Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunscreen A | Experimental | 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. |
|
| Sunscreen B | Experimental | 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. |
|
| Sunscreen C | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunscreen A | Other | 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. |
| 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS North America Inc. - Union Research Center | Union | New Jersey | 07083 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sunscreen B | Other | 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. |
|
| Sunscreen C | Other | 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. |
|