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

Pigmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065582
• Other study ID #: IRB # 9695
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Pigmentation

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