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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03065582
Other study ID # IRB # 9695
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 13, 2018
Est. completion date April 22, 2019

Study information

Verified date February 2022
Source Henry Ford Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date April 22, 2019
Est. primary completion date September 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Topical Product A
topical application sunscreen containing topical antioxidants and sunscreen filters
Topical Product B
topical application of product A without topical antioxidants
Topical Product C
Topical application of antioxidants only
Control
No product applied

Locations

Country Name City State
United States Henry Ford Hospital Detroit Michigan

Sponsors (2)

Lead Sponsor Collaborator
Henry Ford Health System Allergan

Country where clinical trial is conducted

United States, 

References & Publications (10)

Boukari F, Jourdan E, Fontas E, Montaudié 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Porges SB, Kaidbey KH, Grove GL. Quantification of visible light-induced melanogenesis in human skin. Photodermatol. 1988 Oct;5(5):197-200. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Biological effects biopsy with melanocyte and melanin stains to assess pigmentation 24 hours after irradiation
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