Status:
COMPLETED
Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of Aging
Lead Sponsor:
Cosmetique Active International
Collaborating Sponsors:
Innovaderm Research Inc.
Conditions:
Skin Aging
Eligibility:
FEMALE
45-55 years
Phase:
NA
Brief Summary
Facial skin aging is a complex process combining factors such as sun exposure, smoking and those that are believed to be inherited. Changes in the skin over time including decreased thickness result i...
Detailed Description
Facial skin aging is a complex and multifactorial process combining extrinsic and intrinsic factors. Major extrinsic factors include sun exposure and smoking while intrinsic factors are believed to be...
Eligibility Criteria
Inclusion
- Subjects are female, between 45 and 55 years of age.
- Females of childbearing potential have had a negative urine pregnancy test prior to randomization.
- Subjects are willing to use adequate contraceptive method or are surgically sterile (including tubal ligation), post-menopausal, abstinent or with a same-sex partner. Adequate means of contraception include; intra-uterine device (IUD) in use for 30 days before Day 0, barrier methods and spermicide in use at least 14 days before Day 0 or oral contraceptive in use for at least 30 days before Day 0.
- Subjects are willing to avoid prolonged exposure to UV radiation for the duration of the study.
- Subjects are capable of giving written informed consent.
- Subjects have changes associated with facial skin aging/photodamaged skin.
Exclusion
- Subjects are male.
- Subjects are pregnant or lactating.
- Subjects have a known allergy to Redermic, Rejuva-A™ or to any component of the tested products.
- Subjects have made use of tretinoin, adapalene, tazarotene or other topical medications for the treatment of facial skin aging during the 12 weeks preceding Day 0.
- Subjects have applied topical alpha hydroxyl acids within 28 days of Day 0.
- Subjects have used or plan to use systemic corticosteroids within 28 days of Day 0 or during the study.
- Subjects have made use of a non-medication topical product directed at improving skin aging during the 28 days preceding Day 0.
- Subjects have a hypersensitivity to any retinoids.
- Subjects have a history of alcohol or drug abuse in the past year.
- Subjects are participating in another interventional study.
- Subjects have had a previous intense pulsed light treatment to the face.
- Subjects have had a previous laser treatment to the face directed at improving skin aging.
- Subjects have the presence of skin diseases such as psoriasis or dermatitis on the face that could interfere with study evaluations.
- Planned or unavoidable exposure to intense ultraviolet (UV) radiation during the study (such as sun tanning salons, vacations in a sunny climate or outdoor worker).
- Subjects have had a botulinum toxin A injection treatment on the face within 2 years of Day 0 or plan to receive this treatment during the study.
- Subjects have had a filler injection (collagen, hyaluronic acid, etc..) on the face within 2 years of Day 0 or plan to receive this treatment during the study.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00974480
Start Date
September 1 2009
End Date
July 1 2010
Last Update
September 20 2011
Active Locations (1)
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1
Innovaderm Research Inc
Montreal, Quebec, Canada, H2K 4L5