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

Henry Ford Health System32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Pigmentation

Interventions

Topical Product AOTHER

topical application sunscreen containing topical antioxidants and sunscreen filters

Topical Product BOTHER

topical application of product A without topical antioxidants

Topical Product COTHER

Topical application of antioxidants only

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Henry Ford Hospital

Detroit, Michigan, United States

Outcomes

Primary Outcomes

diffuse reflectance spectroscopy

Diffuse reflectance spectroscopy is a non-invasive objective measure of pigmentation based on reflectance patterns of the irradiated skin

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 24 hours after irradiation to assess persistent pigment darkening

Investigator's global assessment score

Time frame: 24 hours after irradiation to assess persistent pigment darkening

Data from ClinicalTrials.gov

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