The Effect of Topical Sunscreen Plus Antioxidant Against the Visible Light Biological Effects
15 februari 2022 uppdaterad av: Iltefat Hamzavi, Henry Ford Health System
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
32
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Michigan
-
Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Sunscreen application
All subjects will undergo topical application of 3 products and an additional site will serve as a control
|
topical application sunscreen containing topical antioxidants and sunscreen filters
topical application of product A without topical antioxidants
Topical application of antioxidants only
No product applied
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
diffuse reflectance spectroscopy
Tidsram: Baseline- immediately after irradiation to assess immediate pigment darkening
|
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
Tidsram: Baseline-immediately after irradiation to assess immediate pigment darkening
|
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
Tidsram: Baseline- Immediately after irradiation to assess immediate pigment darkening
|
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
Tidsram: 24 hours after irradiation to assess persistent pigment darkening
|
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
Tidsram: 24 hours after irradiation to assess persistent pigment darkening
|
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
Tidsram: 24 hours after irradiation to assess persistent pigment darkening
|
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
|
|
Diffuse reflectance spectroscopy
Tidsram: 7 days after irradiation to assess delayed tanning
|
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
Tidsram: 7 days after irradiation to assess delayed tanning
|
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
Tidsram: 7 days after irradiation to assess delayed tanning
|
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
Tidsram: 24 hours after irradiation
|
biopsy with melanocyte and melanin stains to assess pigmentation
|
24 hours after irradiation
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Iltefat Hamzavi, MD, Henry Ford Hospital
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- Porges SB, Kaidbey KH, Grove GL. Quantification of visible light-induced melanogenesis in human skin. Photodermatol. 1988 Oct;5(5):197-200.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
13 mars 2018
Primärt slutförande (Faktisk)
15 september 2018
Avslutad studie (Faktisk)
22 april 2019
Studieregistreringsdatum
Först inskickad
30 januari 2017
Först inskickad som uppfyllde QC-kriterierna
22 februari 2017
Första postat (Faktisk)
28 februari 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 mars 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 februari 2022
Senast verifierad
1 februari 2022
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- IRB # 9695
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
IPD-planbeskrivning
No individual participant data will be available to other researchers.
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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