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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunscreen application | Experimental | All subjects will undergo topical application of 3 products and an additional site will serve as a control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Product A | Other | topical application sunscreen containing topical antioxidants and sunscreen filters |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iltefat Hamzavi, MD | Henry Ford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18248499 | Background | 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. | |
| 6739557 | Background | 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. |
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No individual participant data will be available to other researchers.
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| Topical Product B | Other | topical application of product A without topical antioxidants |
|
| Topical Product C | Other | Topical application of antioxidants only |
|
| Control | Other | No product applied |
|
| 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 |
| 3222167 | Background | Porges SB, Kaidbey KH, Grove GL. Quantification of visible light-induced melanogenesis in human skin. Photodermatol. 1988 Oct;5(5):197-200. |
| 20410914 | Background | 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. |
| 24888214 | Background | 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. |
| 9012815 | Background | 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. |
| 25443629 | Background | 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. |
| 21624700 | Background | 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. |
| 16024598 | Background | 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. |
| 16543118 | Background | 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. |