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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Sunscreen

Treatments: Other: Sunscreen B; Other: Sunscreen A; Other: Sunscreen C

Study type: Interventional

Funder types: Industry

Identifiers

NCT06734299

CS2024SK100197

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Sunscreen A

Experimental group

Description:

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.

Treatment:

Other: Sunscreen A

Sunscreen B

Experimental group

Description:

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.

Treatment:

Other: Sunscreen B

Sunscreen C

Experimental group

Description:

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.

Treatment:

Other: Sunscreen C