Clinical trial NCT04720105
Conditions: Palmoplantar Psoriasis Plaque Psoriasis
Keywords: Palmoplantar Psoriasis Plaque
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2020-11-19; Completion date: 2022-03-29
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to examine the effect of Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ) on plaque type psoriasis of the hands and/or feet.

Detailed description:
Plaque type psoriasis of the hands and/or feet affects approximately 3-4% of patients with psoriasis. It is characterized by well-defined erythematous desquamative plaques located on the palms and soles, which may be limited to acral involvement or occur in combination with generalized psoriasis. Psoriasis that affects the hands and/or feet has a profound impact on quality of life (QoL) as it contributes to more physical disability and discomfort than patients with other forms of psoriasis, such as difficulty walking or using the hands.

Furthermore, psoriasis of the hands and/or feet is generally considered a therapeutic challenge because the thicker stratum corneum reduces the penetration of topical treatment agents. Systemic treatments (retinoids, psoralen-ultraviolet A \[PUVA\], methotrexate, cyclosporine, and biologic therapy) have shown limited efficacy on psoriasis in acral areas. Unfortunately, patients with hand and/or foot involvement often have too low of body surface area (BSA) to participate in clinical trials for new psoriasis treatments, resulting in limited studies among this sub-population and no clear treatment algorithm.

The high unmet need for an effective treatment for psoriasis of the hands and/or feet has been addressed in recent years with the development of new medications for generalized psoriasis that may also be effective in treating disease localized to acral areas. In 2015, two multicenter, double-blind, randomized, parallel-group phase 3 studies were conducted to assess the safety, tolerability, and efficacy of lotion containing a combination of halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ). The study population was subjects with moderate-to-severe psoriasis. The study results found that treatment success (defined as at least a 2-grade improvement from baseline Investigator Global Assessment score and a score of clear or almost clear) was achieved in around 40% of subjects by week 8, with substantial reductions in affected BSA, improvement in QoL, and a significant reduction in signs and symptoms of psoriasis.

These phase 3 studies did not include a sub-analysis of the effect of HP/TAZ on psoriasis of the hands and/or feet. Given that topical steroids and topical retinoids are separately recommended as treatment options for psoriasis of the hands and/or feet, an agent that safely combines these medications - and that has demonstrated safety and efficacy in generalized psoriasis - offers a potential treatment for psoriasis of the hands and/or feet.

The purpose of the study described in this protocol is to evaluate the effect of HP/TAZ on plaque type psoriasis of the hands and/or feet after 24 weeks of daily treatment. In addition, given the impact of this variant of psoriasis on QoL and the relative lack of currently available treatment options, this study will also evaluate the impact of HP/TAZ treatment on patient-reported QoL measures and treatment satisfaction scoring.

Arms: arm 1: Participants with plaque type psoriasis to be treated with Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion) to be applied thinly once a day on the affected areas of hands and/or feet.
Interventions: intervention 1: Duobrii®
Intervention descriptions: intervention 1: Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ) will be provided at weeks 0,2,8,16 for a total of 24 weeks.

Protocol documents:
Prot_SAP_000.pdf: 
Investigator-Initiated, Open Label Trial of a Combination of Halobetasol Propionate 0.01% 
Andtazarotene 0.045% Lotion (Duobrii®) for Plaque Type Psoriasis of the Hands and/or 
Feet
PI: Alice Gottlieb, MD, PhD
NCT04720105
Document Date: Nov 30, 2020


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Clinical Research Protocol 
 
Investigator-Initiated, Open Label Trial of a combination of halobetasol propionate 0.01% and 
tazarotene 0.045% lotion (Duobrii®) for Plaque Type Psoriasis of the Hands and/or Feet 
 
 
 
Version Date 
November 30, 2020 
(supersedes version date March 31, 2020) 
Investigational 
Product 
Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion) 
Sponsor 
Ortho Dermatologics 
Principal 
Investigator 
Alice Gottlieb, MD, PhD 
Mount Sinai Downtown Union Square 
 
212-844-8800 
a lice.gottlieb@mountsinai.org 
 


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Table of Contents 
Protocol Synopsis 
3 
Brief Summary of Research 
8 
Background 
8 
Setting of Human Research 
9 
Study Objectives 
10 
Study Design 
10 
Criteria for Evaluation 
12 
Subject Selection 
13 
Concomitant Therapies 
13 
Study Treatments 
14 
Study Procedures & Guidelines 
14 
Adverse Events and Reporting 
16 
Protocol Violations 
17 
Statistical Methods & Considerations 
18 
Data Collection, Retention, & Monitoring 
18 
Ethical & Regulatory Considerations 
19 
References 
20 
Figure 1: Patient-Reported Outcomes instrument 
21 
Figure 2: Treatment Satisfaction instrument 
23 
Appendix 1: Evaluation Schedule 
24 


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Protocol Synopsis 
 
 
Title 
Investigator-initiated, Open Label Trial of 
Duobrii® for Plaque Type Psoriasis of the 
Hands and/or Feet 
Sponsor 
Ortho Dermatologics 
Study Design & Overview 
This is an investigator-initiated, 
single-arm, open-label study, which will 
examine the effect of Duobrii® 
(halobetasol propionate 0.01%/tazarotene 
0.045% lotion, HP/TAZ) on plaque type 
psoriasis of the hands and/or feet. 
Previous therapies used and failed will be 
captured for each subject. The findings in 
this study will result in at least one poster 
at a conference and at least one 
publication. 
Primary Objective 
Evaluate the percentage of patients 
achieving Palmoplantar Physician Global 
Assessment (ppPGA) of 0 (clear) or 1 
(almost clear/minimal) after 24 weeks of 
treatment1 
Secondary Objectives 
● Percentage of patients achieving 
ppPGA of 0 or 1 at weeks 8, 12 
and 16 
● Photography (hands and/or feet 
only) to assess treatment response 
at weeks 0, 2, 8, 12, 16 and 24 
● Patient-reported outcomes to be 
evaluated by Dermatology Quality 
of Life Index (DLQI)2 at weeks 2, 8, 
12, 16 and 24 


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● Treatment satisfaction to be 
evaluated by Numerical Rating 
Scale (NRS)3 at weeks 2, 8, 12, 16 
and 24 
Number of Subjects 
22 
Subject Selection Criteria 
Inclusion Criteria 
1. Subject is able to provide written, 
informed consent and comply with 
the study protocol. 
2. Subject is at least 18 years of age. 
3. Subject has a diagnosis of 
plaque-type palmar and/or plantar 
psoriasis. 
4. Patient has at least one psoriatic 
plaque outside of the palms and 
soles or psoriatic nail findings. 
5. Subject has a ppPGA ≥ 3 at 
screening/baseline visit. 
6. Subject is using adequate birth 
control during the study period as 
defined as follows: 
○ Option 1: Any one of the 
following highly effective 
methods: hormonal 
contraception (oral, 
injection, implant, 
transdermal patch, vaginal 
ring); intrauterine device 
(IUD); tubal ligation; or 
partner’s vasectomy; 
OR 
○ Option 2: Male or female 
condom (latex condom or 
non-latex condom NOT 


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made out of natural [animal] 
membrane [for example, 
polyurethane]; PLUS one 
additional barrier method: 
(a) diaphragm with 
spermicide; (b) cervical cap 
with spermicide; or (c) 
contraceptive sponge with 
spermicide. 
OR 
1. Option 3: Abstinence from sex 
when it is a lifestyle choice, and 
not just a social circumstance. 
Exclusion Criteria 
1.  Subject is not able to provide 
written, informed consent and 
comply with the study protocol. 
2. Subject is less than 18 years of 
age. 
3. Subject has non-plaque type 
psoriasis on the hands and/or feet. 
4. Patient does not have any evidence 
of psoriasis elsewhere. 
5. Subject has concurrent cutaneous 
disease affecting the hands and/or 
feet that would interfere with 
assessments. 
6. Subject has a ppPGA < 3 at 
screening/baseline visit. 
7. Subject refuses to discontinue 
concomitant prescription 
medications on hands and/or feet. 
8. Subject has used prescription 
topical treatments or received 
phototherapy treatment for 
psoriasis within 2 weeks of 
screening/baseline visit. 


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9. Subject has used intralesional 
kenalog within 4 weeks of 
screening/baseline visit. 
10. Subject has taken oral treatments 
for psoriasis within 4 weeks of 
screening/baseline visit. 
11. Subject has received any 
treatment with biologic 
medications within 5 half-lives (if 
known) or 16 weeks prior to 
screening/baseline, whichever is 
longer. 
12. Subject refuses to use adequate 
birth control during the duration 
of the study period. 
13. Subject is currently pregnant or 
breastfeeding. 


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Study Treatment 
Duobrii® (halobetasol propionate 
0.01%/tazarotene 0.045% lotion), thin 
layer applied to affected areas of palms 
and/or soles once a day 
Study Duration 
The total duration of study activities is 24 
weeks 
Schedule of Efficacy and Safety 
Assessments 
Screening/Baseline (Week 0), Week 2, 
 Week 8, Week 12, Week 16, 
Week 24 
Laboratory Work 
None 
Safety Evaluations 
Safety and tolerability will be assessed by 
adverse events, physical examinations 
(including skin examinations and ppPGA 
scoring), and concomitant medication 
review 
Statistical Analysis 
Assuming the 40% of patients achieve 
ppPGA of 0 or 1 (similar to that seen with 
secukinumab) at week 24, this study 
requires 22 patients with a statistical 
power of 0.8 and 5% type one error 
Budget Estimate 
$120,845 
88 tubes of Duobrii® (4 tubes of Duobrii® 
for each subject) supplied by Ortho 
Dermatologics. 
The medication will be dispensed to 
the subject at week 0,2,8,16 and 
returned by the 


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subject at week 2,8,16,24. 
Subjects will be compensated $40 per 
study visit for their time and effort in 
participating in this study. 


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  Brief Summary of Research 
The purpose of this research study is to examine the effect of Duobrii® (halobetasol 
propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ) on plaque type psoriasis of the 
hands and/or feet. It is an investigator-initiated, single-arm, open-label study that will 
include 22 subjects. A thin layer of HP/TAZ will be applied to affected areas of palms 
and/or soles once a day. Treatment response will be clinically evaluated using the 
Palmoplantar Physician Global Assessment (ppPGA), which is a 5-point scale specifically 
applied to the hands and/or feet: 0 (clear), 1 (almost clear/minimal), 2 (mild), 3 (moderate), 
4 (marked/moderate-to-severe), 5 (severe). The primary objective of the study is to 
evaluate the percentage of subjects achieving ppPGA of 0 or 1 after 24 weeks of 
treatment. Secondary objectives include evaluation of treatment response at earlier 
timepoints (Weeks 2, 8, 12,16 and 24), including serial photography (also taken at week 
0), patient-reported outcomes, and treatment satisfaction evaluation throughout the study 
period. In addition, safety and tolerability will be assessed by physical exam findings, 
adverse event monitoring, and concomitant medication review. Previous therapies used 
and failed will be captured for each subject. 
 
Background 
Plaque type psoriasis of the hands and/or feet affects approximately 3-4% of patients with 
psoriasis.4 It is characterized by well-defined erythematous desquamative plaques 
located on the palms and soles, which may be limited to acral involvement or occur in 
combination with generalized psoriasis.5 Psoriasis that affects the hands and/or feet has 
a profound impact on quality of life (QoL) as it contributes to more physical disability and 
discomfort than patients with other forms of psoriasis, such as difficulty walking or using 
the hands.1,6 
 
Furthermore, psoriasis of the hands and/or feet is generally considered a therapeutic 
challenge because the thicker stratum corneum reduces the penetration of topical 
treatment agents. Systemic treatments (retinoids, psoralen–ultraviolet A [PUVA], 
methotrexate, cyclosporine, and biologic therapy) have shown limited efficacy on 
psoriasis in acral areas.5 Unfortunately, patients with hand and/or foot involvement often 
have too low of body surface area (BSA) to participate in clinical trials for new psoriasis 


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treatments, resulting in limited studies among this sub-population and no clear treatment 
algorithm.1 
 
The high unmet need for an effective treatment for psoriasis of the hands and/or feet has 
been addressed in recent years with the development of new medications for generalized 
psoriasis that may also be effective in treating disease localized to acral areas. In 2015, 
two multicenter, double-blind, randomized, parallel-group phase 3 studies were 
conducted to assess the safety, tolerability, and efficacy of lotion containing a combination 
of halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ).7,8 The study 
population was subjects with moderate-to-severe psoriasis. The study results found that 
treatment success (defined as at least a 2-grade improvement from baseline Investigator 
Global Assessment score and a score of clear or almost clear) was achieved in around 
40% of subjects by week 8, with substantial reductions in affected BSA, improvement in 
QoL, and a significant reduction in signs and symptoms of psoriasis.7,8 
 
These phase 3 studies did not include a sub-analysis of the effect of HP/TAZ on psoriasis 
of the hands and/or feet. Given that topical steroids and topical retinoids are separately 
recommended as treatment options for psoriasis of the hands and/or feet, an agent that 
safely combines these medications – and that has demonstrated safety and efficacy in 
generalized psoriasis – offers a potential treatment for psoriasis of the hands and/or feet. 
 
The purpose of the study described in this protocol is to evaluate the effect of HP/TAZ on 
plaque type psoriasis of the hands and/or feet after 24 weeks of daily treatment. In 
addition, given the impact of this variant of psoriasis on QoL and the relative lack of 
currently available treatment options, this study will also evaluate the impact of HP/TAZ 
treatment on patient-reported QoL measures and treatment satisfaction scoring. 
 
Setting of Human Research 
 
All research related activities will take place at Mount Sinai Downtown Department of 
Dermatology located at 10 Union Square E, New York, NY. 


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Study Objectives 
Research Question: What is the effect of Duobrii® (halobetasol propionate 
0.01%/tazarotene 0.045% lotion, HP/TAZ) on plaque type psoriasis of the hands and/or 
feet? 
 
This study will evaluate the hypothesis that HP/TAZ can improve plaque type psoriasis of 
the hands and/or feet. The purpose is to evaluate the effect of once daily treatment with 
HP/TAZ for 24 weeks among 22 subjects. Treatment response will be evaluated using 
the Palmoplantar Physician Global Assessment (ppPGA) 5-point scale.1 The primary 
objective is to determine what percentage of subjects achieve a ppPGA of 0 (clear) or 1 
(almost clear/minimal) after 24 weeks of treatment. 
 
Study Design 
The study aims to enroll 22 subjects at a single study site. This number assumes that 
40% of subjects with plaque type psoriasis of the hands and/or feet will achieve a ppPGA 
of 0 or 1 (based on results seen with secukinumab) at week 24. Based on this, the study 
requires 22 patients to achieve a statistical power of 0.8 and 5% type one error. Based 
on retrospective data of similar studies conducted at this site, recruitment and enrollment 
of 22 subjects is feasible and expected to be completed in 12 months. 
 
The study staff includes individuals who are experienced in conducting research and have 
comprehensive knowledge of the study population, culture, and society. This is a single-
site study, so no management of information among sites will be necessary to protect 
subjects. This study is not classified as Community-Based Participatory Research. 
Given that it is a single-arm, open-label study, there will be no randomization. 
Study Timeline: 
● An individual subject will participate in study activities for a total of 24 weeks from 
initial screening/baseline visit at Week 0 to the final study visit at Week 24. 
● It is anticipated that it will take up to 12 months to enroll all study subjects. 


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● It is estimated that this study will be completed, including completion of primary 
analyses, by the end of 2022. 
 
Potential subjects will be screened for eligibility based on the inclusion and exclusion 
criteria indicated below. 
 
Inclusion Criteria 
 
1. Subject is able to provide written, informed consent and comply with the study 
protocol. 
2. Subject is at least 18 years of age. 
3. Subject has a diagnosis of plaque-type palmar and/or plantar psoriasis. 
4. Patient has at least one psoriatic plaque outside of the palms and soles or 
psoriatic nail findings. 
5. Subject has a ppPGA ≥ 3 at screening/baseline visit. 
6. Subject is using adequate birth control during the study period as defined as 
follows: 
a. Option 1: Any one of the following highly effective methods: hormonal 
contraception (oral, injection, implant, transdermal patch, vaginal ring); 
intrauterine device (IUD); tubal ligation; or partner’s vasectomy; 
OR 
b. Option 2: Male  or female condom (latex condom or nonlatex condom  NOT 
made out of natural [animal] membrane [for example, polyurethane]; PLUS 
one additional barrier method: (a) diaphragm with spermicide; (b) cervical 
cap with spermicide; or (c) contraceptive sponge with spermicide. 
OR 
c. Option 3: Abstinence from sex when it is a lifestyle choice, and not just a 
social circumstance. 
 
Exclusion Criteria 
 
1. Subject is not able to provide written, informed consent and comply with the 
study protocol. 
2. Subject is less than 18 years of age. 
3. Subject has non-plaque type psoriasis on the hands and/or feet. 
4. Patient does not have any evidence of psoriasis elsewhere. 


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5. Subject has concurrent cutaneous disease affecting the hands and/or feet that 
would interfere with assessments. 
6. Subject has a ppPGA < 3 at screening/baseline visit. 
7. Subject refuses to discontinue concomitant prescription medications on hands 
and/or feet. 
8. Subject has used topical prescription treatments or received phototherapy 
treatment for psoriasis within 2 weeks of screening/baseline visit. 
9.   Subject has used intralesional kenalog within 4 weeks of screening/baseline 
visit. 
10. Subject has taken oral treatments for psoriasis within 4 weeks of 
screening/baseline visit. 
11. Subject has received any treatment with biologic medications within 5 half-lives (if 
known) or 16 weeks prior to screening/baseline, whichever is longer. 
12. Subject refuses to use adequate birth control during the duration of the study 
period. 
13. Subject is currently pregnant or breastfeeding. 
 
Criteria for Evaluation 
The primary endpoint of this study is an individual subject achieving Palmoplantar 
Physician Global Assessment (ppPGA) of 0 (clear) or 1 (almost clear/minimal) after 24 
weeks of treatment. The ppPGA is based on the Investigators Global Assessment (IGA) 
modified version 11, specifically applied to the hands and/or feet: 0 (clear), 1 (almost 
clear/minimal), 2 (mild), 3 (moderate), 4 (marked/moderate-to-severe), 5 (severe). 1 
 
The secondary endpoints of this study include the following: 
● Percentage of patients achieving ppPGA of 0 or 1 at weeks 8, 12 and 16 
● Photography (hands and/or feet only) to assess treatment response at weeks 0, 
2, 8, 12, 16 and 24 
● Patient-reported outcomes evaluated by Dermatology Quality of Life Index 
(DLQI)2 to be determined at weeks 2, 8, 12, 16 and 24 
● Treatment satisfaction evaluated by a Numerical Rating Scale (NRS)3 to be 
determined at weeks  2, 8, 12, 16 and 24 
 
The DLQI is a 10 question dermatology-specific quality of life questionnaire covering the 
following topics: symptoms, embarrassment, shopping and home care, clothes, social 
and leisure, sport, work or study, close relationships, sex, treatment. Each question refers 


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to the impact of the skin disease on the patient’s life over the previous week.2 


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The NRS for treatment satisfaction consists of 1 question: “Consider all the good and bad 
things about this treatment. Overall, how satisfied are you with the treatment?” Answer 
options: -3 (very dissatisfied), -2 (moderately satisfied), -1 (mildly satisfied), 1 (mildly 
satisfied), 2 (moderately satisfied), 3 (very satisfied). 
 
There are no anticipated primary or secondary safety endpoints that would cause a study 
subject’s participation to end due to safety. 
 
Subject Selection 
Potential subjects will be recruited from routine clinical appointments at Mount Sinai 
dermatology clinics as well as Mount Sinai-affiliated dermatologists and other referring 
dermatologists. 
 
Concomitant Therapies 
All concomitant therapies must be recorded throughout the study period, from 
Screening/Baseline through Week 24. Subjects will be asked about concomitant 
therapies as part of the review of medical history at every study visit. With respect to 
specific classes of concomitant therapies: 
● Topical therapies: Topical therapies that could affect the ppPGA evaluations (eg, 
corticosteroids, 
tar, 
anthralin, 
calcipotriene, 
tazarotene, 
methoxsalen, 
pimecrolimus, tacrolimus) are not permitted. The only allowable concomitant 
treatments throughout the study are non-medicated topical moisturizers. However, 
subjects should not use non-medicated topical moisturizers on the day of a study 
visit. 
● Phototherapy: The use of phototherapy is not permitted at any time during the 
study. 
● Systemic therapy: The use of systemic psoriasis medications is not permitted at 
any time during the study. These medications include those targeted for reducing 
TNF (including but not limited to infliximab or etanercept), drugs targeted for 
reducing IL-12, IL-17, or IL-23 (including but not limited to ustekinumab, 
tildrakizumab, secukinumab, ixekizumab, or brodalumab), alpha-4 integrin 
antagonists (including but not limited to natalizumab), systemic steroids, any 
conventional systemic therapy that could affect ppPGA evaluation (including but 


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not limited to methotrexate, cyclosporine, acitretin), and any other biological agent 
or other systemic medication that could affect the ppPGA evaluation. 
● Other therapies: Every effort should be made to keep subjects on stable frequency 
and dosing of concomitant medications for general medical conditions. Such 
medications should be recorded at Week 0 (Screening/Baseline Visit) and if any 
changes to frequency or dosing are made during the duration of the study, such 
changes should be reported by the patient and recorded in the source documents. 
 
Study Treatments 
Upon enrollment in the study, each subject will be given a supply of HP/TAZ at visits 
0,2,8,16 to be used over the 24 weeks. Each subject will be instructed to apply a thin 
layer HP/TAZ to affected areas of palms and/or soles once a day for the duration of the 
study (i.e. daily treatment for 24 weeks). 
 
All study treatments will be completed by the subject and will occur in the home setting. 
Subjects will be encouraged to record and report any missed treatments. Patients will be 
allowed to use OTC moisturizers, but should not apply them the days of their visits. 
 
Study Procedures & Guidelines 
The study is designed to include six study visits over 24 weeks. The procedures 
performed at each study visit are detailed below. All procedures will be performed at the 
single study site. They will also be instructed to store the investigational drug at 20 to 25 
°C (68 to 77 °F), and to not freeze the drug. 
 
A table detailing the study procedures is found in Appendix 1. All study visits and 
procedures will be documented in source documents created specifically for this study 
that will be completed in accordance with Good Clinical Practice (GP) documentation 
principles (i.e. attributable, legible, contemporaneous, original, accurate, enduring, 
available and accessible, complete, consistent, credible, and corroborated9). 
 
I. 
Week 0 (Screening/Baseline) 
A. Review Inclusion/Exclusion criteria 
B. Obtain written informed consent 
C. Review medical history and previous failed therapies 


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D. Review concomitant medications 
E. Perform physical examination 
F. Obtain urine pregnancy test (for pre-menopausal female subjects only) 
G. Evaluate ppPGA 
H. Obtain photographs of affected areas 
I. Dispense study drug 
II. 
Week 2 
A. Review adverse events 
B. Review concomitant medications 
C. Evaluate ppPGA 
D. Administer DQLI 
E. Administer NRS for treatment satisfaction 
F. Obtain photographs of affected areas 
G. Dispense study drug 
H. Collect study drug 
III. 
Week 8 
A. Review adverse events 
B. Review concomitant medications 
C. Evaluate ppPGA 
D. Administer DQLI 
E. Administer NRS for treatment satisfaction 
F. Obtain photographs of affected areas 
G. Dispense study drug 
H. Collect study drug 
IV. 
Week 12 
A. Review adverse events 
B. Review concomitant medications 
C. Evaluate ppPGA 
D. Administer DQLI 
E. Administer NRS for treatment satisfaction 
F. Obtain photographs of affected areas 
V. 
Week 16 
A. Review adverse events 
B. Review concomitant medications 
C. Evaluate ppPGA 
D. Administer DQLI 


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E. Administer NRS for treatment satisfaction 
F. Obtain photographs of affected areas 
G. Dispense study drug 
H. Collect study drug 
VI. 
Week 24 
A. Review adverse events 
B. Review concomitant medications 
C. Evaluate ppPGA 
D. Administer DQLI 
E. Administer NRS for treatment satisfaction 
F. Obtain photographs of affected areas 
G. Collect study drug 
VII. 
Early Termination 
A. Review adverse events 
B. Review concomitant medications 
C. Evaluate ppPGA 
D. Administer DQLI 
E. Administer NRS for treatment satisfaction 
F. Obtain photographs of affected areas 
G. Collect study drug  
H. Physical examination 
 
 
 
 
 
Adverse Effects and Reporting 
Safety information obtained across two Phase 3 clinical trials of HP/TAZ5,6 include the 
following risks: 
 
● The most common adverse reactions are contact dermatitis (7%), application site 
pain (3%), folliculitis (2%), skin atrophy (2%), and excoriation (2%). No serious 
treatment-related AEs were reported but would include severe hypersensitivity 
reactions and anaphylaxis. 
● HP/TAZ contains tazarotene, which is a teratogenic substance. Therefore, HP/TAZ 
is contraindicated in pregnancy and in this study, all pre-menopausal female 
subjects must have a negative pregnancy test before enrolling. 


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● HP/TAZ contains halobetasol propionate, which is a steroid. Therefore, reversible 
hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the 
potential for glucocorticosteroid insufficiency during or after treatment. Systemic 
effects of topical corticosteroids may also include Cushing's syndrome, 
hyperglycemia, and glucosuria. Systemic absorption may require evaluation for 
HPA axis suppression. Use of potent corticosteroids on large areas, for prolonged 
durations, under occlusive dressings, or on an altered skin barrier may increase 
systemic exposure. In addition, the use of topical corticosteroids may increase the 
risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma 
have been reported postmarketing with the use of topical corticosteroid products. 
Advise patients to report any visual symptoms and consider referral to an 
ophthalmologist for evaluation. 
● Some individuals may experience atrophy, striae, telangiectasias, and folliculitis at 
the application site. If these effects occur, discontinue until the integrity of the skin 
has been restored. Duobrii® should not be used on eczematous skin, as it may 
cause severe irritation. 
● HPT/TAZ can cause photosensitivity and increase the risk of sunburn. Avoid 
exposure to sunlight, sunlamps, and weather extremes. 
● Skin infections 
 
Unexpected fatal or serious adverse events will be reported to the IRB as soon as 
possible and no later than 7 calendar days after receipt of the information. Any other 
unanticipated adverse events will be reported no later than 14 days of receipt of the 
information. 
 
Pregnancies occurring during the study will be reported no later than 7 days of receipt of information 
and subjects will subsequently be withdraw


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Protocol Violations 
Subjects may withdraw from the trial at any time at their request (verbal or written), or 
they may be withdrawn at any time at the discretion of the Sponsor, PI, or designee for 
safety, behavioral, or administrative reasons. Subjects may be withdrawn from this study 
without their consent if the research study is being stopped; or if the instructions of the 
study team have not been followed. 
 
Any enrolled subject who will not be completing the duration of the study will be asked to 
complete an Early Termination study visit, consisting of the procedures indicated below. 
In addition, the reason for Early Termination will be recorded in the source documents. 
 
1) Review medical history 
2) Review concomitant medications 
3) Perform physical examination 
4) Obtain urine pregnancy test (for pre-menopausal female subjects only) 
5) Evaluate ppPGA 
6) Administer DQLI 


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7) Administer NRS for treatment satisfaction 
8) Obtain photographs of affected areas 
 
If a subject is unable or unwilling to complete an Early Termination visit, this will be 
documented in the source documents. 
 
Statistical Methods & Considerations 
Assuming the 40% of patients achieve ppPGA of 0 or 1 (similar to that seen with 
secukinumab) at week 24, this study requires 22 patients with a statistical power of 0.8 
and 5% type one error. 
 
Post-trial statistics of the data will be assessed by an individual that’s not part of the study 
staff. 
 
Data Collection, Retention, & Monitoring 
Data collected during this study will include: patient demographic information, past 
medical history, adverse events, concomitant medication, physical exam findings, urine 
pregnancy test results (for pre-menopausal female subjects only), ppPGA evaluations, 
DLQI evaluations, NRS for treatment satisfaction evaluations, and serial photography of 
affected areas. These data will be stored on-site, with the source documents in a secure, 
locked physical location and the electronic data in a password-protected format. 
 
Access to this data will be limited to study staff. All study staff will be trained on how to 
maintain the security of the data via limited authorization of access, password protection, 
encryption, physical controls, and separation of identifiers and data. 
 
This data will be stored on-site for a minimum of 10 years following completion of all study 
activities. 


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Ethical & Regulatory Considerations 
Consent process: Consent discussions will occur in a private setting. The consent 
process will be initiated well in advance to ensure that subjects have sufficient opportunity 
to consider participation. 
 
The consent process will be enforced per SOP HRP-090 Informed Consent Process for 
Research. Individuals listed in the application are authorized to obtain consent. However, 
to minimize undue influence and to allocate ample time for discussion, the consent 
responsibility will be delegated to the dermatology clinical trial research team. 
No children (i.e. subjects under the age of 18) or cognitively impaired adults (i.e. adults 
who may be unable to consent) will be enrolled in this study. 
 
Consent of the subjects will be documented in writing per the standard PPHS consent 
template. 
 
Sharing of results: Results of this study will not be shared with subjects or others who 
are not directly involved in the study (e.g. subjects’ primary care physicians). 
 
Specimen banking: No specimens will be banked in association with this study. 
 
External IRB Review History: This protocol has not been previously submitted to an 
external IRB. 
 
Control of drugs: The investigational drug will be stored at 20 to 25 °C (68 to 77 °F) in 
a secure, locked on-site location that is accessible only by authorized investigators 
involved in the study. 
 
Publication of study findings: The findings in this study will result in at least one poster 
at a conference and at least one publication. 


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References 
1. 
Gottlieb A, Sullivan J, van Doorn M, et al. Secukinumab shows significant efficacy in 
palmoplantar psoriasis: Results from GESTURE, a randomized controlled trial. J Am Acad 
Dermatol. 2017;76(1):70-80. 
2. 
Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure 
for routine clinical use. Clin Exp Dermatol. 1994;19(3):210-216. 
3. 
Salame N PCL, Singh S, Garg KA, Gottlieb AB, Latella J, Merola, JF, Armstrong AW. In. 
Washington, DC: International Dermatology Outcome Measures (IDEOM) Annual 
Meeting; 2019. 
4. 
Engin B, Askin O, Tuzun Y. Palmoplantar psoriasis. Clin Dermatol. 2017;35(1):19-27. 
5. 
Raposo I, Torres T. Palmoplantar Psoriasis and Palmoplantar Pustulosis: Current 
Treatment and Future Prospects. Am J Clin Dermatol. 2016;17(4):349-358. 
6. 
Pettey AA, Balkrishnan R, Rapp SR, Fleischer AB, Feldman SR. Patients with 
palmoplantar psoriasis have more physical disability and discomfort than patients with 
other forms of psoriasis: implications for clinical practice. J Am Acad Dermatol. 
2003;49(2):271-275. 
7. 
Gold LS, Lebwohl MG, Sugarman JL, et al. Safety and efficacy of a fixed combination of 
halobetasol and tazarotene in the treatment of moderate-to-severe plaque psoriasis: 
Results of 2 phase 3 randomized controlled trials. J Am Acad Dermatol. 2018;79(2):287-
293. 
8. 
Sugarman JL, Weiss J, Tanghetti EA, et al. Safety and Efficacy of a Fixed Combination 
Halobetasol and Tazarotene Lotion in the Treatment of Moderate-to-Severe Plaque 
Psoriasis: A Pooled Analysis of Two Phase 3 Studies. J Drugs Dermatol. 2018;17(8):855-
861. 
9. 
Bargaje C. Good documentation practice in clinical research. Perspect Clin Res. 
2011;2(2):59-63. 


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Figure 1: Patient-Reported Outcomes instrument 
 
D ERMATOLOGY LIFE QUALITY INDEX (DLQI) 
 
The aim of this questionnaire is to measure how much your skin problem has affected your life OVER THE LAST WEEK. 
Please check one box for each question. 
 
1. 
Over the last week, how itchy, sore, painful or stinging has your 
skin been? 
Very much 
☐ 
A lot 
☐ 
A little 
☐ 
Not at all 
☐ 
2. 
Over the last week, how embarrassed or self conscious have you 
been because of your skin? 
Very much 
☐ 
A lot 
☐ 
A little 
☐ 
Not at all 
☐ 
3. 
Over the last week, how much has your skin interfered with you 
going shopping or looking after your home or yard? 
Very much 
☐ 
A lot 
☐ 
A little 
☐ 
Not at all 
☐ 
Not relevant ☐ 
4. 
Over the last week, how much has your skin influenced the 
clothes you wear? 
Very much 
☐ 
A lot 
☐ 
A little 
☐ 
Not at all 
☐ 
Not relevant ☐ 
5. 
Over the last week, how much has your skin affected any social 
or leisure activities? 
Very much 
☐ 
A lot 
☐ 
A little 
☐ 
Not at all 
☐ 
Not relevant ☐ 
6. 
Over the last week, how much has your skin made it difficult for 
you to do any sport? 
Very much 
☐ 
A lot 
☐ 
A little 
☐ 
Not at all 
☐ 
Not relevant ☐ 


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7. 
Over the last week, has your skin prevented you from working or 
studying? 
yes 
no 
☐ 
☐ 
Not relevant ☐ 
If "No", over the last week how much has your skin been a problem 
at work or studying? 
A lot 
A little 
Not at all 
☐ 
☐ 
☐ 
8. 
Over the last week, how much has your skin created problems with 
your partner or any of your close friends or relatives? 
Very much 
☐ 
A lot 
☐ 
A little 
☐ 
Not at all 
☐ 
Not relevant ☐ 
9. 
Over the last week, how much has your skin caused any sexual 
difficulties? 
Very much 
☐ 
A lot 
☐ 
A little 
☐ 
Not at all 
☐ 
Not relevant ☐ 
10. 
Over the last week, how much of a problem has the treatment for 
your skin been, for example by making your home messy, or by 
taking up time? 
Very much 
☐ 
A lot 
☐ 
A little 
☐ 
Not at all 
☐ 
Not relevant ☐ 
 
Please check you have answered EVERY question. Thank you. 
 
S ource: Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp D 
ermatol. 1994;19(3):210-216. 


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Figure 2: Treatment Satisfaction instrument 
 
N UMERICAL RATING SCALE (NRS) FOR TREATMENT SATISFACTION 
Consider all the good and bad things about this treatment. Overall, how satisfied are you with the treatment? 
(circle one) 
 
-3 
Very dissatisfied 
 
-2 
Moderately dissatisfied 
 
-1 
Mildly dissatisfied 
 
1 
Mildly satisfied 
 
2 
Moderately satisfied 
 
3 
Very satisfied 
 
 
S ource: Salame N, Perez-Chada LM, Singh S, Garg KA, Gottlieb AB, Latella J, Merola, JF, Armstrong AW. International D 
ermatology Outcome Measures (IDEOM) Annual Meeting. Washington, DC. May 2019. 


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Appendix 1: Evaluation Schedule 
 
Visit 
Wk 0 
Screening/ 
Baseline 
Wk 2 
Wk 8 
Wk 12 
Wk 16 
Wk 24/ 
Early 
Termina
tion 
Inclusion/Exclusion 
criteria 
X 
Informed consent 
X 
Review medical 
history, including 
previous and 
concomitant therapies 
X 
 
 
 
 
 
 
Adverse events 
X 
X 
X 
X 
X 
 
Review con meds 
X 
X 
X 
X 
X 
X 
 
Physical 
examination 
X 
          X** 
 
Urine pregnancy test* 
X 
ppPGA 
X 
X 
X 
X 
X 
X 
 
DLQI 
X 
X 
X 
X 
X 
 
NRS for treatment 
satisfaction 
X 
X 
X 
X 
X 
 
Photography 
X 
X 
X 
X 
X 
X 
             
 
Dispense drug 
X 
X 
X 
 
X 
 
Collect Drug 
 
X 
X 
 
X 
X 
*Urine pregnancy test is required for pre-menopausal female subjects only. 
 
 
 
 
                                       
**Physical examination is only required for early termination 
ppPGA: Palmoplantar Physician Global Assessment is based on the Investigators Global Assessment (IGA) modified version 2011, specifically applied to the palms 
and soles and consisting of a 5-point scale: 0 (clear), 1 (almost clear/minimal), 2 (mild), 3 (moderate), 4 (marked/moderate-to-severe), 5 (severe). 
DLQI: Dermatology Quality of Life Index is a 10 question dermatology-specific quality of life questionnaire. 
NRS for treatment satisfaction: Numerical Rating Scale consisting of 1 question: “Consider all the good and bad things about this treatment. Overall, how satisfied 
are you with the treatment?” Answer options: -3 (very dissatisfied), -2 (moderately satisfied), -1 (mildly satisfied), 1 (mildly satisfied), 2 (moderately satisfied), 3 (very 
satisfied)