Pigmentation
Conditions
Brief summary
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.
Interventions
OTHERTopical Product A
topical application sunscreen containing topical antioxidants and sunscreen filters
OTHERTopical Product B
topical application of product A without topical antioxidants
OTHERTopical Product C
Topical application of antioxidants only
OTHERControl
No product applied
Sponsors
Allergan
Henry Ford Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diffuse reflectance spectroscopy | Baseline- immediately after irradiation to assess immediate pigment darkening | Diffuse reflectance spectroscopy is a non-invasive objective measure of pigmentation based on reflectance patterns of the irradiated skin |
| photography | Baseline-immediately after irradiation to assess immediate pigment darkening | Cross polarized photography is used to document pigmentation non-invasively and reduce surface glare of the skin. |
| investigator's global assessment score | Baseline- Immediately after irradiation to assess immediate pigment darkening | 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. |
| Diffuse reflectance spectroscopy | 24 hours after irradiation to assess persistent pigment darkening | Diffuse reflectance spectroscopy is a non-invasive objective measure of pigmentation based on reflectance patterns of the irradiated skin |
| Investigator's global assessment score | 24 hours after irradiation to assess persistent pigment darkening | 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. |
| Photography | 7 days after irradiation to assess delayed tanning | Cross polarized photography is used to document pigmentation non-invasively and reduce surface glare of the skin. |
| Investigator global assessment score | 7 days after irradiation to assess delayed tanning | 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. |
| Biological effects | 24 hours after irradiation | biopsy with melanocyte and melanin stains to assess pigmentation |
Countries
United States
Outcome results
None listed