Vitamin E Prevention of Visible Light Pigmentation

NCT01927679 | Completed

• 1 other identifier: Inno-6031
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to assess the efficacy of an antioxidant in preventing pigmentation induced by visible light in subjects with a phototype IV or V. Patients will be exposed to a range of visible light to areas on the back to confirm study eligibility. Patients showing pigmentation after 7 days on the exposed areas will be eligible to continue. Eligible patients will have study product applied to part of the back and placebo on another part of the back. The placebo area will be exposed to the same range of light based as at Day -7. The area where the antioxidant is applied will have a higher range of light exposure than the area without the study product. Seven days later, the areas will be examined to determine the lowest exposure inducing pigmentation on the sides with placebo and with antioxidant. The color will also be measured between two identical exposures with placebo and with antioxidant.

Conditions

Pigmentation From Visible Light

Outcome Measures

Primary Outcomes (1)

• Lowest mean fluence inducing visible pigmentation

  Lowest mean fluence inducing visible pigmentation 7 days after visible light exposure for skin where a topical antioxidant was applied compared to skin where control was applied.

  7 days

Secondary Outcomes (3)

• Mean difference in pigmentation intensity

  7 days

• Protection factor of antioxidant preparation against visible light

  7 days

• Safety of the antioxidant preparation

  7 days

Study Arms (2)

Antioxidant (LB) + control (UB)

OTHER

Antioxidant will be weighed and applied to an area on the lower back (LB) to be exposed with visible light at a concentration of 2 mg/cm\^2. Control will also be weighed and applied to an area of the upper back (UB) to be exposed with visible light at a concentration of 2 mg/cm\^2. These will be applied according to the randomization scheme.

Drug: Vitamin E; Drug: Eucerin

Antioxidant (UB) and Control (LB)

OTHER

Antioxidant will be weighed and applied to an area on the upper back (UB) to be exposed with visible light at a concentration of 2 mg/cm\^2. Control will also be weighed and applied to an area of the lower back (LB) to be exposed with visible light at a concentration of 2 mg/cm\^2. These will be applied according to the randomization scheme.

Drug: Vitamin E; Drug: Eucerin

Interventions

Vitamin E DRUG

Also known as: Antioxidant

Antioxidant (LB) + control (UB); Antioxidant (UB) and Control (LB)

Eucerin DRUG

Control

Antioxidant (LB) + control (UB); Antioxidant (UB) and Control (LB)

Eligibility Criteria

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

You may qualify if:

• Men or women 18 years of age or older at time of consent.
• Subject, male or female, is willing to use effective contraceptive method for at least 30 days before Day -7 and at least until Day 7±1. Effective contraceptive methods are:
• Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream;
• Hormonal contraception (oral, intramuscular, implant or transdermal) which include Depo-Provera, Evra and Nuvaring;
• Intrauterine device (IUD);
• Sterilization such as tubal ligation, hysterectomy or vasectomy;
• Postmenopausal state for at least 1 year for female subject or female partner of male subject;
• Same-sex partner;
• Abstinence.
• Capable of giving informed consent and the consent must be obtained prior to any study related procedures.
• Skin phototype IV and V
• Exhibits visible light-induced pigmentation at Day 0
• Is willing to avoid exposure to UV radiation, including sunlight, phototherapy, or tanning salon, on the back for the duration of the study and 4 weeks preceding the study.

You may not qualify if:

• Current pregnancy or lactation
• Allergy to any of the products used in the study
• Use of phototherapy or tanning beds within the 30 days of the study start (Day -7)
• Use of photosensitizing medication within the 30 days or 5 half-lives (whichever is longest) from the study start (Day-7)
• Use of products other than the ones used in the study that may alter the pigmentation of the skin
• Skin condition or medical condition altering the appearance of the skin in the area to be irradiated that would interfere with pigmentation evaluation
• Medical condition or medication putting at undue risk
• Medical condition that is unstable at the time of the study or that may interfere with the study
• History of organ transplant
• Pigmentation on the back is difficult to evaluate due to excessive hair or presence of a tattoo

Sponsors & Collaborators

• Innovaderm Research Inc.: lead

Study Sites (1)

Innovaderm Research Inc

Montreal, Quebec, H2K 4L5, Canada

Location

Related Publications (15)

• 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

• Sklar LR, Almutawa F, Lim HW, Hamzavi I. Effects of ultraviolet radiation, visible light, and infrared radiation on erythema and pigmentation: a review. Photochem Photobiol Sci. 2013 Jan;12(1):54-64. doi: 10.1039/c2pp25152c.

  PMID: 23111621 BACKGROUND

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• 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

• Pandya AG, Guevara IL. Disorders of hyperpigmentation. Dermatol Clin. 2000 Jan;18(1):91-8, ix. doi: 10.1016/s0733-8635(05)70150-9.

  PMID: 10626115 BACKGROUND

• Liebel F, Kaur S, Ruvolo E, Kollias N, Southall MD. Irradiation of skin with visible light induces reactive oxygen species and matrix-degrading enzymes. J Invest Dermatol. 2012 Jul;132(7):1901-7. doi: 10.1038/jid.2011.476. Epub 2012 Feb 9.

  PMID: 22318388 BACKGROUND

• Ball Arefiev KL, Hantash BM. Advances in the treatment of melasma: a review of the recent literature. Dermatol Surg. 2012 Jul;38(7 Pt 1):971-84. doi: 10.1111/j.1524-4725.2012.02435.x. Epub 2012 May 14.

  PMID: 22583339 BACKGROUND

• Chen L, Hu JY, Wang SQ. The role of antioxidants in photoprotection: a critical review. J Am Acad Dermatol. 2012 Nov;67(5):1013-24. doi: 10.1016/j.jaad.2012.02.009. Epub 2012 Mar 9.

  PMID: 22406231 BACKGROUND

• Sheth VM, Pandya AG. Melasma: a comprehensive update: part I. J Am Acad Dermatol. 2011 Oct;65(4):689-697. doi: 10.1016/j.jaad.2010.12.046.

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• Kameyama K, Sakai C, Kondoh S, Yonemoto K, Nishiyama S, Tagawa M, Murata T, Ohnuma T, Quigley J, Dorsky A, Bucks D, Blanock K. Inhibitory effect of magnesium L-ascorbyl-2-phosphate (VC-PMG) on melanogenesis in vitro and in vivo. J Am Acad Dermatol. 1996 Jan;34(1):29-33. doi: 10.1016/s0190-9622(96)90830-0.

  PMID: 8543691 BACKGROUND

• Ertam I, Mutlu B, Unal I, Alper S, Kivcak B, Ozer O. Efficiency of ellagic acid and arbutin in melasma: a randomized, prospective, open-label study. J Dermatol. 2008 Sep;35(9):570-4. doi: 10.1111/j.1346-8138.2008.00522.x.

  PMID: 18837701 BACKGROUND

• Hwang SW, Oh DJ, Lee D, Kim JW, Park SW. Clinical efficacy of 25% L-ascorbic acid (C'ensil) in the treatment of melasma. J Cutan Med Surg. 2009 Mar-Apr;13(2):74-81. doi: 10.2310/7750.2008.07092.

  PMID: 19298775 BACKGROUND

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  PMID: 3519762 BACKGROUND

• Wu Y, Matsui MS, Chen JZ, Jin X, Shu CM, Jin GY, Dong GH, Wang YK, Gao XH, Chen HD, Li YH. Antioxidants add protection to a broad-spectrum sunscreen. Clin Exp Dermatol. 2011 Mar;36(2):178-87. doi: 10.1111/j.1365-2230.2010.03916.x. Epub 2010 Aug 27.

  PMID: 20804506 BACKGROUND

MeSH Terms

Interventions

Vitamin E; Antioxidants; eucerin

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Study Officials

• Robert Bissonnette, MD, FRCPC

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 22, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 4, 2014

Record last verified: 2014-03

Locations

CA (1)