The Effect of Topical Sunscreen Plus Antioxidant Against the Visible Light Biological Effects

NCT03065582 | Completed DMC

• 1 other identifier: IRB # 9695
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pigmentation

Outcome Measures

Primary Outcomes (10)

• 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.

  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

Study Arms (1)

Sunscreen application

EXPERIMENTAL

All subjects will undergo topical application of 3 products and an additional site will serve as a control

Other: Topical Product A; Other: Topical Product B; Other: Topical Product C; Other: Control

Interventions

Topical Product A OTHER

topical application sunscreen containing topical antioxidants and sunscreen filters

Sunscreen application

Topical Product B OTHER

topical application of product A without topical antioxidants

Sunscreen application

Topical Product C OTHER

Topical application of antioxidants only

Sunscreen application

Control OTHER

No product applied

Sunscreen application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Henry Ford Health System: lead
• Allergan: collaborator

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (10)

• 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.

  PMID: 18248499 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.

  PMID: 6739557 BACKGROUND

• Porges SB, Kaidbey KH, Grove GL. Quantification of visible light-induced melanogenesis in human skin. Photodermatol. 1988 Oct;5(5):197-200.

  PMID: 3222167 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.

  PMID: 20410914 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.

  PMID: 24888214 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.

  PMID: 9012815 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.

  PMID: 25443629 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.

  PMID: 21624700 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.

  PMID: 16024598 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.

  PMID: 16543118 BACKGROUND

Study Officials

• Iltefat Hamzavi, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 28, 2017
• Study Start: March 13, 2018
• Primary Completion: September 15, 2018
• Study Completion: April 22, 2019
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)