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

• ClinicalTrials.gov Identifier: NCT04749459
• Recruitment Status: Completed
• First Posted: February 11, 2021
• Results First Posted: March 16, 2022
• Last Update Posted: March 16, 2022
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

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	Not Applicable

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 (Clinical Trial)
• 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: March 3, 2021
• Actual Primary Completion Date: March 31, 2021
• Actual Study Completion Date: March 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

United States, New Jersey

GSK Investigational Site

Fairfield, New Jersey, United States, 07004

Sponsors and Collaborators

GlaxoSmithKline

  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:

Study Protocol and Statistical Analysis Plan  [PDF] January 25, 2021

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT04749459
• Other Study ID Numbers: 215232
• First Posted: February 11, 2021
• Results First Posted: March 16, 2022
• Last Update Posted: March 16, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Sunscreening Agents; Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Dermatologic Agents