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

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 Overview

• Status: Completed
• Conditions: Pigmentation
• Intervention / Treatment: Other: Topical Product A; Other: Topical Product B; Other: Topical Product C; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: Allergan
• Investigators: Principal Investigator: Iltefat Hamzavi, MD, Henry Ford Hospital

Publications and helpful links

General Publications

• Mahmoud BH, Ruvolo E, Hexsel CL, Liu Y, Owen MR, Kollias N, Lim HW, Hamzavi IH. Impact of long-wavelength UVA and visible light on melanocompetent skin. J Invest Dermatol. 2010 Aug;130(8):2092-7. doi: 10.1038/jid.2010.95. Epub 2010 Apr 22.
• Porges SB, Kaidbey KH, Grove GL. Quantification of visible light-induced melanogenesis in human skin. Photodermatol. 1988 Oct;5(5):197-200.
• Mahmoud BH, Hexsel CL, Hamzavi IH, Lim HW. Effects of visible light on the skin. Photochem Photobiol. 2008 Mar-Apr;84(2):450-62. doi: 10.1111/j.1751-1097.2007.00286.x. Epub 2008 Jan 29.
• Kollias N, Baqer A. An experimental study of the changes in pigmentation in human skin in vivo with visible and near infrared light. Photochem Photobiol. 1984 May;39(5):651-9. doi: 10.1111/j.1751-1097.1984.tb03905.x. No abstract available.
• Duteil L, Cardot-Leccia N, Queille-Roussel C, Maubert Y, Harmelin Y, Boukari F, Ambrosetti D, Lacour JP, Passeron T. Differences in visible light-induced pigmentation according to wavelengths: a clinical and histological study in comparison with UVB exposure. Pigment Cell Melanoma Res. 2014 Sep;27(5):822-6. doi: 10.1111/pcmr.12273. Epub 2014 Jul 25.
• Yakes FM, Van Houten B. Mitochondrial DNA damage is more extensive and persists longer than nuclear DNA damage in human cells following oxidative stress. Proc Natl Acad Sci U S A. 1997 Jan 21;94(2):514-9. doi: 10.1073/pnas.94.2.514.
• Boukari F, Jourdan E, Fontas E, Montaudie H, Castela E, Lacour JP, Passeron T. Prevention of melasma relapses with sunscreen combining protection against UV and short wavelengths of visible light: a prospective randomized comparative trial. J Am Acad Dermatol. 2015 Jan;72(1):189-90.e1. doi: 10.1016/j.jaad.2014.08.023. Epub 2014 Oct 22. No abstract available.
• Wang SQ, Osterwalder U, Jung K. Ex vivo evaluation of radical sun protection factor in popular sunscreens with antioxidants. J Am Acad Dermatol. 2011 Sep;65(3):525-530. doi: 10.1016/j.jaad.2010.07.009. Epub 2011 May 31.
• Kunisada M, Sakumi K, Tominaga Y, Budiyanto A, Ueda M, Ichihashi M, Nakabeppu Y, Nishigori C. 8-Oxoguanine formation induced by chronic UVB exposure makes Ogg1 knockout mice susceptible to skin carcinogenesis. Cancer Res. 2005 Jul 15;65(14):6006-10. doi: 10.1158/0008-5472.CAN-05-0724.
• Herrling T, Jung K, Fuchs J. Measurements of UV-generated free radicals/reactive oxygen species (ROS) in skin. Spectrochim Acta A Mol Biomol Spectrosc. 2006 Mar 13;63(4):840-5. doi: 10.1016/j.saa.2005.10.013.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2018
• Primary Completion (Actual): September 15, 2018
• Study Completion (Actual): April 22, 2019

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB # 9695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No individual participant data will be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No