Pigmentation Clinical Trial
Official title:
The Effect of Topical Sunscreen Plus Antioxidant Against the Visible Light Biological Effects
Verified date | February 2022 |
Source | Henry Ford Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | Henry Ford Hospital | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Henry Ford Health System | Allergan |
United States,
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
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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