Clinical Evaluation of the Sun Protection Factor (SPF) of Sunscreen Products According to the FDA Final Rule: Sunscreen Drug Products (2011)
Phase: NA
Conditions: Sunscreening Agents
Sponsor: HALEON

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 Protocol Number: 
GSKCH Protocol Number: 
218003 
Title: 
Clinical Evaluation of the Sun Protection Factor (SPF) of 
Sunscreen Products According to the FDA Final Rule: 
Sunscreen Drug Products (2011).  
Objective:   
To measure the static SPF of three over-the-counter 
(OTC) sunscreen lip balms. 
Test Products: 
ChapStick Lip Moisturizer (CLM) Original (
) 
CLM Mint Flavour (
) 
CLM Black Cherry Flavour (
) 
Participants:         
Eligible male and female volunteers, aged 18-70 with 
Fitzpatrick skin types I, II or III will be enrolled.   
SPF Standard: 
7% Padimate-O and 3% Oxybenzone 
Sponsor: 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 
(GSK CH), 184 Liberty Corner Rd., Warren, NJ 07059 
Name: 
Phone: 
Title: Senior Clinical Study Manager 
Email:
Contract Site: 
Principal Investigator 
(PI): 
Institutional Review 
Board (IRB): 
Advarra IRB 
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Holdings (US) LLC (GSK CH)  
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Contents 
1.0 Introduction ............................................................................................................................... 4 
2.0 Objective .................................................................................................................................... 4 
3.0 Test Products ............................................................................................................................ 4 
4.0 Study Design/Blinding ............................................................................................................. 4 
5.0 Participants ................................................................................................................................ 5 
5.1 Inclusion Criteria ............................................................................................................... 6 
5.2 Exclusion Criteria .............................................................................................................. 6 
5.3 Participant Responsibilities .............................................................................................. 8 
5.4 Participant Discontinuation and Withdrawal .............................................................. 10 
5.5 Disposition of Withdrawn Participants ........................................................................ 10 
5.6 Participant Replacement ................................................................................................ 10 
6.0 Study Instruments ................................................................................................................. 10 
6.1 Solar Simulators and Radiometer/Detector systems ............................................... 10 
6.2 Colorimeter....................................................................................................................... 12 
6.3 Digital Camera ................................................................................................................. 13 
7.0 Study Procedures ................................................................................................................... 13 
7.1 Day 1..................................................................................................................................... 14 
7.1.1 
Enrollment ............................................................................................................... 14 
7.1.1.1 Informed Consent Process ..................................................................................... 14 
7.1.1.2 ITA/Skin type determination ................................................................................. 14 
7.1.2 
Initial Unprotected MED (MEDuI) Dose Administration .................................. 15 
7.2 
Day 2 .................................................................................................................................. 16 
7.2.1 
MEDuI Determination ............................................................................................ 16 
7.2.2 
Application of Study Treatments ......................................................................... 17 
7.2.2.1 SPF Standard Application ....................................................................................... 17 
7.2.2.2 Test Product Application ......................................................................................... 17 
7.2.4 UV Doses for Unprotected and Protected Sites ..................................................... 17 
7.2.4.1 Repeat Unprotected Minimal Erythema Dose (MEDuR) Determination ......... 17 
7.2.4.2 Protected Minimal Erythema Dose (tpMEDp/ssMEDp) Determination ........... 18 
7.3 Day 3..................................................................................................................................... 18 
7.3.1 
MEDuR, ssMEDp and tpMEDp Determination .................................................... 18 
8.0 Statistical Analysis ................................................................................................................. 19 
8.3 SPF Computation .................................................................................................................... 19 
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9.0 Rejected Test Data: ............................................................................................................... 20 
9.1 Invalid Data ............................................................................................................................. 20 
9.2 Other Reasons for Data Rejection ....................................................................................... 20 
10.0 Adverse Events ..................................................................................................................... 21 
10.1 Definition of an Adverse Event (AE) ......................................................................... 21 
10.3 Expected Events ............................................................................................................ 24 
11.0 Data Recording and Study Record Maintenance ............................................................ 32 
12.0 Ethical Review ...................................................................................................................... 32 
15.0 Clinical Study Report (CSR) ............................................................................................... 33 
16.0 Quality Control and Quality Assurance ............................................................................ 34 
17.0 Medical Oversight ................................................................................................................ 34 
18.0 Clinical Study Products ....................................................................................................... 35 
19.0 Record Retention ................................................................................................................. 35 
20.0 Participant Confidentiality .................................................................................................. 35 
21.0 Indemnification .................................................................................................................... 35 
22.0 Communication and Publication of Results ..................................................................... 35 
23.0 Protocol Approvals ............................................................................................................... 37 
24.0 References ............................................................................................................................. 37 
 
 
Key Abbreviations: 
MED 
Minimal Erythema Dose 
MEDu 
Unprotected MED (i.e., the MED of an untreated site) 
MEDuI 
Initial Unprotected MED 
MEDuR 
Repeat Unprotected MED 
MEDp 
Protected MED (i.e., the MED of a treated site) 
ssMEDp 
‘SPF Standard’ Protected MED (i.e., site treated with SPF standard) 
tpMEDp 
‘Test Product’ Protected MED (i.e., site treated with test product) 
ssSPFi 
SPF value for the ‘SPF standard’ for an individual participant 
tpSPFi 
SPF value for a ‘test product’ for an individual participant 
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Holdings (US) LLC (GSK CH)  
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1.0 Introduction 
The 2011 FDA Final Rule [1] describes the procedures for determining the static sun 
protection factor (SPF)of over-the-counter (OTC) sunscreen products. 
 
The static SPF is defined as the ratio of the minimal erythema dose of ultraviolet (UV) 
radiation for sunscreen-protected skin to that for unprotected skin.  The minimal 
erythema dose (MED) is the lowest dose of UV radiation that produces the first 
perceptible erythema with clearly defined borders (covering more than 50%  
of the exposure site), 16 to 24 hours (hrs) after UV exposure administration.  UV 
radiation doses, expressed in Joules/square meter (J/m2), are administered using a 
xenon arc lamp that simulates solar radiation and satisfies the requirements of the FDA 
Final Rule [1]. 
 
 
2.0 Objective 
The objective of this study is to determine the static SPF of three sunscreen products 
using the methodology described in the FDA Final Rule (2011) [1]. 
 
 
3.0 Test Products 
Three sunscreen lip balms will be evaluated; each has a target SPF of 15. 
• ChapStick Lip Moisturizer Original (
; cocoa butter fragrance) 
• ChapStick Lip Moisturizer Mint Flavour (
) 
• ChapStick Lip Moisturizer Black Cherry Flavour (
)  
 
An SPF Standard (7% Padimate-O and 3% Oxybenzone) will be evaluated alongside 
the three test products. 
 
4.0 Study Design/Blinding 
Test treatments (SPF standard, test products and unprotected sites) will be randomized 
to test sites to ensure blinded evaluation of erythemal response. Eligible participants 
will be assigned to treatment based on the randomization schedule on Day 1 of the 
study. 
   
To maintain study blinding and avoid bias, the erythema evaluator will not participate 
in either product application or the administration of UV doses. Treatment application 
and UV irradiation will be carried out by different individuals on the study team. 
 
Each participant will have up to 8 test sites delineated on the skin of their back. One 
will be used on Day 1 to determine MEDuI. Assignment of the three test products, SPF 
standard and an unprotected site (MEDuR) to test site shall follow the randomization 
schedule generated by 
 according to SOP 
. If the back of a participant 
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cannot accommodate a minimum of 6 sites (too small, unsuitable areas of anatomical 
curvature), the participant will be discontinued. 
 
Note: A minimum of 6 test sites is required to evaluate MEDuI, MEDuR, the 3 test 
products and the SPF standard sunscreen. Up to 8 test sites will be drawn to provide an 
additional 2 sites should test product reapplication be necessary due to uneven/ 
inconsistent application to help ensure UV exposures can be completed for all study 
treatments. 
 
For practical reasons, the only site that may be known to the erythema evaluator is the 
Initial Unprotected MED (MEDuI) site.  If the evaluator has questions about test site 
locations and/or exposure site locations, the evaluator may receive assistance from the 
technicians who applied the test materials and administered the UV doses; the 
technicians should not influence the evaluator in the grading of UV responses. 
 
Study duration is expected to be 3-8 days. 
 
5.0 Participants 
Potential study participants will be recruited from 
 Volunteer Database per SOPs 
. 
 
The FDA Final Rule (2011) [1] requires the test panel to produce a minimum of 10 valid 
test results for each product tested; invalid data from a maximum of 3 participants per 
product may be rejected (i.e., 10–13 participants and ≥ 10 valid results per product). 
Therefore, a maximum of 23 participants will be enrolled in order to achieve the 
minimum of 10 valid results per study product required for SPF labeling [1].  
 
Study participants will be healthy male and female volunteers with skin types I, II or 
III (Table 1: Fitzpatrick Skin Types). Individual Typology Angle (ITA°) will be measured 
for each participant to determine skin type. No discrimination of any kind (e.g. social 
class, gender, skin color, ethnicity) should preclude eligible participants from 
participating in the study.  
 
Table 1. Fitzpatrick Skin Types 
ITA Value 
Skin Color 
Categories 
Fitzpatrick 
Skin Type 
Fitzpatrick Definitions 
>55° 
Very Light 
I 
Always burns easily; never tans 
>41° to 55° 
Light 
II 
Always burns easily; tans minimally 
>28° to 41° 
Intermediate 
III 
Burns moderately; tans gradually 
>10° to 28° 
Tan 
IV 
Burns minimally; always tans well 
>-30° to 10° 
Brown 
V 
Rarely burns; tans profusely 
≤-30° 
Black 
VI 
Never burns; deeply pigmented 
 
Eligible participants must satisfy the following inclusion and exclusion criteria.  
 
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5.1 Inclusion Criteria 
• Participant must provide a signed and dated, legally effective, informed consent 
document, which indicates they have been informed of all pertinent aspects of the 
study, before any study procedures are performed. 
• Participant must be 18-70 years old inclusive at the time of consent. 
• Participant must provide relevant details of their medical history and current/recent 
medications and treatments (self-reported). 
• Participant must have completed an annual Health Insurance Portability and 
Accountability Act (HIPAA) Authorization form.  
• Participant must have completed a Photo Release Form.  
• Participant must be able to read, write, speak and understand English. 
• Participant must be in good general health. 
• Participant must have uniform skin color over the test area (skin of the back 
between the shoulder blades and above the waistline) and an ITA value >28°. 
• Participant must have Fitzpatrick Skin Type I, II or III 
• Participant must have sufficient area of suitable skin on their back for at least six 
40cm2 test sites. 
• Willing to have body hair clipped by a technician if participant has excessive hair in 
the test area. 
• Participant must have a valid form of personal identification (photo ID, driver’s 
license, passport, permanent resident card, military ID card; forms cannot be 
expired). 
• Male and female participants of child-bearing potential must agree to use a highly 
effective method of contraception for the duration of the study and for 14 days after 
their last treatment application.  
Note: A participant is considered to be of child-bearing potential if, in the opinion of the PI, they are biologically capable of 
having children and sexually active. 
 
5.2 Exclusion Criteria 
• Participant with a scheduled or planned Covid-19 vaccination during likely dates of 
study participation. 
• Participant with a history of abnormal response to sunlight/UV radiation. 
• Participant with a history of sensitivity to any ingredient of the test material or skin 
marker pen, or to latex; or any known sensitivities/allergies, including but not 
limited to cosmetic/toiletry products and topically applied skin treatment 
products/drugs. 
• Participant with any significant dermatological condition, such as atopic dermatitis 
(eczema), psoriasis, skin cancer, melanoma, active dermal lesions, nevi, blemishes 
or moles, lupus, diabetes, or connective tissue disease, that would increase the risk 
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associated with participation. 
Note: presence of non-dysplastic nevi, blemishes, or moles would be acceptable if, in the opinion of the PI, they will neither 
jeopardize participant safety or compromise study outcomes. A participant with dysplastic nevi should be disqualified. 
• Participant receiving any treatment with medications that would, in the opinion of 
the PI, confound study outcomes or increase the risk associated with participation, 
such as systemic or topical corticosteroids, antibiotics, anti-inflammatory drugs, 
antihistamines, antihypertension medications, or any other photosensitive 
medications.  
Note: The prohibited medication list will be available to site staff for reference during screening. 
• Participant who has used topical or systemic steroids, antihistamines, antibiotics or 
anti-inflammatory medications within 7 days of Study Day 1 which, in the opinion of 
the PI, could interfere with study outcomes. 
• Participant who has used/applied any personal care products (e.g. lotions, 
sunscreens, sunless tanners) and/or topical medications in/on the test area within 
24 hrs of Study Day 1. 
• Participant who is unwilling to cease use of personal care products (e.g. lotions, 
sunscreens, sunless tanners) and/or topical medications in/on the test area for the 
duration of the study. 
• Participant with any known communicable disease(s) (e.g. HIV, STD’s, Hepatitis B, 
Hepatitis C, etc.) 
• Participant with skeletal protrusions and/or extreme areas of curvature in the test 
area.  
• Participant with a medical treatment/vaccination (other than the Covid-19 
vaccination) planned during the study, which would make them ineligible, place 
them at undue risk, or confound the outcome of the study, per the discretion of the 
PI.  
• Participant who has undergone any surgical procedure in the last 12 months. 
• Participant who has undergone chemical or physical treatment procedures in the test 
area within the last 12 months. 
• Planned hospitalization during the study. 
• Participant who exceeds a weight limit of 300 pounds due to equipment limitations.  
• Participant with any condition that might confound the study results, increase the 
risk associated with participation, or interfere with study participation. 
• Female participant who is pregnant, planning to become pregnant during the study, 
or breastfeeding (self-reported). 
• Participant with any visible sunburn or suntan in test area. 
• Participant with visible sun damage, scarring or tattoos in the test area that would 
interfere with study participation.   
• Participant with any sun exposure and/or use of an artificial tanning lamp on the test 
area within 2 months of Study Day 1. 
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• Participant who is unwilling to avoid sun exposure and/or cease use of an artificial 
tanning lamp on the test area for the duration of the study. 
• Participant who has participated in any clinical study involving UV exposure within 
the last 2 months, or any other type of clinical study within the last 1 month. 
• Participant who is an employee/contractor or immediate family member of the PI, 
study site or Sponsor.  
 
5.3 Participant Responsibilities 
Lifestyle Considerations: 
For the duration of the study, participants should be 
• Dependable, willing and able to keep all study appointments, and follow study 
instructions. 
• Willing to not begin another other clinical study while participating in current study. 
• Willing to wear loose-fitting clothing to facilitate access to the back during study 
visits. 
• Willing to continue with use of their current personal care products and avoid use of 
any new personal care products (e.g. makeup, cleanser). 
• Willing to cease use of any personal care products (e.g. lotions, sunscreens, sunless 
tanners) and topical medications on the test area.   
• Willing to not use tanning lamps and to not expose the test area to the sun. 
• Willing to inform study staff about any side effects, changes in their 
health/medications, pregnancy and study-related problems.   
 
Contraception: 
All male participants able to father children and female participants who are of child-
bearing potential, sexually active and at risk of pregnancy must agree to use a highly 
effective method of contraception, consistently and correctly, for the duration of the 
study and for 14 days after their last assigned treatment. This requirement does not 
apply to females of child-bearing potential with same sex partners or to participants 
who are, and will continue to be, abstinent from penile-vaginal intercourse on a long 
term and persistent basis, when this is their preferred and usual lifestyle.  
 
The PI, or designee, will discuss the need to use highly effective contraception, 
consistently and correctly, with the participant; the conversation will be documented. 
In addition, the PI, or designee, will instruct the participant to call the site immediately 
if their contraception method is discontinued or if pregnancy is known, or suspected, in 
either the participant or the participant’s partner.  
 
The following is an all-inclusive list of female contraceptive methods that meet the GSK 
definition of highly effective for avoiding pregnancy (i.e., have a failure rate of less 
than 1 % per year when used consistently and correctly and, when applicable, in 
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accordance with the product label). Periodic abstinence (e.g., calendar, ovulation, 
sympto-thermal, post-ovulation methods) and withdrawal are not acceptable methods 
of contraception.  
 
• Contraceptive subdermal implant  
• Intrauterine device or intrauterine system 
• Combined estrogen and progestogen oral contraceptive  
• Injectable progestogen  
• Contraceptive vaginal ring  
• Percutaneous contraceptive patches  
• Male partner sterilization with documentation of azoospermia prior to the female 
participant's entry into the trial, and this male is the sole partner of the female 
participant. The documentation on male sterility can come from site personnel 
review of medical records, medical examination and/or semen analysis, or 
medical history interview provided by her or her partner.  
 
Male participants with female partners of child-bearing potential must comply with the 
following contraception requirements for the duration of the study and for 14 days after 
their last assigned test treatment. 
  
• Vasectomy with documentation of azoospermia. The documentation on male 
sterility can come from site personnel: review of the participant’s medical 
records, medical examination and/or semen analysis, or medical history 
interview.  
• Male condom plus partner use of one of the contraceptive options below that 
meets the effectiveness criteria including a less than 1% rate of failure per year, 
as stated in the product label: 
- 
Contraceptive subdermal implant  
- 
IUD or intrauterine system  
- 
Combined estrogen and progestogen oral contraceptive  
- 
Injectable progestogen  
- 
Contraceptive vaginal ring  
- 
Percutaneous contraceptive patches  
 
These allowed methods of contraception are only effective when used consistently, 
correctly and in accordance with the product label. The PI, or designee, will confirm the 
participant has had instruction in how to properly use their method of contraception 
from an appropriately trained health care professional and will document this 
conversation. 
 
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5.4 Participant Discontinuation and Withdrawal 
A participant may be discontinued or withdraw from study participation at any time if 
the participant or the PI (or designee) feels it is not in their best interest to continue. 
The following is a list of possible reasons for study discontinuation. 
 
• Participant develops a condition listed in the exclusion criteria or hypersensitivity, or 
takes a contra-indicated medication/treatment. 
• Non-compliance with the requirements of the protocol. 
• Failure to follow site staff instructions. 
• Failure to attend scheduled study visits. 
• Adverse event (AE) that, in the opinion of the PI, means it would be in the 
participant’s best interest to discontinue study participation. 
• Protocol violation requiring documentation of deviation. 
• Sponsor request for early termination of study. 
 
Participants are free to withdraw from study participation at any time, for any reason, 
specified or unspecified, and without prejudice. Reasonable attempts will be made by 
the PI, or designee, to ascertain the reason for withdrawal. This will be recorded in 
source documentation and included in the final report. 
 
5.5 Disposition of Withdrawn Participants  
The date a participant is withdrawn from the study and the reason for discontinuation 
will be recorded in source documentation. If a participant fails to return for scheduled 
study visits, the PI, or designee, will make every reasonable effort to contact the 
participant and determine why they failed to attend. This information will be recorded 
in source documentation. When a participant is withdrawn (regardless of reason), the 
PI, or designee, will encourage the participant to return to site to complete all 
evaluations which may be necessary to assure that the participant is free of untoward 
effects, and to seek appropriate follow-up for any unresolved AEs. 
 
5.6 Participant Replacement  
If participants are discontinued from the study or have their data rejected because 
results are considered invalid (see Section 9.0), additional participants can be 
randomized up to a maximum of 20 randomized participants per test product, until the 
maximum number of invalid data sets (3 per test product) is reached.  Any valid data 
collected up to that point will continue to be used.  
 
 
6.0 Study Instruments  
6.1 Solar Simulators and Radiometer/Detector systems  
The solar simulators used in the study will comprise a multiport or single port xenon 
arc lamp equipped with 1 mm WG320 UVC blocking filters, 1 mm UG-11 visible and 
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infrared blocking filters, and heat-rejecting dichroic mirrors that comply with the 2011 
FDA Final Rule [1] (Model 16S/Model 601, Solar Light Co., Philadelphia), as described 
in Table 2.  Solar simulator systems will not be interchanged or replaced during testing 
(Model 16S to Model 601 or vice versa), except in case of malfunction. 
• The Model 16S solar simulator will be used with radiometer PMA2100 and 
detector Erythema PMA2105 showing output in MED/hr. 
• The Model 601 solar simulator will be used with radiometer DCS-2/PMA2100 and 
detector Erythema PMA2108 showing output in MED/hr.  
 
 
 
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Table 2. Requirements for Irradiation Source 
Each solar simulator will have a minimum warm up time of 20 minutes 
(mins) prior to capturing the lamp effective irradiance readings.  
Continuous, stable emission spectrum from 290 to 400 nanometers (nm). 
Emission spectrum measured at least annually, after replacement of lamp 
bulb or following any change in optical components, using an appropriate 
spectroradiometer system calibrated to a NIST traceable source. 
Daily radiation intensity will be measured (after warm-up period) before and 
after each photo-test, or at least at the beginning and end of each test day, 
using an erythemally-weighted radiometer (add model) with a calibration 
consistent with the spectroradiometer system. 
No significant time-related fluctuations in the exposure plane (±10%) 
Good beam uniformity (±20% from centerline reading) 
UVAII (320-340 nm): ≥ 20% of total UV irradiance 
UVAI (340-400 nm): ≥ 60% of total UV irradiance 
Total Irradiance from 250 to 1,400 nm ≤1,500 Watts/square meter (W/m2) 
to avoid inducing excessive heat and/or pain during irradiation 
Specification of spectral output is described by the cumulative erythemal 
effectiveness for successive wavelength bands from 290-400 nm (expressed 
as a percentage of total erythemal effectiveness from less than 290 nm to 
400 nm). Percent erythemal dose contributions are provided in Table 3 
 
 
Table 3. Percent Erythemal Dose Contributions 
Wavelength 
Range (nm) 
Percent Erythemal 
Dose Contribution 
<290 
<0.1 
290-300 
1.0-8.0 
290-310 
49.0-65.0 
290-320 
85.0-90.0 
290-330 
91.5-95.5 
290-340 
94.0-97.0 
290-400 
99.9-100.0 
 
6.2 Colorimeter  
A hand-held reflectance colorimeter, SmartProbe 400 (IMS, Inc.) or equivalent, will be 
used to measure the skin color of the test site in the L*a*b* color space.  L*, a*, and 
b* values will be measured from at least 3 different locations on the participant’s back 
and used to calculate the ITA°. ITA° can be used to estimate the MED of unprotected 
sites (MEDu).[2]  
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6.3 Digital Camera  
Photographs may be taken of test sites using a Canfield Twin Flash Clinical System 
950029 with Nikon D90 Digital SLR (or similar system) to document unexpected 
results/AEs if requested by the PI, or designee, or the Sponsor. Photographs will not 
reveal participant identity. 
 
7.0 Study Procedures 
Table 4. Study Procedures 
Study Procedures 
Day 
1 
Day 
2 
Day 
3 
Written Informed Consent 
X 
  
  
Skin examination; determine ITA°; confirm skin type 
X 
 
 
Complete medical history/eligibility questionnaire 
X 
  
  
Identify and document concomitant medications/treatments 
X 
X 
X 
Confirm qualification against inclusion/exclusion criteria 
X 
 
 
Delineate 6 test sites on the skin of the back 
X 
 
 
Administer UV doses* to unprotected site for MEDuI 
X 
  
  
Assess compliance 
 
X 
X 
Evaluate UV responses (16-24 hours [hrs] later) 
Determine MEDuI 
 
X 
 
Apply test materials (SPF standard & test products) to their 
assigned test sites according to the randomization schedule 
  
X 
  
15 min drying time 
  
X 
  
Administer UV doses* to unprotected site for MEDuR 
 
X 
 
Administer UV doses* to protected sites  
  
X 
  
Evaluate UV responses (16-24 hrs later) 
Determine MEDuR and ssMEDp/tpMEDp  
  
  
X 
Monitor for Adverse Events† 
X 
X 
X 
Study conclusion 
 
 
X 
 
* For unprotected (untreated) sites, total exposure time is typically 1-2 mins; for protected sites (i.e. 
treated with either a sunscreen product or SPF standard), total exposure time is typically 11-25 mins. 
Participants will be informed of this in the ICF. 
†Adverse Events (AEs) and therefore all Serious Adverse Events (SAEs will be collected from 
immediately after participant provides consent to participate in the study by the completion of the 
Informed Consent Form (ICF). 
 
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For consistency of evaluation, study procedures (skin assessments, irradiation, 
treatment applications) will be performed with the participant in the same position – 
upright or prone – throughout the study. Test material preparation/application, UV 
exposures and MED assessments will be performed by trained study staff in ambient 
conditions (as described in SOP 
). 
 
7.1 Day 1 
7.1.1 Enrollment 
7.1.1.1 Informed Consent Process 
Written informed consent will be obtained from each potential participant prior to 
entering the study (Informed Consent of Human Subjects, 21 CFR Part 50, Subpart B). 
The PI will ensure the informed consent process is conducted in accordance with 
applicable local, state, and federal laws and regulations. 
 
Prospective participants will report to the study site and be provided with a copy of the 
Informed Consent Form (ICF), with Privacy Rule 45 CFR parts 160 and 164 (details the 
Federal protection for the privacy of health information), a Photo Release Form and an 
annual HIPAA authorization form to review. Site staff will answer any questions they 
may have about the study. If they chose to participate, site staff will obtain the 
applicable signatures on the enrollment documentation, starting with the ICF. Site staff 
will then complete a Medical History/Eligibility Questionnaire with the participant and 
document any concomitant medications/treatments (year of birth, but not full date of 
birth, may be recorded in source documentation). Enrollment procedures will be 
completed in a private setting. Each participant will be given a signed copy of the 
Informed Consent Form. If the participant has questions about their rights, they may 
contact the IRB at any time during or after trial participation. 
 
If required, site staff may consult the study physician/dermatologist regarding the 
participant’s medications/treatments and/or responses to the medical history/eligibility 
questionnaire to confirm qualification.  
 
Participants deemed eligible based on inclusion/exclusion criteria will continue to the 
screening skin evaluation.  Ineligible participants will be discontinued. 
 
7.1.1.2 ITA/Skin type determination  
The skin of the participant’s back, between the beltline and shoulder blades, will be 
examined for uneven skin tones and blemishes using a Woods Lamp. All participants 
will acclimate at room temperature (as described in SOP 
) for 10 mins prior to 
the skin being examined. ITA° will then be determined by a study technician; mean L 
*, a*, b* values will be calculated from at least 3 measurements on the back of each 
participant.  An ITA° calculation range greater than a 10-point difference will result in 
disqualification (example: 34.6°-45.4°). 
  
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Qualified participants will be enrolled and scheduled for study procedures. Ineligible 
participants will be disqualified. Each qualifying participant will be assigned a unique 
identifying study number in order of study enrollment. 
 
7.1.2 Initial Unprotected MED (MEDuI) Dose Administration 
Using an indelible marker and template, and with the participant in an upright or prone 
position, a study technician will draw up to 8 rectangles (minimum 6), i.e., up to 8 test 
sites (minimum 6) on the skin of the participant’s back (between the belt-line and 
shoulder blades, lateral to the midline, avoiding any areas with extreme curvature). 
Each rectangle will be 40 square centimeters (cm2) in area, with at least 1 cm between 
the borders of adjacent test sites. Each test site will be further sub-divided into 5 
subsites (exposure sites). The area of each subsite will be ≥ 0.5 cm2; the distance 
between the borders of each subsite will be at least 0.8 cm; the distance between any 
subsite and the edge of its’ test site will be ≥ 1 cm.  
 
With the participant in an upright or prone position, a series of 5 timed UV doses, 
increasing in 25 percent increments (J/m2), will be administered to the designated 
‘MEDuI’ test site.  
  
Table 6. UV Dose Series for MEDuI 
 
 
 
 
After irradiation is complete, an immediate response code will be recorded for each 
subsite in source documentation. 
 
Table 7. Immediate Response Codes 
 
 
 
 
 
The technician will document the identities of the solar simulator, radiometer and 
detector; UV doses; the lamp effective irradiance reading before UV doses (optional: 
after UV doses lamp effective irradiance reading per request of the Study Sponsor); 
Immediate Response Codes; and the UV dose series completion time stamp in source 
documentation.  
 
Participants will be instructed to avoid UV exposure; they will be reminded of the study 
requirements/lifestyle considerations and asked to return to the study site 16 to 24 hrs 
after completion of ‘Day 1’ UV doses. 
Expected MEDu 
0.64 
0.80 
1.00 
1.25 
1.56 
N  No immediate response 
D  Immediate darkening or reddening 
H  Immediate generalized heat response spreading beyond the subsite 
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7.2 
Day 2 
7.2.1 MEDuI Determination 
Participants will return to the study site 16 to 24 hrs later for erythemal response 
evaluation. Each will be questioned non-directively to assess compliance with the 
requirements of the protocol and to identify changes in health/concomitant 
medications. Any changes/AEs will be recorded in source documentation.  All 
participants will acclimate at room temperature for 10 minutes prior to response 
evaluation (as described in SOP 
   
 
A trained evaluator will grade the responses of the UV exposed sites, under warm white 
fluorescent or tungsten illumination of at least 450 lux, using the grading scale shown 
in Table 8. Grades will be recorded, along with any comments, in source documentation 
and the evaluator will time stamp the evaluation completion. 
 
Table 8. Grading Scale for Erythema Responses 
0 No erythema response 
1 Minimally perceptible erythema with no clearly defined borders 
2 Perceptible erythema with clearly defined borders (covering more than 50%  
of the exposure site) 
3 Moderate erythema with sharp borders* 
4 Dark red erythema with sharp borders* 
5 Dark red erythema with sharp borders and possible edema* 
6 Intense erythema with sharp borders and edema* 
 
* If moderate, dark red or intense erythema does not reach borders of exposed site, an explanation will 
be provided in the source documentation. 
 
The MEDuI is defined as the first exposure site in the series with erythema grade ≥ 2.   
 
Participants whose MEDuI can be determined will continue with study procedures.  
Participants whose MEDuI cannot be determined will be discontinued. 
 
The progression of erythema grades must be consistent with the UV doses 
administered. 
 
Participants with pronounced tanning responses are not considered good candidates for 
SPF studies with an erythema endpoint.  They should be discontinued from the study 
and another participant should be added.   
 
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To facilitate study scheduling, participants may leave the study site after MEDuI 
determination and return up to 1 week later to resume study procedures. Re-scheduled 
participants whose testing has been paused will be questioned non-directively on their 
return to assess compliance with the requirements of the protocol and to identify 
changes in health/concomitant medications. to confirm ongoing qualification. Any 
changes/AEs will be recorded in source documentation.  
 
7.2.2 Application of Study Treatments 
7.2.2.1 SPF Standard Application 
The study technician will apply 80 ± 2 mg (2.0mg/cm2 ± 0.05 mg/cm2) of the SPF 
standard to its assigned test site using a fingercot. A double-weighing procedure 
(weighing the syringe/pipette + product + fingercot, prior to and after application) to 
ensure the required quantity of SPF standard is delivered. Using the fingercot and light 
pressure, the SPF standard will be evenly spread over the test site; spreading time will 
be 35 ± 15 secs, depending on the ease of application. 
 
7.2.2.2 Test Product Application 
The study technician will apply 80 ± 2 mg (2.0mg/cm2 ± 0.05 mg/cm2) of the test 
product to its’ assigned test site using a fingercot. A double-weighing procedure 
(weighing boat + product + fingercot, prior to and after application) to ensure the 
required quantity of product is delivered. Using the fingercot and light pressure, the 
test product will be evenly spread over the test site; spreading time will be 35 ± 15 
secs, depending on the ease of application. 
 
7.2.2.3 Additional Application Instructions for All Test Materials 
• The study technician will ensure test materials are homogenous (thoroughly 
mixed and/or shaken well) prior to application 
• Test sites may be cleaned using a dry cotton pad or equivalent prior to test 
material application. 
• Evenness of application will be verified by observation with a Woods Lamp.  If 
non-uniformity or streaking of the test material is noted, the test site shall be 
rejected and may not be used for testing. If another test site is available, re-
application of the test material should be attempted. 
• Test material dispensing (test site allocation, weight (mg), spreading time, drying 
time) will be recorded in source documentation.  
• Wait at least 15 mins after applying the test materials before commencing UV 
irradiation of unprotected and protected sites.  
 
7.2.4 UV Doses for Unprotected and Protected Sites  
7.2.4.1 Repeat Unprotected Minimal Erythema Dose (MEDuR) Determination 
A series of 5 (timed) UV doses, increasing by 25 percent increments (J/m2) across the 
5 subsites, will be administered to the assigned unprotected test site of the back  The 
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UV exposure selected for each subsite will be based on the previous MEDuI evaluation, 
which appears as the series’ mid-point, as shown above in Section 7.1.2, Table 6. 
 
Immediate Response Codes and procedural information will be recorded in source 
documentation as described in Section 7.1.2, Table 7. 
 
7.2.4.2 Protected Minimal Erythema Dose (tpMEDp/ssMEDp) Determination 
A series of 5 (timed) UV doses, increasing by 25 percent increments (J/m2) across the 
5 subsites, will be administered to each protected test site (i.e., the sites treated with 
SPF standard [ssMEDp] and test products [tpMEDp). The UV exposure selected for each 
subsite will be determined by the previously determined MEDuI and the expected SPF 
of the test materials, as shown in Table 9. 
 
Table 9. FDA Final Rule Dose Series 
Expected SPF 
Multiple of expected SPF and Participant 
MEDuI 
< 8 
0.64 
0.80 
1.00 
1.25 
1.56 
> 8 to 15 
0.69 
0.83 
1.00 
1.20 
1.44 
> 15 
0.76 
0.87 
1.00 
1.15 
1.32 
 
Immediate Response Codes and procedural information will be recorded in source 
documentation as described in Section 7.1.2. 
 
While administering treatment evaluation UV doses for any Model 16S (single port) 
testing, as required, the technician may adopt the following procedure to accommodate 
participant scheduling needs.  
• Reduce the test material UV exposure times by the correct UV dose series 
multiplier and immediately continue UV exposures. 
Management approval to adopt this approach and the outcome will be recorded in 
source documentation. 
Participants will be instructed to avoid UV exposure; they will be reminded of the study 
requirements/lifestyle considerations and asked to return to the study site 16 to 24 hrs 
after completion of ‘Day 2’ UV doses. 
 
7.3 Day 3 
7.3.1 MEDuR, ssMEDp and tpMEDp Determination 
Participants will return to the study site 16 to 24 hrs later for erythemal response 
evaluation. Each will be questioned non-directively to assess compliance with the 
requirements of the protocol and to identify changes in health/concomitant 
medications. Any changes/AEs will be recorded in source documentation. All 
participants will acclimate at room temperature for 10 minutes prior to response 
evaluation (as described in SOP 
).   
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A trained blinded evaluator will grade the responses of the UV exposed sites, under 
warm white fluorescent or tungsten illumination of at least 450 lux, using the grading 
scale shown in Table 8. Grades will be recorded, along with any comments, in source 
documentation and the blinded evaluator will time stamp the evaluation completion. 
 
Note: the same blinded evaluator should evaluate erythemal response throughout the 
study. 
 
MED (MEDuR, ssMEDp and tpMEDp) is defined as the first exposure site in the series 
with erythema grade ≥ 2. Erythema grades, comments and the evaluation completion 
time stamp will be recorded in source documentation.  
 
Photographs of the test sites, which do not reveal participant identity, may be taken to 
document unexpected results and/or AEs. 
 
 
8.0 Statistical Analysis  
Statistical analyses will be performed by 
 using Microsoft Excel 365 (2021). Since 
all methodologies for the summary and statistical analyses of the data collected in this 
study are specified in the protocol, a separate Reporting Analysis Plan (RAP) will not be 
created. Any major modification of the analysis plan will be documented as a protocol 
amendment. 
 
8.1 Analysis Population 
The analysis population will include all eligible participants (qualified based on the 
inclusion/exclusion criteria) who are randomized, received study treatment and provide 
valid results. 
 
8.2 Participant Disposition and Demography  
Participant disposition and demographic characteristics will be tabulated and presented 
with summary descriptive statistics (sample size, mean, standard deviation, median, 
minimum and maximum) for continuous variables (e.g., age) and frequency 
distributions for categorical variables (e.g., sex). 
 
8.3 SPF Computation 
The SPF values of each test product (tpSPFi) and the SPF standard (ssSPFi) will first be 
computed for each individual participant (to one decimal place) as follows: 
SPFi = MEDp/MEDuR 
 
The arithmetic mean SPF and standard deviation (SD) will then be calculated 
separately for each test product and the SPF standard from valid SPFi data; the 
standard error (SE) of the mean will also be calculated (n= no. participants who 
provide valid test results). 
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SPF = (∑SPFi)/n 
 
SD = √[(∑SPFi2) – ((∑SPFi)2/n) / (n-1))] 
 
SE = SD/√n 
 
The t value from the ‘2-sided’ Student-t distribution table corresponding to the upper 
5% point with n-1 degrees of freedom will be obtained. 
 
The labeled SPF value will be determined as the largest whole number less 
than the following calculation: 
 
Labeled SPF = Mean SPF – (t * SE) 
 
For the SPF determination of the test products to be considered valid, in compliance 
with the FDA Final Rule 2011, the SPF value of the SPF standard should fall within the 
SD range of the expected SPF (i.e. 16.3 ± 3.43 or 12.87 to 19.73). [1] 
 
8.4 Summary Analyses 
Calculations and statistical analyses will be performed in compliance with the FDA Final 
Rule (2011) [1] and reviewed by 
 Quality Assurance. Individual participant results 
will be tabulated along with summary statistics, including mean SPF, valid test data 
used in the SPF calculations, SD, SE and t-value (as described in Section 8.3). Passed 
or failed grades will also be listed, along with excluded participants and reasons for 
exclusion. 
 
9.0 Rejected Test Data: 
9.1 Invalid Data 
Test data are deemed invalid and shall be excluded under the following circumstances: 
• Erythema is not present on either the unprotected or protected test site(s). 
• Erythema is present at all subsites on either the unprotected or protected test 
site(s). 
• The responses are inconsistent with the series of UV doses administered. 
Data from a maximum of three participants per test material may be invalidated for the 
above reasons.[1] 
 
9.2 Other Reasons for Data Rejection 
Test data may be excluded for other reasons, examples include:  
• Participant was non-compliant with study protocol  
• Participant lost to follow up 
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• Participant unable to complete the study 
• Participant discontinued due to an AE 
• Participant disqualified due to an administrative/technical failure  
• Participant dismissed due to product wash off 
• Participant discontinued/withdrawn (See Section 5.4) 
 
 
10.0 Adverse Events 
The safety population is defined as all randomized participants who received at least 
one dose of a study treatment. 
  
The PI, or designated designee(s), is responsible for detecting, documenting and 
reporting events that meet the definition of an AE or SAE.  
 
The PI, or designated designee(s), is responsible for following up serious AEs (SAEs); 
AEs considered to be test product (or study procedure) related; and AEs that caused 
the participant to discontinue or be withdrawn from the study. 
 
10.1 Definition of an Adverse Event (AE) 
An AE is any untoward medical occurrence in a clinical study participant, temporally 
associated with the use of a test product, whether or not considered related to the test 
product. An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of a test product.  
 
Events Meeting the AE Definition:  
• Unexpected or unusual reactions which occur within a test site that cannot be 
completely described by the scale in Table 8 (e.g., hives) will be recorded as AEs.  
• Any abnormal laboratory test results (hematology, clinical chemistry, or 
urinalysis) or other safety assessments (e.g., ECG, radiological scans, vital sign 
measurements), including those that worsen after test product administration, 
considered clinically significant in the medical and scientific judgment of the PI or 
medically qualified designee (i.e., not related to progression of underlying 
disease).  
• Exacerbation of a chronic or intermittent pre-existing condition including either 
an increase in frequency and/or intensity of the condition after test product 
administration.  
• New conditions detected or diagnosed after test product administration, even 
though it may have been present before the start of the study.  
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.  
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• Signs, symptoms, or the clinical sequelae of a suspected overdose of either test 
product or a concomitant medication. Overdose per se will not be reported as an 
AE/SAE unless it is an intentional overdose taken with possible suicidal/self-
harming intent. Such overdoses should be reported regardless of sequelae.  
• ‘Lack of efficacy’ per se will not be reported as an AE. Such instances will be 
captured in the efficacy assessments. However, the signs, symptoms, and/or 
clinical sequelae resulting from lack of efficacy will be reported as AE if they fulfill 
the definition of an AE. 
 
 
 
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Events NOT meeting the AE definition:  
• Any clinically significant abnormal laboratory findings (if applicable) or other 
abnormal safety assessments which are associated with an underlying disease, 
unless judged by the PI, or medically qualified designee, to be more severe than 
expected for the participant's condition. 
• A medical or surgical procedure (e.g., endoscopy, appendectomy) is not an AE. 
The condition that leads to the procedure is the AE (e.g., gastritis, appendicitis).  
• Situations where an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).  
• Anticipated day-to-day fluctuations in a pre-existing disease/condition present or 
detected at the start of the study that did not worsen.  
• Localized erythema caused by exposure of the skin to UV radiation is expected 
and will not be reported as an adverse event. 
 
10.2. Definition of a Serious Adverse Event (SAE)  
An SAE is a particular category of AE where the adverse outcome is serious. If an event 
is not an AE per definition above, then it cannot be an SAE even if serious conditions 
are met.  
 
A serious adverse event is any untoward medical occurrence at any dose that:  
• Results in death  
• Is life-threatening  
- 
The term 'life-threatening' in the definition of 'serious' refers to an event in 
which the participant was at risk of death at the time of the event. It does 
not refer to an event, which hypothetically might have caused death, if it 
were more severe.  
• Requires inpatient hospitalization or prolongation of existing 
hospitalization  
- 
In general, hospitalization signifies that the participant has been detained 
(usually involving at least an overnight stay) at the hospital or emergency 
ward for observation and/or treatment that would not have been 
appropriate in the physician's office or outpatient setting. Complications 
that occur during hospitalization are AEs. If a complication prolongs 
hospitalization or fulfills any other serious criteria, the event is serious. 
When in doubt as to whether ‘hospitalization’ occurred, or was necessary, 
the AE should be considered serious.  
- 
Hospitalization for elective treatment of a pre-existing condition that did 
not worsen from baseline is not considered an AE.  
• Results in persistent or significant disability /incapacity  
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- 
The term disability means a substantial disruption of a person's ability to 
conduct normal life functions.  
- 
This definition is not intended to include experiences of relatively minor 
medical significance such as an uncomplicated headache, nausea, vomiting, 
diarrhea, influenza, and accidental trauma (e.g., sprained ankle) which may 
interfere with or prevent everyday life functions but do not constitute a 
substantial disruption.  
• Results in congenital anomaly/birth defect 
• Other situations:  
- 
Medical or scientific judgment should be exercised in deciding whether SAE 
reporting is appropriate in other situations, such as important medical 
events that may not be immediately life-threatening or result in death or 
hospitalization, but may jeopardize the participant or may require medical 
or surgical intervention to prevent one of the other outcomes listed in the 
above definition. These events should usually be considered serious.  
- 
Examples of such events include invasive or malignant cancers, intensive 
treatment in an emergency room or at home for allergic bronchospasm, 
blood dyscrasias or convulsions that do not result in hospitalization, or 
development of drug dependency or drug abuse. 
Note: Classification of an AE as 'serious' is based on the outcome of the event and is a 
factor in determining reporting requirements. 
 
10.3 Expected Events 
UV Expected Events: 
Possible/expected side effects on and/or around the test sites associated with UV 
exposure include the following:  
• Erythema (sunburn) 
• Mild discomfort 
• Itching 
• Edema (swelling) 
• Dryness/Tightness 
• Peeling 
• Papules 
• Stinging/Burning 
• Ulceration or irritation 
• Heat 
• Hyperpigmentation/hypopigmentation are possible 
 
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Any expected side effects experienced by the participant after UV exposure of the test 
sites are not to be considered AEs.  Test products may not perform up to the expected 
protection level.  Under protection outcomes are potential anticipated events and are 
also not to be considered AEs.  However, if any of these parameters/outcomes appear 
to be highly exacerbated, more than normally associated with the test procedures as 
determined by the PI, or designee, and lead to discontinuation, the event will be 
documented as an AE.   
 
Skincare Product Expected Events: 
There is always the possibility of irritation or a skin reaction to any product applied to 
the skin.  Examples of possible skincare product reactions are: 
• Redness 
• Dryness/tightness 
• Peeling 
• Itching 
• Burning/stinging 
• Allergic reaction 
 
Any skin reaction associated with the application of a test product to the test site will 
be considered an AE and documented as such.  
  
10.4. Time Period and Frequency for Collecting AE and SAE Information  
All AEs, and therefore all SAEs, will be collected immediately after a participant 
provides consent to participate in the trial by the completion (signing) of the ICF and 
until 14 days following last administration of test product (or last study procedure).  
Medical occurrences that began before obtaining informed consent will be recorded in 
the source documentation as Medical History/Current Medical Conditions, not as AEs.  
 
All SAEs will be recorded and reported to the Sponsor, or designee, immediately and 
under no circumstance should this exceed 24 hours. The PI, or designee, will submit 
any updated SAE data to the Sponsor within 24 hours of it being available.  
 
The PI is not obligated to actively seek AEs or SAEs after the conclusion of study 
participation. However, if the PI learns of any SAE, including a death, at any time after 
a participant has been discharged from the study, and they consider the event to be 
reasonably related to the test product or study participation, the PI must promptly 
notify the Sponsor. 
 
10.5. Reporting Procedures  
The PI, or medically qualified designee, is responsible for detecting, documenting and 
reporting all events that meet the definition of an AE and remains responsible for 
following up on AEs that are serious or considered to be related to a test product, 
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participation in the study or a study procedure, or that caused the participant to 
discontinue a test product or the study.  
 
Each participant will be questioned about AEs. Spontaneously reported AEs and those 
elicited by asking non-directive questions (such as "How do you feel?") will be 
assessed, recorded in AE-specific source documentation and reported appropriately. 
The PI, or medically qualified designee, is to report all directly observed AEs and all AEs 
spontaneously reported by a participant. 
 
Each AE should be assessed to determine if it meets the criteria for a SAE. If an SAE 
occurs, expedited reporting will follow local and international regulations, as 
appropriate.  
 
When an AE occurs, it is the responsibility of the PI, or medically qualified designee, to 
review all documentation (e.g., hospital progress notes, laboratory and diagnostics 
reports) related to the event. The PI, or designee, will record all relevant information 
regarding an AE in AE-specific source documentation and all details relating to an SAE 
on the paper SAE form provided.  
 
It is not acceptable for the PI, or medically qualified designee, to send photocopies of a 
participant’s medical records to GSK CH in lieu of completion of AE-specific source 
documentation or the SAE form. There may be instances when copies of medical 
records are requested by GSK CH. In this instance, all participant identifiers, except for 
the participant number, will be redacted prior to sharing with GSK CH.  
 
The PI, or medically qualified designee, will attempt to establish a diagnosis of the 
event based on signs, symptoms, and/or other clinical information. The diagnosis 
should be the documented as the AE/SAE, where known, and not the individual 
signs/symptoms (e.g., upper respiratory tract infection, seasonal allergy; not cough, 
runny nose).  
 
AEs elicited by the PI, or medically qualified designee, during study visits should be 
recorded in AE-specific source documentation and/or using the SAE form, as 
appropriate. Care will be taken not to introduce bias when questioning a participant 
about changes in their health. Open-ended and non-directive verbal questioning should 
be used. 
 
Reporting an Adverse Event:  
AEs will be reported using AE-specific source documentation by the PI or site staff and 
the Sponsor-supplied SAE form, when appropriate, using concise medical terminology. 
Where the same data are collected, AE-specific source documentation and the SAE 
form must be completed in a consistent manner; the same AE terms should be used on 
both.  
 
Reporting a Serious Adverse Event:  
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In addition to recording the details in AE-specific source documentation, an SAE form 
should be completed, as fully as possible. Hard copies of the paper SAE form will be 
provided for the Investigator Site Master File. Original SAE forms should be retained in 
the Investigator Trial Master File.  
 
It is essential to enter the following information:  
• Protocol and participant identifiers  
• Participant demography  
• Description of event(s), with diagnosis if available 
• PI opinion of relationship to test product (or study procedure, if appropriate)  
• Criterion for seriousness 
 
The following are desirable and are of particular relevance for PI and GSK CH 
assessment of the SAE report:  
• Date of onset of event  
• Date event stopped, if relevant  
• Test product start date  
• Test product end date, if relevant  
• Action taken in relation to the test product  
• Outcome if known 
 
The SAE form, completed as fully as possible, must be scanned and e-mailed to the 
GSK CH Clinical Operations Safety Reporting email box with the GSK CH study number 
and participant number in the title field of the email immediately and under no 
circumstance should this exceed 24 hours after study site personnel learn of the 
event. The PI will submit any updated SAE data to the sponsor immediately and 
under no circumstance should this exceed 24 hours of it being available. The GSK 
CH Study Manager should also be notified of the situation by telephone or email.  
 
Email Serious Adverse Events to: 
 
 
The GSK CH Study Manager, or designee, will be responsible for forwarding the SAE 
form to the Case Management Group, Global Clinical Safety and Pharmacovigilance 
mailbox (
). The initial report will be followed up with more 
information as relevant, or as requested by the Sponsor. 
 
10.6. Evaluating Adverse Events  
Assessment of Intensity:  
The PI, or medically qualified designee, will assess intensity for each AE reported 
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during the study and will assign one of the following categories. 
• Mild: An event that is easily tolerated by the participant, causing minimal 
discomfort and not interfering with everyday activities.  
• Moderate: An event that is sufficiently discomforting to interfere with normal 
everyday activities  
• Severe: An event that prevents normal everyday activities. 
 
NOTE: An AE classified as ‘severe’ should not be confused with an SAE.  
‘Severe’ is a category utilized to classify the intensity of an event; both non-serious AEs 
and SAEs can be classified as ‘severe’. For example, a headache may be ‘severe’ 
(interferes significantly with the participant's usual function) but would not be classified 
as ‘serious’ unless it met one of the criteria for an SAE, as described above (Section 
1.2.2.). An event is defined as 'serious' when it meets at least 1 of the pre-defined 
outcomes as described in Section 1.2.2., not when it is classified as ‘severe’. 
 
Assessment of Causality  
Causality is one of the criteria used to determine regulatory reporting requirements. 
For each AE (serious and non-serious), the PI, or medically qualified designee, must 
provide an assessment of causality in the AE-specific source documentation and, for 
SAEs, on the SAE form.  
 
The PI, or medically qualified designee, will use clinical judgment to determine 
causality, having also consulted the Safety Statement provided by the Sponsor for this 
study. Alternative causes, such as underlying disease(s), concomitant therapy, other 
risk factors and the temporal relationship of the event to the test product will also be 
taken into consideration and investigated.  
 
There may be situations where an SAE has occurred, and the PI has minimal 
information to include in the initial report to GSK CH. The PI is required to make an 
assessment of causality prior to the initial transmission of the SAE form to GSK CH; 
they may change their opinion of causality in light of follow-up information and send an 
SAE follow-up report with the updated causality assessment.  
 
Relationship to Test Material  
The relationship or association of the AE to test product will be characterized as 
‘unlikely’, ‘possible’ or ‘probable’ (Table 10).  
 
A ‘reasonable possibility’ of relationship conveys there are facts, evidence and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled 
out. The facts, evidence and/or arguments which suggest a causal relationship should 
be provided in the AE report.  
 
For safety analyses, AEs classified as a ‘possible’ or ‘probable’ association to test 
product shall be considered test product-related AEs.  
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Follow-up of an AE, after discontinuation of exposure to test product is required if the 
AE or its sequelae persist. Follow-up is required until the event or its sequelae resolve 
or stabilize at a level acceptable to the PI and to the Medical Monitor. 
 
 
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Table 10: Causality Assessment 
Causality 
Term 
Assessment Criteria 
Probable 
Event or laboratory test abnormality, with plausible time 
relationship to test product exposure 
Unlikely to be attributed to condition (or disease) or other 
products in use by participant 
Response to withdrawal clinically reasonable 
Re-challenqe satisfactory or not required 
Possible 
Event or laboratory test abnormality, with reasonable time 
relationship to test product use 
Could also be explained by condition (or disease) or other 
products in use by participant 
Response to withdrawal unclear or lacking 
Unlikely 
Event or laboratory test abnormality, with a time to test product 
use that makes a relationship improbable (but not impossible) 
Condition (or disease) or other products provide plausible 
explanations 
 
 
10.7. Follow-up of AEs and SAEs  
After the initial AE/SAE report, the PI, or medically qualified designee, is required to 
proactively follow up with each participant and provide further information on the 
participant's condition. All AEs (serious and non-serious) will be followed until 
resolution, until the condition stabilizes, until the event is otherwise explained or until 
the participant is lost to follow-up.  
 
The PI, or medically qualified designee, is obligated to perform or arrange for the 
conduct of supplemental measurements and/or evaluations as may be indicated or as 
requested by GSK CH to elucidate as fully as possible the nature and/or causality of an 
AE. This may include additional laboratory tests or investigations, histopathological 
examinations or consultation with other health care professionals. New or updated 
information will be recorded on the AE CRF page and, for SAEs, on the SAE form. The 
PI, or designee, will submit updated SAE data to GSK CH within 24 hours of receipt of 
the information.  
 
The PI is not obliged to actively seek AEs in former study participants. However, if the 
PI learns of a SAE, including death, at any time after a participant has been discharged 
from the trial, and considers the event reasonably related to the test product or study 
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participation, they will promptly notify GSK CH by emailing the information to the GSK 
CH Clinical Operations Safety Reporting email box 
).  
The GSK CH Study Manager, or designee, will be responsible for forwarding the 
information to the Case Management Group, Global Clinical Safety and 
Pharmacovigilance group mailbox at GSK 
).  
 
The PI, or medically qualified designee, will submit any updated SAE data to GSK CH 
within the designated reporting time frames.  
 
10.8. Withdrawal Due to an Adverse Event  
Withdrawal due to an AE should be distinguished from withdrawal due to other causes, 
according to the definition of an AE noted earlier, and recorded in the appropriate AE-
specific source document. When a participant withdraws because of an SAE, the SAE 
must be reported as already described.  
 
10.9. Regulatory Reporting Requirements for SAEs  
GSK CH has a legal responsibility to notify, as appropriate, the local regulatory 
authority and other regulatory authorities about the safety of a product under clinical 
investigation. Prompt notification of SAEs by the PI to GSK CH is essential so that legal 
obligations and ethical responsibilities towards the safety of study participants are met.  
 
GSK CH will comply with country specific regulatory requirements relating to safety 
reporting to the regulatory authority and IRB, and other investigators if applicable.  
 
Investigator safety reports must be prepared for suspected unexpected serious adverse 
reactions (SUSAR) according to local regulatory requirements and sponsor policy and 
forwarded to investigators, as required.  
 
An investigator who receives an investigator safety report describing a SAE or other 
specific safety information (e.g., summary or listing of SAE from the sponsor) will 
review it, file it with the Safety Statement in the Investigator Trial Master File and then 
notify the IRB, if appropriate, according to local requirements. 
 
10.10. Pregnancy  
Time Period for Collecting Pregnancy Information  
Pregnancy information will be collected on all pregnancies reported while a female 
participant is taking part in the study, from the signing of informed consent until 14 
days after last administration of test product.  
 
Action to be Taken if Pregnancy Occurs  
The PI, or designee, will record pregnancy information on the pregnancy form supplied 
by the Sponsor. The completed form should be scanned and e-mailed to the GSK CH 
Clinical Operations Safety Reporting email box 
 
within 24 hours of learning of the pregnancy. The GSK CH Study Manager, or designee, 
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will be responsible for forwarding the pregnancy form to the Case Management Group, 
Global Clinical Safety and Pharmacovigilance mailbox 
. Original 
pregnancy information forms should be retained in the Investigator Trial Master File. 
 
The female participant will be followed to determine the outcome of the pregnancy. 
Information on the status of the mother and infant/neonate (including concomitant 
medications taken by the mother during the pregnancy) will be forwarded by the PI, or 
designee, to the GSK CH Clinical Operations Safety Reporting email box and the GSK 
CH Study Manager, or designee, will forward this information to the Case Management 
Group, Global Clinical Safety and Pharmacovigilance group mailbox at GSK 
. Generally, follow-up will be no longer than 6 to 8 weeks after 
the estimated delivery date. Any termination of the pregnancy will be reported.  
 
While pregnancy itself is not considered to be an AE, abnormal pregnancy outcomes 
(e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic 
pregnancy) are, and should be recorded as an SAE. Any female participant who 
becomes pregnant during the study will be withdrawn. If a female participant later 
discovers they were pregnant during the study, i.e., after their participation completed, 
their data will be considered valid for statistical analysis purposes. 
 
11.0 Data Recording and Study Record Maintenance  
Safety/efficacy data and additional clinical observations will be recorded in source 
documentation (e.g., case report forms [CRFs]) in accordance with the ALCOA+ 
principles of data integrity; data should be attributable, legible, contemporaneous, 
original, accurate, complete, consistent, enduring and available. Correction of data 
recorded in source documentation will be carried out accordance with 
 SOPs. 
  
Source documents will include completed ICFs, original records of clinical/instrumental 
observations, test product disposition/product accountability, AE reports, results and 
activities necessary to reconstruct and evaluate the study. Source documents will be 
peer-reviewed by the site staff as per 
 standard practice and/or in accordance with 
 SOPs.  
 
Source documents and other study records (e.g., protocol, protocol amendments/ 
deviations, IRB approval(s), correspondence with the Sponsor/IRB, monitor 
log/reports) will be maintained in the Investigator Trial Master File in accordance with 
the intent and purpose of GCP guidelines, 
SOPs and all applicable laws and 
regulations.  
 
12.0 Ethical Review 
The Sponsor, Monitor(s) and PI will assure all aspects of the study are conducted in 
accordance with applicable regulations and laws guiding the protection of human 
subjects, including regulations requiring informed consent (Informed Consent of Human 
Subjects, 21 CFR Part 50, Subpart B) and the approval and ongoing review of the 
research by an IRB (Institutional Review Boards, 21 CFR Part 56). The study will be 
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conducted in accordance with the principles of the Declaration of Helsinki (as 
amended), the Belmont Report and Good Clinical Practice (GCP). 
 
The PI will submit the protocol for the proposed clinical investigation,  the ICF , an 
ingredients listing for each test product and the SPF standard, the Sponsor-supplied 
Safety Statement, advertising materials and any other relevant documents, as 
appropriate, to the following duly constituted Institutional Review Board (IRB) for 
review. Written IRB approval of each item is required prior to study initiation. 
 
Advarra IRB 
 
The PI will assure that all aspects of the institutional review are conducted in 
accordance with current federal regulations. The letter documenting IRB approval (with 
the names and titles of the IRB members) will be provided to the Sponsor. 
Amendments to the protocol or the ICF will be subject to the same IRB review 
requirements as the original documents.  
 
Should study duration be extended, the PI will submit a progress report, at least 
annually, to the IRB. This report will include: the total number of test products 
evaluated; a description of any changes in study procedures or amendments to the 
protocol; deviations from the protocol; the number and type of participants evaluated; 
the number of participants who discontinued (and the reasons for discontinuation); the 
number of participants who completed the trial; a description of any AEs/SAEs. 
 
13.0 Protocol/ICF Amendment  
Any change to the approved protocol and/or ICF must be made by formal amendment 
of the original document. The amended document must be approved in writing by the 
PI and the Sponsor prior to implementation. Depending on the nature of the change, 
IRB approval may also be required prior to implementation; administrative changes will 
be notified to the IRB. 
 
14.0 Protocol Deviation  
The PI and site staff will not deviate intentionally from this protocol for any reason 
without prior approval of the Sponsor and the IRB, except when the change is 
necessary to eliminate an apparent immediate hazard to study participants. In that 
event, the PI must notify the Sponsor and the IRB in writing within 5 working days of 
the change being implemented.  
  
15.0 Clinical Study Report (CSR) 
On completion of the study, the PI will provide the Sponsor with three CSRs (one per 
test product). Each CSR will include (but not be limited to): study start and end dates; 
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test product identification and expected SPF; SPF standard identification and expected 
SPF; characterization of the UV source; tabulation of participant demographics; 
erythema grades; MEDs; descriptive and inferential statistics including SPFi values with 
valid and rejected data for test products and SPF control, and mean SPF values with 
SD; summary of safety data (AEs/SAEs), or confirmation there were no AEs; protocol 
amendments; protocol deviations; conclusions; identification of the technician who 
conducted the irradiation procedures, by participant, and lamp calibration data; any 
other reporting requirements for static SPF studies specified in the FDA Final Rule [1]. 
 
16.0 Quality Control and Quality Assurance  
This study will be conducted under pertinent Good Clinical Practice Guidelines, other 
applicable regulatory requirements, and testing facility Standard Operating Procedures.  
 
16.1 Study Monitoring by the Sponsor 
In accordance with current FDA regulations and GCP guidelines, study monitors and 
other Sponsor representatives may periodically inspect study-related data at the study 
site at pre-agreed, mutually convenient times, during or after completion of the study 
(Guidance for Industry: Oversight of clinical investigations - A risk-based approach to 
monitoring, DHHS, FDA, August 2013.). Monitoring provides the Sponsor with the 
opportunity to evaluate the progress of the study, verify the accuracy and 
completeness of source documentation, assure all protocol requirements, applicable 
FDA laws and regulations and the PI's obligations are being fulfilled, and to resolve any 
issues. 
 
16.2 Study Review by 
 Quality Assurance 
Study related documents, including source documents, raw data, statistical outputs and 
CSRs will be examined for completeness, accuracy and proper documentation practices 
by 
Quality Assurance personnel. 
 
17.0 Medical Oversight  
The Sponsor will ensure access to an appropriately experienced GSK CH physician/ 
clinical research scientist to be contacted by study staff for advice on medical questions 
or problems in the event that the established communication pathways between the 
study site and Sponsor’s representatives are not available. The contact details of this 
individual (Medical Monitor) will be documented in the Study Contact List located in the 
Investigator Trial Master File held at the study site. 
  
Contact details for the Medical Monitor are not intended for direct use by study 
participants. To facilitate access to appropriately qualified medical personnel for study-
related medical questions and/or problems, participants will be provided with a contact 
card. The contact card will provide, as a minimum, protocol identifiers, the participant’s 
study identification number, contact information for the study site/PI. The site should 
contact the Medical Monitor in the event that the PI cannot be reached to provide 
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advice on a medical question or problem identified by a healthcare professional other 
than the PI. 
 
18.0 Clinical Study Products  
Prior to use in the clinical study, the test products will be securely stored at room 
temperature and humidity and protected from direct sunlight. Unused test products will 
be returned to the Sponsor. 
 
The Sponsor assumes responsibility for the purity, stability, characterization and 
adequate preservation of the test products. The Sponsor assumes responsibility for 
determining the test products are safe for use in humans as described in this protocol. 
 
19.0 Record Retention 
All original documentation and records pertaining to the conduct of this study will be 
retained by 
. for 15 years from the time the final CSRs are issued.  
 
At any time prior to the completion of the 15th archival year, the Sponsor may submit a 
written request to obtain custody of these documents and records once the 
 
archive period has been completed. This transfer shall be performed at the expense of 
the Sponsor. In the absence of such written requests, related records and documents 
shall be destroyed at the end of the CPT archive period, with no further notice, in a 
manner that renders them useless.  
 
20.0 Participant Confidentiality  
. will ensure the names/identities of all study participants are kept 
confidential; participants’ names/identities will not appear in any source documents or 
study-related records provided to the Monitor/Sponsor. Should study records be 
required for inspection, participants’ names/identities should be redacted and replaced 
by their study ID number.  
 
21.0 Indemnification 
The Sponsor agrees to indemnify, defend, and hold harmless 
 
, from any demands, costs, or judgements arising out of or connected with the 
non-negligent use of the test products or performance of activities to be carried out 
pursuant to this Protocol.  
. shall notify the Sponsor within 10 
working days after receipt of notice of injury, claim or lawsuit.  In cases where a 
service agreement exists, the terms of the service agreement prevail. 
 
22.0 Communication and Publication of Results  
The Sponsor shall retain ownership of all study data, data analysis and reports which 
result from this study. All information generated by the study should be regarded as 
confidential. CSRs are for the exclusive use of the person, partnership, or corporation 
to whom they are addressed, and neither the reports, nor the name of 
 nor 
any member of its staff, may be used in connection with the advertising or sale of any 
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product or process without prior written authorization by a legally binding officer of 
 
 
 
 
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23.0 Protocol Approvals 
 
 
 
 
For 
.: Electronic Signature 
 
_________ 
__ 
PI (Signature) 
 
                  
 
Date 
 
 
_
__________ 
 
PI Name (Print)  
 
 
 
 
For Sponsor: 
 
 
_________ 
__ 
Sponsor’s Representative (Signature) 
 
Date 
 
_________________________ 
 
 
Name & Position in GSK CH (Print)  
 
 
 
 
24.0 References 
1. U. S. Food and Drug Administration.  Labeling and Effectiveness Testing; 
Sunscreen Drug Products for Over-the-Counter Human Use; Final Rule; 21 CFR 
Parts 201 and 310.  Federal Register, Vol. 76, No. 117, June 17, 2011.  pp. 
35660-35665. 
2. Guideline for the colorimetric determination of skin color typing and prediction of 
the minimal erythema dose (MED) without UV exposure. Colipa, 2007. 
 
 
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