The Effect of Topical Sunscreen Plus Antioxidant Against the Visible Light Biological Effects
15. februar 2022 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
32
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Michigan
-
Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
diffuse reflectance spectroscopy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 24 hours after irradiation
|
biopsy with melanocyte and melanin stains to assess pigmentation
|
24 hours after irradiation
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Iltefat Hamzavi, MD, Henry Ford Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
13. marts 2018
Primær færdiggørelse (Faktiske)
15. september 2018
Studieafslutning (Faktiske)
22. april 2019
Datoer for studieregistrering
Først indsendt
30. januar 2017
Først indsendt, der opfyldte QC-kriterier
22. februar 2017
Først opslået (Faktiske)
28. februar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. marts 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. februar 2022
Sidst verificeret
1. februar 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- IRB # 9695
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
IPD-planbeskrivelse
No individual participant data will be available to other researchers.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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