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
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Device: Poly-L-Lactic Acid Injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Single Group Study for the Characterization of Human Tissue Response to Injectable Poly-L-Lactic Acid (Sculptra) in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Sanofi:

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 ]

Enrollment: 14
Study Start Date: March 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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).
  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869687

Locations
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Tara Semanchik, MBA Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00869687     History of Changes
Other Study ID Numbers: POLYL_L_02888
Study First Received: March 25, 2009
Last Updated: June 22, 2012
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on October 22, 2014