Clinical trial NCT03065582: The Effect of Topical Sunscreen Plus Antioxidant Against the Visible Light Biological Effects
Official title: The Effect of Topical Sunscreen Plus Antioxidant Against the Visible Light Biological Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pigmentation
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2017-02-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: diffuse reflectance spectroscopy
timeFrame: Baseline- immediately after irradiation to assess immediate pigment darkening
measure: photography
timeFrame: Baseline-immediately after irradiation to assess immediate pigment darkening
measure: investigator's global assessment score
timeFrame: Baseline- Immediately after irradiation to assess immediate pigment darkening
measure: Diffuse reflectance spectroscopy
timeFrame: 24 hours after irradiation to assess persistent pigment darkening
measure: photography
timeFrame: 24 hours after irradiation to assess persistent pigment darkening
measure: Investigator's global assessment score
timeFrame: 24 hours after irradiation to assess persistent pigment darkening
measure: Diffuse reflectance spectroscopy
timeFrame: 7 days after irradiation to assess delayed tanning
measure: Photography
timeFrame: 7 days after irradiation to assess delayed tanning
measure: Investigator global assessment score
timeFrame: 7 days after irradiation to assess delayed tanning
measure: Biological effects
timeFrame: 24 hours after irradiation
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Hospital
name: Iltefat Hamzavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1111/j.1751-1097.1984.tb03905.x. No abstract available.
citation: Porges SB, Kaidbey KH, Grove GL. Quantification of visible light-induced melanogenesis in human skin. Photodermatol. 1988 Oct;5(5):197-200.
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.
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.
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. doi: 10.1073/pnas.94.2.514.
citation: 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.
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.
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. doi: 10.1158/0008-5472.CAN-05-0724.
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. doi: 10.1016/j.saa.2005.10.013.