A Study to Evaluate Usage of Mineral Sunscreens With Differentiated Whitening Attributes in Multi-Cultural Skin Tones

A Single-Center, Randomized, Clinical Study to Evaluate Usage of Facial Mineral Sunscreens With Differentiated Whitening Attributes in Multi-Cultural Skin Tones Through Instrumentation Measurements, Imaging, and Self-Assessments

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

Study Overview

• Status: Completed
• Conditions: Sunscreen
• Intervention / Treatment: Other: Sunscreen A; Other: Sunscreen B; Other: Sunscreen C

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Union, New Jersey, United States, 07083
      • SGS North America Inc. - Union Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 = 15 participants), skin tones "Beige to light tan/light olive" and "Medium tan/medium olive to light brown" (N = 15 participants), skin tones "Medium brown to dark brown and "Darkest brown to darkest black" (N = 15 participants)
• Has a history of using or is a current user of sunscreens
• Is willing to have height and body weight measured and recorded
• Generally in good health based on medical history reported by the participants
• Is able to read, write, speak, and understand English or Spanish
• Has signed the ICD including Health Insurance Portability and Accountability Act (HIPAA) disclosure and Photograph Release
• 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 IPs
• Presents with a skin condition and/or pre-existing or dormant dermatologic disease on the face, volar forearms, or lower legs that may confound the study results (e.g., psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer, rosacea, moderate to severe acne, acne conglobate, nodules, and/or cysts on the face) or interfere with evaluations (e.g., excessive hair, tattoos, scarring, nevi, very uneven skin tone, sunburn, scratches/broken/compromised skin)
• Has had any facial treatments including facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin (Botox), injectable filler treatments, intense pulsed light (IPL), acid treatments, tightening treatments, facial plastic surgery, or any other treatment administered by a physician or skin care professional designed to improve the appearance or firmness of facial skin withing 30 days prior to Visit 1
• Has shaved or used any hair removal method on lower legs or volar forearms within 24 hours of Visit 1
• Has a history of skin cancer within the past 5 years
• 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 confuse the study results
• Has a history of immunosuppression/immune deficiency disorders (including HIV infection, AIDS, multiple sclerosis, Crohn's disease, rheumatoid arthritis), organ transplant (heart, kidney, etc.), and/or undergoing radiation or chemotherapy as determined by study documentation
• Has a disease such as asthma, epilepsy, hypertension, hyperthyroidism, or hypothyroidism that is not controlled by diet or medication. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.
• Is self-reported to be breast feeding, 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, confuse the study results, or interfere significantly with the individual's participation in the study
• Has started any long-term medication within the last 2 months
• Is simultaneously participating in any other clinical study or has participated in any product-use study within 30 days prior to Visit 1
• Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sunscreen A; At each visit, each enrolled subject will be randomly assigned 1 of the 3 Sunscreens to apply to both lower legs (between the knee and ankle) and then her full face. The subject will cleanse her hands with soap and water between the lower legs and face Sunscreen applications. After lower legs and facial Sunscreen applications are completed, a trained designee will delineate six 4 cm x 4 cm test sites on the subject's volar forearms (3 test sites per volar forearm). Then a trained designee will apply the assigned Sunscreen to the designated test sites in a consistent manner at a randomly assigned dose density of 0.25, 0.50, 0.75, 1.00, 1.50, and 2.00 mg/cm2 (± 10%) per the randomization schedule using a 1cc tuberculin syringe (without a needle) or pipette and a clean finger cot for approximately 20 to 50 seconds.	Other: Sunscreen A; Sunscreen A will be applied to both lower legs (between the knee and ankle) and then her full face to the randomly assigned participants at Visit1, Visit 2, and Visit 3.
Experimental: Sunscreen B; At each visit, each enrolled subject will be randomly assigned 1 of the 3 Sunscreens to apply to both lower legs (between the knee and ankle) and then her full face. The subject will cleanse her hands with soap and water between the lower legs and face Sunscreen applications. After lower legs and facial Sunscreen applications are completed, a trained designee will delineate six 4 cm x 4 cm test sites on the subject's volar forearms (3 test sites per volar forearm). Then a trained designee will apply the assigned Sunscreen to the designated test sites in a consistent manner at a randomly assigned dose density of 0.25, 0.50, 0.75, 1.00, 1.50, and 2.00 mg/cm2 (± 10%) per the randomization schedule using a 1cc tuberculin syringe (without a needle) or pipette and a clean finger cot for approximately 20 to 50 seconds.	Other: Sunscreen B; Sunscreen B will be applied to both lower legs (between the knee and ankle) and then her full face to the randomly assigned participants at Visit1, Visit 2, and Visit 3.
Experimental: Sunscreen C; At each visit, each enrolled subject will be randomly assigned 1 of the 3 Sunscreens to apply to both lower legs (between the knee and ankle) and then her full face. The subject will cleanse her hands with soap and water between the lower legs and face Sunscreen applications. After lower legs and facial Sunscreen applications are completed, a trained designee will delineate six 4 cm x 4 cm test sites on the subject's volar forearms (3 test sites per volar forearm). Then a trained designee will apply the assigned Sunscreen to the designated test sites in a consistent manner at a randomly assigned dose density of 0.25, 0.50, 0.75, 1.00, 1.50, and 2.00 mg/cm2 (± 10%) per the randomization schedule using a 1cc tuberculin syringe (without a needle) or pipette and a clean finger cot for approximately 20 to 50 seconds.	Other: Sunscreen C; Sunscreen C will be applied to both lower legs (between the knee and ankle) and then her full face to the randomly assigned participants at Visit1, Visit 2, and Visit 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Instrumentation	Whitening potential of mineral sunscreens across multi-cultural skin tones through instrumentation (Chroma Meter and Polychromatic Hybrid Diffuse Reflectance Spectroscopy measurements) will be reported.	Visit 1 (Day 1), Visit 2 (Day 7) and Visit 3 (Day 14)
Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Imaging	Whitening potential of mineral sunscreens across multi-cultural skin tones through imaging (Full-Face Imaging via VISIA-CR and Volar Forearms Imaging via Digital Camera) will be reported.	Visit 1 (Day1), Visit 2 (Day 7) and Visit 3 (Day 14)
Whitening Potential of Mineral Sunscreens Across Multi-cultural Skin Tones Through Self-assessment	Whitening potential of mineral sunscreens across multi-cultural skin tones through self-assessment will be reported via self-assessment questionnaire.	Visit 1 (Day1), Visit 2 (Day 7) and Visit 3 (Day 14)

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2024
• Primary Completion (Actual): February 14, 2025
• Study Completion (Actual): February 14, 2025

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Dermatologic Agents; Protective Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: CS2024SK100197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No