Status:
COMPLETED
Biopsy Study for Sculptra (Poly-L-Lactic Acid)
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
35-55 years
Phase:
NA
Brief Summary
The primary objective of this study involves research to evaluate new collagen (the elastic fibers that provide skin with its strength and resilience) formation in the skin following injections of Scu...
Eligibility Criteria
Inclusion
- If female, the subject must use appropriate form of birth control.
Exclusion
- History of allergies or an allergic reaction to local numbing medications (e.g., lidocaine, etc.), latex, or silicone.
- History of forming large scars following an accident or surgery.
- History of any bleeding problems.
- Redness, swelling, or signs of infection behind the right or left ear between the area of the earlobe and hairline.
- Pimples, rashes, scarring or any other skin changes behind the right or left ear between the area of the earlobe and hairline.
- History of any medical problems (for example, heart attack, stroke, diabetes/high blood sugar, hepatitis, human immunodeficiency virus (HIV), severe asthma, rheumatoid arthritis, emphysema, breathing problems). Subjects with high blood pressure or high cholesterol may qualify for the study if there have been no changes in their medications for three (3) months.
- History of cancer within five (5) years.
- Previous cosmetic surgery or cosmetic procedures affecting the area behind the ear.
- Subject who plans to have any facial or ear surgery within the next year.
- History of alcohol or drug abuse.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00869687
Start Date
March 1 2009
End Date
May 1 2010
Last Update
November 20 2019
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Laval, Canada