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

Study Overview
=================
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).

Detailed Description
-----------------
A single-center, randomized, controlled, intra-individual comparison, evaluator-blind, clinical study to determine the SPF of three sunscreen lip balms. Each participant will evaluate the three test products, an SPF standard and no treatment. Study treatments will be randomly assigned to 5 test sites delineated on the skin of the participant's back. Test sites will be exposed to doses of ultraviolet (UV) radiation and erytemal response evaluated 16-24 hours later. Minimal erythema dose (MED) will be determined for protected and unprotected sites and used to determine the SPF value of each test product.

Official Title
-----------------
Clinical Evaluation of the Sun Protection Factor (SPF) of Sunscreen Products According to the FDA Final Rule: Sunscreen Drug Products (2011)

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: ChapStick Lip Moisturizer Original
* Drug: ChapStick Lip Moisturizer Mint Flavour
* Drug: ChapStick Lip Moisturizer Black Cherry Flavour
* Drug: SPF Standard Sunscreen


Participation Criteria
=================
Eligibility Criteria
-----------------
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 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. 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 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. 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. 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.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ChapStick Lip Moisturizer Original<br>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<br>* Sunscreen lip balm.<br>|
| Experimental: ChapStick Lip Moisturizer Mint Flavour<br>Single topical application: 80 +/- 2 mg (2.0 +/- 0.05 mg/cm^2) of ChapStick Lip Moisturizer Mint Flavour 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 Flavour<br>* Sunscreen lip balm.<br>|
| Experimental: ChapStick Lip Moisturizer Black Cherry Flavour<br>Single topical application: 80 +/- 2 mg (2.0 +/- 0.05 mg/cm^2) of ChapStick Lip Moisturizer Black Cherry Flavour 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 Flavour<br>* Sunscreen lip balm.<br>|
| Active Comparator: SPF Standard<br>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<br>* SPF Standard (7 percent [%] Padimate-O and 3% Oxybenzone)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values | Arithmetic mean of all valid SPFi values of each product on each participant will be calculated from the individual Minimal Erythemal Dose (MED) on product treated (MEDp) test sites in relation to unprotected (MEDu) test sites 16-24 hours after exposure to UV radiation. SPFi = MEDp/MEDu. The MED is defined as the lowest dose of UV radiation that produces the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure. The exposure shall be increased in geometric progression with 25% dose increment in relation to the expected SPF values. All individual SPF values will be converted arithmetically to calculate SPF of test material (or control standard). | Up to 24 hours post UV exposure |