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12 APPENDICES 
 
 


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Confidential 
Page 68 of 71 
 
 
APPENDIX 1 INSTRUCTIONS FOR SUBJECTS’ SELF-
ADMINISTRATION OF STUDY TREATMENT  
The study kit contains: 
x 5 packets filled with study drug, inside individual plastic bags  
x A dosing log 
Storage: 
Store the study kit at room temperature and in a secure place, out of direct sunlight, and away 
from food products, children, and pets. 
Patient Instructions: 
Application of study drug is preferably done early in the day and at approximately the same 
time every day for a total of 5 days.  The first dose will be self-administered in the clinic. 
Follow these steps to apply study drug: 
x Take the dosing log in the study kit and record the date and time of dosing. 
x Open the plastic bag and remove a single-dose packet. 
x Tear the packet open along the perforations. 
x Squeeze a small amount of ointment from the packet on your fingertip and apply it 
evenly over the entire treatment area (Note:  Each packet contains more than the 
amount needed for 1 treatment application.). 
x Place the used packet (including torn pieces) into the plastic bag in which it came, 
seal the plastic bag, and put it back into the study kit. 
x Wash hands immediately with water and soap. 
x Place the dosing log back into the study kit and store away the study kit, as instructed 
above, in a secure place. 
x Repeat the above steps for each day of treatment at about the same time each day. 
x On Day 5, apply treatment before returning to clinic.  Bring the study kit (containing 
all used and unused packets) and the dosing log with you. 
 
 


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Confidential 
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Precautions on Treatment Days (Days 1-5): 
x Subjects who wear contact lenses should put on their contact lenses BEFORE 
applying study drug. 
x Avoid touching or wetting the treatment area for approximately 12 hours.  If you 
touch the treatment area, wash your hands immediately. 
x Avoid activities that might cause excessive sweating, so that the ointment will not get 
in your eyes. 
x If ointment does get into your eyes, flush your eyes with water immediately and 
extensively.  You must immediately contact the study doctor who will give you 
further instructions.  You will be referred to an eye doctor so your eyes can be 
examined. 
x If any severe local skin reaction occurs or persists, let your study doctor know 
immediately. 
x Do not apply study drug more than once each day. 
x Do not allow other people or pets to come into contact with the treatment area.  If the 
treatment area is touched, the area of contact on the other person or pet should be 
washed immediately. 
x Do not cover the treatment area with bandages, band aids, tight-fitting scarfs, or caps. 
Precautions Throughout the Study: 
x When washing the treatment area, wash it gently with a mild, non-abrasive, non-
medicated soap or shampoo. 
x Do not expose the treatment area to excessive sun light or ultraviolet light, including 
tanning beds.  When outdoors, wear protective loose clothing over the treatment area.  
x Do not use moisturizers, sunscreen, artificial tanners, make-up or other over the 
counter-topical products to the study treatment area until Day 57.  If you are unsure of 
what to use, ask your study doctor.  After 15 days, if you are unable to avoid 
excessive sun light or ultraviolet light to the treatment area, the study doctor may 
allow you to use sunblock.  
x Do not use medications not approved by your study doctor. 
x After Day 57, sunblock and non-medicated topical products can be used in the 
treatment area. 
 






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SAP_001.pdf: 
Statistical Analysis Plan 
Protocol: KX01-AK-004 
 
 
Athenex   
V3.0_04 Jun 2019 
Confidential 
 
 
Page 1 of 33 
 
 
 
 
 
 
 
STATISTICAL ANALYSIS PLAN 
 
Study Protocol Number: 
KX01-AK-004 
Study Protocol Title: 
A 
Phase 
3, 
Double-Blind, 
Vehicle-Controlled, 
Randomized, Parallel Group, Multicenter, Efficacy and 
Safety Study of KX2-391 Ointment 1% in Adult Subjects 
with Actinic Keratosis on the Face or Scalp 
Date: 
04 Jun 2019 
Version: 
3.0 (Amendement 02) 
 
 
 
 
 
 
 
 
 
 
 
 


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