Status:
COMPLETED
Avene Compact Honey for Prevention of Pigmentation From Visible Light
Lead Sponsor:
Pierre Fabre Dermo Cosmetique
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
Detailed Description
Part A At Day -7, all subjects will be exposed to a range of doses of visible light on an approximately 0.90 cm diameter area on the back to ascertain their predisposition for pigmentation induced by ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01448122
Start Date
October 1 2011
End Date
December 1 2012
Last Update
February 27 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Innovaderm Research Inc
Montreal, Quebec, Canada, H2K 4L5