Clinical Study to Evaluate the Efficacy of an Over-the-counter (OTC) Sunscreen Lip Balm Product

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the 8-hour moisturization efficacy of OTC sunscreen lip balm after a single treatment application.

Detailed Description
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A single-center, randomized, controlled, intra-individual comparison, open label clinical study to determine the 8-hour moisturization efficacy of a sunscreen lip balm. Skin hydration will be assessed before (Baseline) and after (2, 4, 6 and 8 hours post-treatment) a single treatment with test product, compared to 'no treatment' as control, using a corneometer. Study treatments will be randomly assigned to 2 test sites delineated on the skin of the participant's volar forearms (one test site on each arm). A 1-week conditioning phase will precede the test day, during which participants will use the soap provided for personal washing.

Official Title
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A Clinical Study to Evaluate the 8-Hour Moisturization Efficacy of an Over-The-Counter Sunscreen Lip Balm After a Single Application

Conditions
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Sunscreening Agents

Intervention / Treatment
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* Drug: ChapStick Active Performance Unscented


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must provide a signed and dated, legally effective, informed consent document, which indicates they have been informed of, and understand, all pertinent aspects of the study, before any study procedures are performed (in conformance with 21 Code of Federal Regulations [CFR] Part 50: 'Protection of Human Subjects.') Participant must provide relevant details of their medical history and current/recent medications and treatments. Participant has completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45 CFR Parts 160 and 164. 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 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 treatment application. (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. Participant must agree to be sequestered in a temperature/humidity monitored test room at the clinical site (temperature 21 degree Celsius [C] +/- 2 degree C, relative humidity [RH] 50 percent [%] +/- 10%) for the duration of the test day (Visit 2), approximately 9.5 hours. Participant must agree to bring their own food (dry) and beverages to be consumed on the test day (Visit 2). Participant must agree not to consume hot or very cold food/beverages on the test day (Visit 2). Participant must agree to use the non-moisturizing soap provided for all personal washing during the conditioning phase of the study. Participant must agree to wear loose clothing for ease of access to the test sites (arms) and/or sleeves that can be easily rolled up. Participant must agree not to introduce any new cosmetic/toiletry products into their personal care regimen during the study. Participant must agree to refrain from any physical effort which might result in thermal regulation by sweating (for example, exercise class, rapid climbing of flights of stairs, jogging, cycling, brisk walking) for at least 2 hours prior to arriving the test day (Visit 2). Participant must agree to refrain from prolonged or excessive ultraviolet (UV) exposure (for example, sunbathing, tanning beds) for the duration of the study. Participant should be dependable and able to follow directions as outlined in the protocol and Informed Consent Form (ICF). Exclusion Criteria: Participant with scheduled or planned Covid-19 vaccination during likely dates of study participation. Female participant who is pregnant, planning to become pregnant during the study, or breastfeeding ( self-reported). Participant with a history of sensitivity to any ingredient of the test material or skin marker pen, or latex; or any known sensitivities/allergies, including but not limited to cosmetic/toiletry products and topically applied skin treatment products/drugs. Participant with a history of an acute or chronic dermatologic, medical and/or physical condition that would, in the opinion of the investigator, confound study outcomes or increase the risk associated with participation. (Note: dry skin is not an exclusion per se; however, a participant with a level of dryness on the skin of the volar forearms that would, in the opinion of the investigator, confound study outcomes or increase the risk associated with participation should be excluded. Participant with a history of skin cancer, or currently undergoing treatment for active cancer of any kind. Participant with diabetes. Participant with a planned medical treatment/vaccination (other than the Covid-19 vaccination) during the study that would, in the opinion of the investigator, confound study outcomes or increase the risk associated with participation. Participant with a planned hospitalization during the study. Participant who is currently using, or has used in the past week, any systemic or topical corticosteroid, non-steroid anti-inflammatory drug, antihistamine, sympathomimetic, and/or vasoconstrictor or any other medication that would, in the opinion of the investigator, confound study outcomes or increase the risk associated with participation. Participant who is unwilling to cease use of personal care products (for example, moisturizers, lotions, sunscreens, sunless tanners) and/or topical medications at the test sites for the duration of the study. Participant who has had extensive UV exposure within 3 weeks of Screening (Visit 1). Participant with visual signs of irritation, sunburn, rashes, scratches, burn marks, scarring at the test sites that would interfere with corneometry measurements. Participant with excessive hair at the test sites that would interfere with corneometry measurements. Participant who has participated in a study involving the arms as a test site, or any other type of clinical study, within three weeks of screening (Visit 1). Participant who is an employee/contractor or immediate family member of the PI, study site or Sponsor.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Arm<br>Single topical application: 80 +/- 2 milligrams (mg) (2.0 +/- 0.05 mg/centimeter^2) of ChapStick Active Performance Unscented will be applied to the assigned test site using a fingercot. The test product will be evenly spread over the test site using light pressure. | Drug: ChapStick Active Performance Unscented<br>* Sunscreen lip balm.<br>|
| No Intervention: Control Arm<br>No treatment will be applied to the assigned control site. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from Baseline in Corneometry Measurements | Corneometry is an instrumental technique designed to measure changes in the capacitance of the skin resulting from changes in the degree of hydration; it is particularly sensitive to low hydration levels. Corneometry uses a capacitance sensor to measure the dielectric constant of the outer layers of the skin (stratum corneum). The dielectric constant is directly proportional to the water content of the skin (skin hydration). The capacitance of the skin surface is expressed in arbitrary units of skin hydration; the higher the corneometer reading, the more hydrated (moist) the skin. The mean of the 3 corneometer measurements obtained for each test site at each time point will be calculated for each participant. Change from Baseline will be calculated as post-Baseline assessment value minus the Baseline assessment value. | Baseline and 2, 4, 6 and 8 hours post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of participants improved | Percent participants improved will be calculated at each post-treatment timepoint as the number of participants who exhibited improvement (positive change) divided by the total number of participants included in the analysis. | Baseline and 2, 4, 6 and 8 hours post-treatment |