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To assess the level of sub pigmentation following an acute exposure to a Deep Ultraviolet A and high energy Blue Light wavelengths (380-420 nm). This study will compare the unprotected control with test products in Condition #1 and Condition #2 to assess pigmentation as well as cutaneous oxidative stress and inflammation biomarkers that occur with exposure to the same light regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects (Condition #1) | Experimental | A trained designee will mark four test sites on the subject's back. Each test site will contain seven subsites: one on-irradiated control (subsite 1) and six subsites (subsites 2-7) designated for increasing light-radiation doses. At Visit 1, the IPs will be applied under Condition #1. Test site 1 will remain unprotected. |
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| All Subjects (Condition #2) | Experimental | At Visit 2, Sunscreen A will be applied to test site 4 under Condition #2. Test site 1 will remain unprotected. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunscreen application #1 | Other | At Visit 1, the IPs will be applied under Condition #1. After 24 hours, the test site will be cleaned, the same IP will be reapplied directly to the test site and allowed to air dry before irradiation. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation of pigmentation | Percent mean change from baseline analysis and comparison between test sites and between subsites . | Visit 2/Day 2 (15 Minutes Post-Irradiation timepoint only) and Visit 3 (18-22 Hours Post-Irradiation). |
| Measure | Description | Time Frame |
|---|---|---|
| SkinColorCatch measurements | Percent mean change from baseline analysis and comparison between test sites and between subsites | Visit 1/Day1, Visit 2/Day2 (Pre- irradiation and 15 Minutes Post-Irradiation), and Visit 3/Day 3 (18-22 Hours Post-Irradiation). |
| Imaging of test sites |
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Inclusion Criteria:
Exclusion Criteria:
Has known allergies or adverse reactions to latex, common topical skincare products, UV light, or ingredients in the ISMs.
Has a history of abnormal responses to sunlight or UV radiation.
Has been instructed by a physician, pharmacist, or health professional to avoid sunlight because of a medical condition and/or because of drug contraindications.
Has a history of photosensitivity (a reaction to sunlight) disorders (including solar urticaria [hives], phototoxicity, photo-allergy, polymorphous light eruptions).
Is regularly taking a medication with photosensitizing potential, such as high blood pressure medication, acne medications (e.g., Accutane), certain psychiatric medications (e.g., Thorazine, tricyclic anti-depressants), certain antibiotics (e.g., Cipro, tetracycline), antihistamines (e.g., Benadryl), Levulan, or Psoralen.
Is regularly taking other medication that could affect the results of the study (e.g., corticosteroids, steroidal or nonsteroidal anti-inflammatory drugs [NSAIDs], antihypertensive drugs, steroid inhalers, drugs that induce skin coloring, etc.). Low dose aspirin (≤81mg per day) is acceptable.
Has used a tanning bed/lamp, has had extended sun exposure of the test area (the lower back), or has participated in a UV exposure study within 4 weeks before Visit 1.
Has a concurrent illness, a medical history of a disease/condition, or a pre-existing/dormant dermatologic condition (e.g., psoriasis, rashes, eczema, seborrheic, severe excoriations, skin infection [fungal, bacterial, or viral], etc.) that could interfere with the outcome of the study or increase health risk to the subject, as determined by the PI or designee.
Via visible light and Wood's lamp evaluation: presence of sunburn, suntan, scars, tattoos, active dermal lesions, nevi, blemishes, moles, excessive tan spots from prior sunscreen testing, excessive hair, or uneven skin tone on the test area (back) that might interfere with the study.
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 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:
Has a personal or family history of skin cancer.
Has skeletal protrusions and/or extreme areas of curvature in the test area.
Is self-reported to be pregnant, lactating, or planning to become pregnant during the study or within 30 days of study completion.
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 .
Has shaved, waxed, and/or used any hair removal method on the test area (back) within 2 weeks before visit 1.
Has applied any leave on product(s) on the test area within 24 hours before Visit 1.
Is simultaneously participating in any other clinical study or has participated in any product-use study within 30 days prior to Visit 1.
Has started a long-term medication within the last 2 months.
Has started hormone replacement therapies (HRT) or hormones for birth control or menopause less than 3 months before study enrollment or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
Is an employee/contractor of the PI, Study Site, or Sponsor or immediate family member of the PI, Study Site Personnel, or Sponsor
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS North America, Inc. - Union Research Center | Union | New Jersey | 07083 | United States |
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| Sunscreen application #2 | Other | At Visit 2, Sunscreen A will be applied to site 4 under Condition #2. The site will air dry before irradiation. |
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Percent mean change from baseline analysis and comparison between test sites and between subsites |
| Visit 2/Day 2 (15 Minutes Post-Irradiation timepoint only) and Visit 3/Day 3(18-22 Hours Post-Irradiation). |
| Tape stripping for protein analyses | Percent mean change from baseline analysis and comparison between test sites and between subsites. | Visit 3/Day 3 (18-22 Hours Post-Irradiation) |
| Skin swabbing for cutaneous biomarkers | Percent mean change from baseline analysis and comparison between test sites and between subsites. | Visit 3/Day 3 (18-22 Hours Post-Irradiation |