The Effect of Topical Sunscreen Plus Antioxidant Against the Visible Light Biological Effects

Study Overview
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Brief Summary
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Visible light is known to induce pigmentation in darker skin types. The investigators aim to study the effects of visible light on the skin after topical application of sunscreen plus antioxidant.

Official Title
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The Effect of Topical Sunscreen Plus Antioxidant Against the Visible Light Biological Effects

Conditions
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Pigmentation

Intervention / Treatment
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* Other: Topical Product A
* Other: Topical Product B
* Other: Topical Product C
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age 18 and older Patients Fitzpatrick skin phototype IV-VI Patient able to understand requirements of the study and risks involved Patient able to sign a consent form Exclusion Criteria: A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation A known history of photodermatoses A known history of melanoma or non-melanoma skin cancers Those planning on going to the tanning parlors Using any of the photosensitizing medication within the visible light range or additional medications at the discretion of the investigator (examples include (but not limited to) thiazide diuretics, regular use of NSAIDs, hydroxychloroquine, or voriconazole) A woman who is lactating, pregnant, or planning to become pregnant Patient planning on exposing the irradiated or control areas to the sun known allergy to anesthetics (lidocaine or epinephrine)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunscreen application<br>All subjects will undergo topical application of 3 products and an additional site will serve as a control | Other: Topical Product A<br>* topical application sunscreen containing topical antioxidants and sunscreen filters<br>Other: Topical Product B<br>* topical application of product A without topical antioxidants<br>Other: Topical Product C<br>* Topical application of antioxidants only<br>Other: Control<br>* No product applied<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diffuse reflectance spectroscopy | Diffuse reflectance spectroscopy is a non-invasive objective measure of pigmentation based on reflectance patterns of the irradiated skin | Baseline- immediately after irradiation to assess immediate pigment darkening | 
| photography | Cross polarized photography is used to document pigmentation non-invasively and reduce surface glare of the skin. | Baseline-immediately after irradiation to assess immediate pigment darkening | 
| investigator's global assessment score | The investigator's global assessment score is a non-invasive subjective measure of pigmentation in which investigators assign a value ranging between 0, corresponding with no hyperpigmentation, to 5, or severe or dark hyperpigmentation. | Baseline- Immediately after irradiation to assess immediate pigment darkening | 
| Diffuse reflectance spectroscopy | Diffuse reflectance spectroscopy is a non-invasive objective measure of pigmentation based on reflectance patterns of the irradiated skin | 24 hours after irradiation to assess persistent pigment darkening | 
| photography | Cross polarized photography is used to document pigmentation non-invasively and reduce surface glare of the skin. | 24 hours after irradiation to assess persistent pigment darkening | 
| Investigator's global assessment score | The investigator's global assessment score is a non-invasive subjective measure of pigmentation in which investigators assign a value ranging between 0, corresponding with no hyperpigmentation, to 5, or severe or dark hyperpigmentation. | 24 hours after irradiation to assess persistent pigment darkening | 
| Diffuse reflectance spectroscopy | Diffuse reflectance spectroscopy is a non-invasive objective measure of pigmentation based on reflectance patterns of the irradiated skin | 7 days after irradiation to assess delayed tanning | 
| Photography | Cross polarized photography is used to document pigmentation non-invasively and reduce surface glare of the skin. | 7 days after irradiation to assess delayed tanning | 
| Investigator global assessment score | The investigator's global assessment score is a non-invasive subjective measure of pigmentation in which investigators assign a value ranging between 0, corresponding with no hyperpigmentation, to 5, or severe or dark hyperpigmentation. | 7 days after irradiation to assess delayed tanning | 
| Biological effects | biopsy with melanocyte and melanin stains to assess pigmentation | 24 hours after irradiation |