Sun Protection Factor (SPF) Determination of Two Sunscreen-Containing Lip Balms

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04749459
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 3
• Actual Duration (Days): 28
• Patients Per Site Per Month: 15.2

Study Details

Study Description

Brief Summary

The aim of this study is to determine the SPF of two test materials ChapStick Moisturizer, Classic Flavor and ChapStick Moisturizer, Strawberry Flavor using the methodology described in the International Standard Test Method. This static methodology also meets the requirements of the Australia/New Zealand standard.

Condition or Disease	Intervention/Treatment	Phase
Sunscreening Agents	Drug: ChapStick Moisturizer, Strawberry Flavor; Drug: ChapStick Moisturizer, Classic Flavor; Drug: ISO 24444:2010 P2 Standard Reference Sunscreen	N/A

Detailed Description

A single-center, randomized, evaluator blind, intra-individual comparison, no treatment and positive controlled clinical study to determine the SPF of two ChapStick sunscreen-containing lip balms as per ISO 24444:2010. For each participant, 4 test sites will have a random assignment number for up to two test materials, control standard, and minimal erythemal dose of unprotected skin (MEDu), with at least 3 of the test sites being utilized for application. All three test sites will be exposed to UV radiation at the expected MED and subsequently evaluated for erythema 16-24 hours after UV exposure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Sunscreen Efficacy With the Sun Protection Factor Assay and Calculation of the Label SPF - ISO 24444 (2010) Test Method & Australia/New Zealand Test Method
• Actual Study Start Date: Mar 3, 2021
• Actual Primary Completion Date: Mar 31, 2021
• Actual Study Completion Date: Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ChapStick Moisturizer, Classic Flavor This arm will include all the test sites on the participants back where ChapStick Classic Moisturizer (ANZ) will be applied.	Drug: ChapStick Moisturizer, Classic Flavor; A single topical application of ChapStick Moisturizer, Classic Flavor will be applied to the appropriate 40 cm^2 test site (on the back of each participants). This application shall provide a test material film of approximately 2.00 +/- 0.05 mg/cm^2, using 80 +/-2 mg of material.
Experimental: ChapStick Moisturizer, Strawberry Flavor This arm will include all the test sites on the participants back where ChapStick Strawberry Moisturizer (ANZ) will be applied.	Drug: ChapStick Moisturizer, Strawberry Flavor; A single topical application of ChapStick Moisturizer, Strawberry Flavor will be applied to the appropriate 40 square centimeter (cm^2) test site (on the back of each participants). This application shall provide a test material film of approximately 2.00 +/- 0.05 milligram per centimeter square (mg/cm^2), using 80 +/-2 milligrams (mg) of material.
Active Comparator: ISO 24444:2010 P2 Standard Sunscreen This arm will include all the test sites on the participants back where ISO 24444:2010 P2 Standard Sunscreen will be applied.	Drug: ISO 24444:2010 P2 Standard Reference Sunscreen; A single topical application of ISO 24444:2010 P2 Standard Sunscreen will be applied to the appropriate 40 cm^2 test site (on the back of each participants). This application shall provide a test material film of approximately 2.00 +/- 0.05 mg/cm^2, using 80 +/-2 mg of material.

Outcome Measures

Primary Outcome Measures

1. Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values [Up to 24 hours post UVR exposure]

   Arithmetic mean of all valid SPFi values of each product on each participant was calculated from the individual Minimal Erythemal Dose (MED) on product treated (MEDp) test sites in relation to unprotected (MEDu) test sites 16-24 hrs after exposure to UVR. SPFi = MEDp/MEDu. No inferential statistical analysis was performed for this outcome. The MED is defined as the lowest dose of UVR that produces the first perceptible unambiguous erythema with defined borders appearing over most of the field of UVR exposure. The UVR exposure should be increased in geometric progression with 25% dose increment in relation to the expected SPF values. All individual SPF values were converted arithmetically to calculate SPF of test material (or control standard).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

• Participant must read and execute an informed consent document (that includes a HIPAA statement) indicating that the participant has been informed of all pertinent aspects of the trial before any assessment is performed;

• Participant must complete a Medical History Form (MHF) prior to their trial initiation;

• Participant must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures;

• Participant must agree not to expose their back to additional sunlight or tanning beds, as either can alter the test results;

• Participant must agree not to apply any topical skin-care product to the test sites during this trial;

• Male or female participants of childbearing potential must agree to use a highly effective method of contraception throughout the trial and for 14 days after the last application of assigned treatment. A participant is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active;

• Female participants of childbearing potential must be willing to comply with urine pregnancy testing requirements prior to initiation of trial testing procedures and as may be required for the duration of the trial;

• Participant must be considered dependable and capable of understanding and following directions;

• Participant must have self-perceived Fitzpatrick skin phototype I, II, or III:

Skin Phototype Sunburn and Tanning History I Always burn easily; never tans II Always burns easily; tans minimally III Burns moderately; tans gradually; and

• Participant must have an Individual Typology Angle value >28 degrees, determined by the Testing Facility by colorimetric methods, within 1 week of trial participation.

Exclusion Criteria

• Participant is in ill health as determined by the Principal Investigator;

• Participant is an employee of the Clinical Division of the investigational site or a member of their immediate family;

• Participant is a GSK CH employee directly involved in the conduct of the trial or a member of their immediate family;

• Female participant is pregnant or intending to become pregnant over the duration of the trial or any female participant of childbearing potential who fails to produce a negative urine pregnancy test;

• Female participant who is lactating (self-reported);

• Participant using medication with photo-sensitizing potential;

• Participant has a history of adverse reactions or hypersensitivity to azo dyes, cosmetics, OTC drugs, or other topical personal care products;

• Participant taking medications other than birth control that could influence the purpose, integrity or outcome of the trial;

• Participant has used topical or systemic steroids, antihistamines, or antibiotics within 7 days of trial initiation or during the trial;

• Participant has used anti-inflammatory medications within 7 days of trial initiation or during the trial, that in the opinion of the PI, could interfere with the trial;

• Participant has used medication suspected of causing photobiological reactions (e.g., tetracyclines, thiazides, etc.), that has not been taken by the participant through a summer season;

• Participant has a dermatological condition;

• Participant has a history of abnormal response to the sun, or a condition such as lupus erythematosus or skin cancer;

• Participant uses tanning beds frequently;

• Participant whose test site was exposed to sunlight within the previous 4 weeks;

• Participant has a sunburn, suntan, uneven skin color, visible skin disease, scarring, or tattoo that would interfere with evaluation of test results; Note: The presence of non-dysplastic nevi, blemishes, or moles will be acceptable if, in the PI's judgment, they will neither compromise the clinical trial, nor jeopardize a participant's safety. A participant with dysplastic nevi should be disqualified.

• Participant has existing sun damage in the test site;

• Participant has excessive hair in the test area and are unwilling to have it clipped; or

• Participant whose test sites have been used for clinical testing in which they were exposed to ultraviolet radiation within the past 2 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Fairfield	New Jersey	United States	07004

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 25, 2021

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT04749459
• Other Study ID Numbers: 215232
• First Posted: Feb 11, 2021
• Last Update Posted: Mar 16, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sunscreening Agents

Study Results

Participant Flow

Recruitment Details

The study was conducted at single center in United States.

Pre-assignment Detail

Total 14 participants were enrolled; up to 4 test sites on the back of each participant were randomized to treatment (2 test products, P2 Control Standard and 1 untreated site used to calculate MEDu). In total,12 participants were treated with CSM Classic (12 test sites);10 participants were treated with CSM Strawberry (10 test sites); 14 participants received P2 Control Standard (14 test sites). One participant was excluded from the final CSM Classic vs P2 Control dataset due to invalid data.

Arm/Group Title	All Study Participants
Arm/Group Description	Study participants were randomly assigned to receive a single topical application of 3 study treatments (ChapStick Moisturizer [CSM] Classic; CSM Strawberry Flavor; P2 Control Standard) or no treatment to 4 test sites on the back; 80 +/- 2 milligram (mg) product was applied to each 40 square centimeters [cm^2] test site (2.00 +/- 0.05 mg/cm^2). If there was space for only 3 test sites on the participant's back, only one of the two ChapStick products was evaluated. Test sites received a progressive sequence of timed ultraviolet radiation (UVR) exposures and were evaluated for erythema immediately after irradiation and 16-24 hours (hrs) later. A total of 14 participants were enrolled; up to 4 test sites on the back of each participant were randomized to treatment (2 test products, P2 Control Standard and 1 untreated site used to calculate MEDu). In total, 12 participants were treated with CSM Classic (12 test sites); 10 participants were treated with CSM Strawberry (10 test sites); 14 participants received P2 Control Standard (14 test sites). One participant was excluded from the final CSM Classic vs P2 Control dataset (invalid data: erythema in all sub-sites treated with the test product).
Period Title: Overall Study
STARTED	14
CSM Classic	12
CSM Strawberry Flavor	10
P2 Control Standard	14
COMPLETED	14
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	Study participants were randomly assigned to receive a single topical application of 3 study treatments (ChapStick Moisturizer [CSM] Classic; CSM Strawberry Flavor; P2 Control Standard) or no treatment to 4 test sites on the back; 80 +/- 2 milligram (mg) product was applied to each 40 square centimeters [cm^2] test site (2.00 +/- 0.05 mg/cm^2). If there was space for only 3 test sites on the participant's back, only one of the two ChapStick products was evaluated. Test sites received a progressive sequence of timed ultraviolet radiation (UVR) exposures and were evaluated for erythema immediately after irradiation and 16-24 hours (hrs) later. A total of 14 participants were enrolled; up to 4 test sites on the back of each participant were randomized to treatment (2 test products, P2 Control Standard and 1 untreated site used to calculate MEDu). In total, 12 participants were treated with CSM Classic (12 test sites); 10 participants were treated with CSM Strawberry (10 test sites); 14 participants received P2 Control Standard (14 test sites). One participant was excluded from the final CSM Classic vs P2 Control dataset (invalid data: erythema in all sub-sites treated with the test product).
Overall Participants	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	11 78.6%
>=65 years	3 21.4%
Sex: Female, Male (Count of Participants)
Female	7 50%
Male	7 50%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values
Description	Arithmetic mean of all valid SPFi values of each product on each participant was calculated from the individual Minimal Erythemal Dose (MED) on product treated (MEDp) test sites in relation to unprotected (MEDu) test sites 16-24 hrs after exposure to UVR. SPFi = MEDp/MEDu. No inferential statistical analysis was performed for this outcome. The MED is defined as the lowest dose of UVR that produces the first perceptible unambiguous erythema with defined borders appearing over most of the field of UVR exposure. The UVR exposure should be increased in geometric progression with 25% dose increment in relation to the expected SPF values. All individual SPF values were converted arithmetically to calculate SPF of test material (or control standard).
Time Frame	Up to 24 hours post UVR exposure

Outcome Measure Data

Analysis Population Description

All randomized participants who received study treatments (test and control standard) and provided valid SPFi values.

Arm/Group Title	CSM Classic	P2 Control Standard (vs. CSM Classic)	CSM Strawberry Flavor	P2 Control Standard (vs. CSM Strawberry Flavor)
Arm/Group Description	All participants with evaluable data for CSM Classic vs P2 Control pairwise comparison.	All participants with evaluable data for CSM Classic vs P2 Control pairwise comparison.	All participants with evaluable data for CSM Strawberry Flavor vs P2 Control pairwise comparison.	All participants with evaluable data for CSM Strawberry Flavor vs P2 Control pairwise comparison.
Measure Participants	11	11	10	10
Mean (Standard Deviation) [Ratio]	17.3 (3.5)	17.9 (4.4)	19.3 (4.5)	18.4 (4.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CSM Classic, P2 Control Standard (vs. CSM Classic)
	Comments
	Type of Statistical Test	Other
	Comments	A minimum of 10 valid results was defined as the number required to produce mean study product (or control standard) SPF with 95% confidence interval (CI) within +/- 17% of the measured mean SPF of the study product (or control standard).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		CSM Classic: CIs +/- 13.7% P2 Control Standard (vs. CSM Classic) CIs +/- 16.4%

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CSM Strawberry Flavor, P2 Control Standard (vs. CSM Strawberry Flavor)
	Comments
	Type of Statistical Test	Other
	Comments	A minimum of 10 valid results was defined as the number required to produce mean study product (or control standard) SPF with 95% confidence interval (CI) within +/- 17% of the measured mean SPF of the study product (or control standard).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		CSM Strawberry Flavor: CIs +/- 16.6% P2 Control Standard (vs CSM Strawberry Flavour): CIs +/- 16.0%

Adverse Events

Time Frame	From screening until 14 days after last dose administration of trial product (Up to 29 days)
Adverse Event Reporting Description	Adverse events (AEs) and Serious Adverse Events (SAEs) were to be collected from time of consent until 14 days after receiving study treatment; SAEs were to be reported within 24 hrs of detection. Diagnosis was to be documented (were known), not individual signs/symptoms. AEs were to be classified by Intensity (mild, moderate, severe); Causality (probable, possible, unlikely); Serious or Non-Serious.
Arm/Group Title	CSM Classic		P2 Control Standard (vs. CSM Classic)		CSM Strawberry Flavor		P2 Control Standard (vs. CSM Strawberry Flavor)		All Study Participants
Arm/Group Description	All participants with evaluable data for CSM Classic vs P2 Control pairwise comparison.		All participants with evaluable data for CSM Classic vs P2 Control pairwise comparison.		All participants with evaluable data for CSM Strawberry Flavor vs P2 Control pairwise comparison.		All participants with evaluable data for CSM Strawberry Flavor vs P2 Control pairwise comparison.		Study participants were randomly assigned to receive a single topical application of 3 study treatments (ChapStick Moisturizer [CSM] Classic; CSM Strawberry Flavor; P2 Control Standard) or no treatment to 4 test sites on the back; 80 +/- 2 milligram (mg) product was applied to each 40 square centimeters [cm^2] test site (2.00 +/- 0.05 mg/cm^2). If there was space for only 3 test sites on the participant's back, only one of the two ChapStick products was evaluated. Test sites received a progressive sequence of timed ultraviolet radiation (UVR) exposures and were evaluated for erythema immediately after irradiation and 16-24 hours (hrs) later. A total of 14 participants were enrolled; up to 4 test sites on the back of each participant were randomized to treatment (2 test products, P2 Control Standard and 1 untreated site used to calculate MEDu). In total, 12 participants were treated with CSM Classic (12 test sites); 10 participants were treated with CSM Strawberry (10 test sites); 14 participants received P2 Control Standard (14 test sites). One participant was excluded from the final CSM Classic vs P2 Control dataset (invalid data: erythema in all sub-sites treated with the test product).
All Cause Mortality
	CSM Classic		P2 Control Standard (vs. CSM Classic)		CSM Strawberry Flavor		P2 Control Standard (vs. CSM Strawberry Flavor)		All Study Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/10 (0%)		0/10 (0%)		0/14 (0%)
Serious Adverse Events
	CSM Classic		P2 Control Standard (vs. CSM Classic)		CSM Strawberry Flavor		P2 Control Standard (vs. CSM Strawberry Flavor)		All Study Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/10 (0%)		0/10 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	CSM Classic		P2 Control Standard (vs. CSM Classic)		CSM Strawberry Flavor		P2 Control Standard (vs. CSM Strawberry Flavor)		All Study Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/10 (0%)		0/10 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.