Biopsy Study for Sculptra (Poly-L-Lactic Acid)
This study has been completed.
Information provided by (Responsible Party):
First received: March 25, 2009
Last updated: June 22, 2012
Last verified: June 2012
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 Sculptra (Poly-L-Lactic Acid or PLLA). The secondary objectives of the study are to better understand the human skin responses to Sculptra and to assess the safety of Sculptra injections.
Device: Poly-L-Lactic Acid Injection
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
||A Single Group Study for the Characterization of Human Tissue Response to Injectable Poly-L-Lactic Acid (Sculptra) in Healthy Volunteers
Primary Outcome Measures:
- Biopsies change from baseline to 6 months after first Sculptra injection in level of Type 1 collagen. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in level of Type 1 collagen at 3 months and 12 months [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
- Change from baseline in level of Type III collagen at 3 months, 6 months, & 12 months by immunohistochemistry in a central laboratory. [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
- Qualitative assessment in degree of change from baseline in Type I collagen at 3 months, 6 months, & 12 months by a pathologist. [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
- Degree of inflammation assessed by histology at 3 months, 6 months, and 12 months. [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
- Qualitative assessment in degree of change from baseline in Type III collagen at 3 months, 6 months, & 12 months by a pathologist. [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2010 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||35 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- If female, the subject must use appropriate form of birth control.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869687
|Sanofi-Aventis Administrative Office
|Laval, Canada |
||Tara Semanchik, MBA
No publications provided
ClinicalTrials.gov processed this record on March 05, 2014
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 25, 2009
||June 22, 2012
||Canada: Health Canada