Avene Compact Honey for Prevention of Pigmentation From Visible Light

NCT01448122 | Completed

• 1 other identifier: RV 4140 A 2011 176
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to assess the efficacy of Avène Compact Honey in preventing pigmentation induced by visible light in subjects with a phototype III or IV. 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. The back will be exposed to a range of light based on the minimum exposure inducing pigmentation previously ascertained. The area where study product 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 and without study product. The color will also be measured between two identical exposures with and without the applied study product.

Conditions

Healthy

Keywords

Prevention of pigmentation

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 protected with Avène Compact Honey as compared to unprotected skin.

  7 days

Secondary Outcomes (2)

• Mean difference in pigmentation darkness

  7 Days

• Adverse Events

  7 Days

Study Arms (2)

Avene Compact Honey SPF 50

ACTIVE COMPARATOR

Study product will be scraped from compact case and weighed. Product will be applied to half the area to be exposed with visible light at a concentration of 2 mg/mL.

Other: Avene Compact Honey SPF 50

No intervention

NO INTERVENTION

Half of the area to be exposed to visible light will have no study product applied.

Interventions

Avene Compact Honey SPF 50 OTHER

Patients will have part of their back covered with 2 mg/mL of Avene Compact Honey SPF 50.

Also known as: Avene Compact Doré SPF 50

Avene Compact Honey SPF 50

Eligibility Criteria

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

You may qualify if:

• Subject is male or female, 18 years of age or older at time of consent.
• Subject has a skin phototype of III or IV.
• Subject (or subject's partner), male or female, is willing to use effective contraceptive method for at least 30 days before Day -7 and until Day 7. 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.
• Subject must be willing to avoid exposure to UV radiation (tanning beds, phototherapy, and sunlight) on the back for the duration of the study.
• Subject is capable of giving informed consent and the consent must be obtained prior to any study related procedures.
• Subject has sufficient pigmentation at Day 0 in at least one area after exposure to varying doses of visible light at Day -7.

You may not qualify if:

• Subject is currently pregnant or lactating.
• Subject has a known allergy to the study product or a component of the study product.
• Subject has used photosensitizing medication (in UV and in the visible range) within 30 days of the Day -7 visit up to the Day 7 visit.
• Subject has a history of photodermatosis.
• Subject has the presence of a skin disorder in the area to be irradiated that would either put the subject at increased risk or interfere with pigmentation evaluation.
• Subject has a medical condition or is taking medication that could put him or her at undue risk.
• Subject has a cardiovascular, pulmonary, digestive, neurological, urinary, psychiatric, hematological, immunological, or endocrinal pathology that is unstable or able to interfere with the study.
• Subject has undergone organ removal or organ transplant
• Subject is currently receiving treatment that may interfere with interpretation of the study results.
• Subject for whom, in the Investigator's opinion, pigmentation on the back will be difficult to evaluate (such as subjects with excessive hair or a tattoo).

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Innovaderm Research Inc

Montreal, Quebec, H2K 4L5, Canada

Location

Study Officials

• Robert Bissonnette, MD, FRCPC

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Robert Bissonnette MD, FRCPC

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: October 7, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 27, 2013

Record last verified: 2013-02

Locations

CA (1)