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

Not Applicable

Completed

• Conditions: Pigmentation
• Interventions: Other: Topical Product A; Other: Topical Product B; Other: Topical Product C; Other: Control

• Registration Number: NCT03065582
• Lead Sponsor: Henry Ford Health System

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-02-22
• Study First Posted: 2017-02-28
• Study Start: 2018-03-13
• Primary Completion: 2018-09-15
• Study Completion: 2019-04-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sunscreen application	Topical Product B	All subjects will undergo topical application of 3 products and an additional site will serve as a control
Sunscreen application	Topical Product A	All subjects will undergo topical application of 3 products and an additional site will serve as a control
Sunscreen application	Topical Product C	All subjects will undergo topical application of 3 products and an additional site will serve as a control
Sunscreen application	Control	All subjects will undergo topical application of 3 products and an additional site will serve as a control

Primary Outcome Measures

Name	Time	Method
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
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.
photography	24 hours after irradiation to assess persistent pigment darkening	Cross polarized photography is used to document pigmentation non-invasively and reduce surface glare of the skin.
Diffuse reflectance spectroscopy	7 days after irradiation to assess delayed tanning	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.
Biological effects	24 hours after irradiation	biopsy with melanocyte and melanin stains to assess pigmentation
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.

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States