Vitamin E Prevention of Visible Light Pigmentation

March 3, 2014 updated by: Innovaderm Research Inc.

Effect of Vitamin E in the Prevention of Visible Light Induced Pigmentation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At Day -7, all subjects will be exposed to a pre-specified range of doses of visible light on 6 areas of the back, each measuring 0.9 cm^2 in order to evaluate their pigmentary response to visible light. The doses will be 20, 40, 80, 160, 320 and 640 J/cm^2. At Day 0, a visual inspection will establish which subjects qualify for the remainder of the study, based on the presence or absence of pigmentation induced by visible light. Subjects who do not exhibit pigmentation at 640 J/cm^2 or lower will not pursue the study.

Subjects who demonstrate pigmentation will move on to the next step of the study. On this same Day 0 visit, these subjects will be randomized to receive a topical antioxidant preparation on one of two halves of their back and a control on the other side. The antioxidant and control will be applied twice before the exposure to visible light is done on Day 1: 24 hours prior (Day 0) and 30 minutes prior (Day 1) exposure. On Day 1, the skin with antioxidant will be exposed to fluences of 80, 160, 320, 640, 1280 and 1920 J/cm^2 whereas that with control will be exposed to the same lower doses as on Day -7. This will be done on a total of 12 different areas of 0.9 cm^2 each, with six on the side with antioxidant preparation, and six on the side with control.

On Day 7±1, a visual assessment will be done of each exposed area, as well as quantitative colorimetric measurements and a research photograph. The visual assessment will consist in determination of the lowest fluence inducing visible pigmentation on each half back (with antioxidant and with control). The colorimetric measurements will be done on areas exposed to 320 and 640 J/cm^2 to compare the pigmentation present on skin to which antioxidant was applied and on skin to which control was applied. The colorimetric assessment of adjacent unexposed skin will also be performed. At Day 0, 1 and 7 visits, subjects will also be evaluated for adverse events.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2K 4L5
        • Innovaderm Research Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men or women 18 years of age or older at time of consent.

  2. 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:

    1. Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream;
    2. Hormonal contraception (oral, intramuscular, implant or transdermal) which include Depo-Provera, Evra and Nuvaring;
    3. Intrauterine device (IUD);
    4. Sterilization such as tubal ligation, hysterectomy or vasectomy;
    5. Postmenopausal state for at least 1 year for female subject or female partner of male subject;
    6. Same-sex partner;
    7. Abstinence.
  3. Capable of giving informed consent and the consent must be obtained prior to any study related procedures.
  4. Skin phototype IV and V
  5. Exhibits visible light-induced pigmentation at Day 0
  6. 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Antioxidant (LB) + control (UB)
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
Other Names:
  • Antioxidant
Drug: Eucerin
Control
Other: Antioxidant (UB) and Control (LB)
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
Other Names:
  • Antioxidant
Drug: Eucerin
Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lowest mean fluence inducing visible pigmentation
Time Frame: 7 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference in pigmentation intensity
Time Frame: 7 days
Difference in pigmentation intensity between skin with antioxidant and skin with control.
7 days
Protection factor of antioxidant preparation against visible light
Time Frame: 7 days
Protection factor of antioxidant preparation against visible light between antioxidant and control.
7 days
Safety of the antioxidant preparation
Time Frame: 7 days
Safety of the antioxidant preparation measured by the number of adverse events and the severity of adverse events compared to control
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovaderm Research Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

August 20, 2013

First Submitted That Met QC Criteria

August 21, 2013

First Posted (Estimate)

August 22, 2013

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

March 3, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Inno-6031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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