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Biopsy Study for Sculptra (Poly-L-Lactic Acid)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00869687
First received: March 25, 2009
Last updated: June 22, 2012
Last verified: June 2012

March 25, 2009
June 22, 2012
March 2009
May 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00869687 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Biopsy Study for Sculptra (Poly-L-Lactic Acid)
A Single Group Study for the Characterization of Human Tissue Response to Injectable Poly-L-Lactic Acid (Sculptra) in Healthy Volunteers

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy Volunteers
Device: Poly-L-Lactic Acid Injection
0.05 mL of poly-l-lactic acid will be injected as depot at three (3) points (a total of 0.15 mL).
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • If female, the subject must use appropriate form of birth control.

Exclusion Criteria:

  • 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.

Both
35 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00869687
POLYL_L_02888
No
Sanofi
Sanofi
Not Provided
Study Director: Tara Semanchik, MBA Sanofi
Sanofi
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP