N/A
N=11
Clinical Study to Evaluate the Sun Protection Factor (SPF) of Sunscreen Products
Sunscreening Agents
Bottom Line
View on ClinicalTrials.gov: NCT05085327 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Arithmetic Mean SPF Values — 13.9; 16.1; 14.3; 15.8 Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ChapStick Lip Moisturizer Original (Drug); ChapStick Lip Moisturizer Mint (Drug); ChapStick Lip Moisturizer Black Cherry (Drug); SPF Standard Sunscreen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HALEON
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arithmetic Mean SPF Values |
13.9; 16.1; 14.3; 15.8; 14.8; 16.1 | — |
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).
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 sk
Data sourced from ClinicalTrials.gov (NCT05085327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.