Clinical Study to Evaluate the Sun Protection Factor (SPF) of Sunscreen Products

NCT05085327 | Completed Results

• 1 other identifier: 218003
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the static SPF of three sunscreen products (ChapStick Lip Moisturizer \[CLM\] Original, CLM Mint Flavour and CLM Black Cherry Flavour) using the methodology described in the Food and Drug Administration (FDA) Final Rule (2011).

Conditions

Sunscreening Agents

Outcome Measures

Primary Outcomes (1)

• Arithmetic Mean SPF Values

  SPF values for each test product and the SPF standard were first calculated for each individual participant: SPFi = MEDp/MEDuR (p=protected \[treated\] site; u=unprotected \[untreated\] site). The arithmetic mean SPF, standard deviation (SD) and standard error (SE) were then calculated separately for each test product and the SPF standard from valid SPFi data: SPF = (∑SPFi)/n; SD = √\[(∑SPFi\^2) - ((∑SPFi)\^2/n) / (n-1))\]; SE = SD/√n (n = no. participants providing valid test results). For SPF determination to be considered valid, in compliance with FDA Final Rule 2011, the mean 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). The 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.

  From 16 to 24 hours post UV exposure

Study Arms (4)

ChapStick Lip Moisturizer Original

EXPERIMENTAL

Single topical application: 80 +/- 2 milligrams (mg) (2.0 +/- 0.05 mg per square centimeter \[mg/cm\^2\]) of ChapStick Lip Moisturizer Original will be applied to the assigned test site using a fingercot. Test material will be evenly spread over the test site using light pressure for 35 +/- 15 seconds.

Drug: ChapStick Lip Moisturizer Original

ChapStick Lip Moisturizer Mint

EXPERIMENTAL

Single topical application: 80 +/- 2 mg (2.0 +/- 0.05 mg/cm\^2) of ChapStick Lip Moisturizer Mint will be applied to the assigned test site using a fingercot. Test material will be evenly spread over the test site using light pressure for 35 +/- 15 seconds.

Drug: ChapStick Lip Moisturizer Mint

ChapStick Lip Moisturizer Black Cherry

EXPERIMENTAL

Single topical application: 80 +/- 2 mg (2.0 +/- 0.05 mg/cm\^2) of ChapStick Lip Moisturizer Black Cherry will be applied to the assigned test site using a fingercot. Test material will be evenly spread over the test site using light pressure for 35 +/- 15 seconds.

Drug: ChapStick Lip Moisturizer Black Cherry

SPF Standard

ACTIVE COMPARATOR

Single topical application: 80 +/- 2 mg (2.0 +/- 0.05 mg/cm\^2) of SPF Standard will be applied to the assigned test site using a fingercot. Test material will be evenly spread over the test site using light pressure for 35 +/- 15 seconds.

Drug: SPF Standard Sunscreen

Interventions

ChapStick Lip Moisturizer Original DRUG

Sunscreen lip balm.

ChapStick Lip Moisturizer Original

ChapStick Lip Moisturizer Mint DRUG

Sunscreen lip balm.

ChapStick Lip Moisturizer Mint

ChapStick Lip Moisturizer Black Cherry DRUG

Sunscreen lip balm.

ChapStick Lip Moisturizer Black Cherry

SPF Standard Sunscreen DRUG

SPF Standard (7 percent \[%\] Padimate-O and 3% Oxybenzone)

SPF Standard

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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 Individual Typology Angle (ITA) value more than (\>)28 degree.
• 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 40 centimeter square (cm\^2) 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 identity \[ID\], 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: Note: A participant is considered to be of child-bearing potential if, in the opinion of the Principle Investigator (PI), they are biologically capable of having children and sexually active.

You may not qualify if:

• 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 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 (for example, lotions, sunscreens, sunless tanners) and/or topical medications in/on the test area within 24 hours of Study Day 1.
• Participant who is unwilling to cease use of personal care products (for example, 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) (for example, Human Immunodeficiency Virus \[HIV\], Sexually Transmitted Diseases \[STD's\], Hepatitis B, Hepatitis C, and so on)
• 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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

GSK Investigational Site

Winston-Salem, North Carolina, 27101, United States

Location

Results Point of Contact

• Title: Haleon Response Center
• Organization: HALEON

ww.clinical-trial-register@haleon.com

+44 7880 182593

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the outcomes (erythema) assessor is blinded to treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: October 19, 2021
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: March 25, 2024
• Results First Posted: March 25, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoint 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.

Locations

US (1)