A Study to Evaluate the Whitening Effect of Mineral Sunscreens in Multi-Cultural Skin Tones

NCT ID: NCT05565625

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-29
• Study Completion Date: 2022-03-30

Brief Summary

The purpose of this study is to evaluate the whitening potential effect of different mineral sunscreens across multi-cultural skin tones through instrumentation, imaging, and self-assessment and also evaluate the relationship between self-perception and objective measurement of whitening.

Conditions

Sunscreen

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sunscreen

Participants will receive two of six sunscreens (A, B, C, D, E, and F) at Visit 1 (Day 1) to apply to whole lower legs (1 sunscreen per lower leg), between the knee and ankle. Participant will then select one of the two sunscreens randomly assigned to lower legs and apply the selected sunscreen to full face. After lower legs and facial applications are completed, a trained designee will delineate six 4 centimeters (cm)\*4 cm test sites on the participants' volar forearms (3 test sites per volar forearm). The six sunscreens will be randomly assigned to the six test sites at a dose of 2.00 +- 0.05 milligrams per centimeter square (mg/cm\^2) using a 1cc tuberculin syringe (without a needle) and a clean finger cot for approximately 20 to 50 seconds and applied by a trained designee.

Group Type: EXPERIMENTAL

Sunscreen A

Intervention Type: OTHER

Participants will topically apply Sunscreen A at Visit 1.

Sunscreen B

Intervention Type: OTHER

Participants will apply Sunscreen B at Visit 1.

Sunscreen C

Intervention Type: OTHER

Participants will apply Sunscreen C at Visit 1.

Sunscreen D

Intervention Type: OTHER

Participants will apply Sunscreen D at Visit 1.

Sunscreen E

Intervention Type: OTHER

Participants will apply Sunscreen E at Visit 1.

Sunscreen F

Intervention Type: OTHER

Participants will apply Sunscreen F at Visit 1.

Interventions

Sunscreen A

Participants will topically apply Sunscreen A at Visit 1.

Intervention Type: OTHER

Sunscreen B

Participants will apply Sunscreen B at Visit 1.

Intervention Type: OTHER

Sunscreen C

Participants will apply Sunscreen C at Visit 1.

Intervention Type: OTHER

Sunscreen D

Participants will apply Sunscreen D at Visit 1.

Intervention Type: OTHER

Sunscreen E

Participants will apply Sunscreen E at Visit 1.

Intervention Type: OTHER

Sunscreen F

Participants will apply Sunscreen F at Visit 1.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Self-reported natural skin tone/skin color, targeting the following: skin tones "Pale/fair to light white" and "White to light beige" (n = 30 participants), skin tones "Beige to light tan/light olive" and "Medium tan/medium olive to light brown" (n = 30 participants), and Skin tones "Medium brown to dark brown" and "darkest brown to darkest black" (n = 30 participants)
• Has a history of using or is a current user of sunscreens
• Generally, in good health based on medical history reported by the participants
• Able to read, write, speak, and understand English
• Individual has signed the consent for photograph release and informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure
• Intends to complete the study and is willing and able to follow all study instructions

Exclusion Criteria

• Has known allergies or adverse reactions to common topical skincare products or ingredients in the ISMs
• Presents with a skin condition on the face, volar forearms, or lower legs that may confound the study results (example, psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer) or interfere with evaluations (example, excessive hair, tattoos, scarring, very uneven skin tone, sunburn, scratches/broken/compromised skin)
• Has shaved or used any hair removal method on lower legs or volar forearms within 24 hours of Visit 1
• Has a history of a confirmed or suspected coronavirus disease 2019 (COVID-19) infection within 30 days prior to the study visit
• Within 14 days prior to Visit 1, has been in close contact (exposure within 6 feet for a cumulative time of 15 minutes or more over a 24-hour period) with anyone who has been infected with COVID-19
• Is under a COVID-19 isolation/quarantine order
• Has experienced any of the following self-reported symptoms of COVID-19 within 2 weeks prior to the study visit: unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomachaches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, or chest pain/tightness; temperature greater than or equal to (>=) 37.5 degrees celsius (C)/99.5 degrees fahrenheit (F), measured; use of fever or pain reducers within 2 days prior to the study visit
• Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
• Is taking a medication that would mask an adverse event (AE) or confound the study results, including: Immunosuppressive or steroidal drugs within 2 months before Visit 1; non-steroidal anti-inflammatory drugs within 5 days before Visit 1; antihistamines within 1 week before Visit 1
• Is self-reported to be pregnant or planning to become pregnant during the study
• Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
• Is simultaneously participating in any other clinical study or has participated in any product-use study within 14 days prior to Visit 1
• Is an employee/contractor or immediate family member of the principle investigator (PI), study site, or sponsor

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Consumer Inc. (J&JCI)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Wrone, M.D., FAAD

Role: PRINCIPAL_INVESTIGATOR

Validated Claim Support (VCS)

Locations

Validated Claim Support (VCS)

Teaneck, New Jersey, United States

Countries

United States

References

Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.

Reference Type: BACKGROUND

PMID: 3377516 (View on PubMed)

U.S. Census Bureau. (n.d.). About race. Retrieved July 27, 2021, from https://www.census.gov/topics/population/race/about.html

Reference Type: BACKGROUND

U.S. Census Bureau. (n.d.). About the Hispanic population and its origin. Retrieved July 27, 2021, from https://www.census.gov/topics/population/hispanic-origin/about.html

Reference Type: BACKGROUND

Wan S, Anderson RR, Parrish JA. Analytical modeling for the optical properties of the skin with in vitro and in vivo applications. Photochem Photobiol. 1981 Oct;34(4):493-9. doi: 10.1111/j.1751-1097.1981.tb09391.x.

Reference Type: BACKGROUND

PMID: 7312955 (View on PubMed)

Mark Ruzon (2021). RGB2Lab (https://www.mathworks.com/matlabcentral/fileexchange/24009-rgb2lab), MATLAB Central File Exchange. Retrieved November 29, 2021.

Reference Type: BACKGROUND

Mosteller RD. Simplified calculation of body-surface area. N Engl J Med. 1987 Oct 22;317(17):1098. doi: 10.1056/NEJM198710223171717. No abstract available.

Reference Type: BACKGROUND

PMID: 3657876 (View on PubMed)

Murari A, Singh KN. Lund and Browder chart-modified versus original: a comparative study. Acute Crit Care. 2019 Nov;34(4):276-281. doi: 10.4266/acc.2019.00647. Epub 2019 Nov 29.

Reference Type: BACKGROUND

PMID: 31795625 (View on PubMed)

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=CCSSKA004479&attachmentIdentifier=803ed870-6959-4ce4-b25a-a19cecb6dc20&fileName=CCSSKA004479_CSR_Synopsis_English.pdf&versionIdentifier=

Redacted CSR Synopsis

Other Identifiers

CCSSKA004479

Identifier Type: OTHER

Identifier Source: secondary_id

CCSSKA004479

Identifier Type: -

Identifier Source: org_study_id