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

NCT00869687 | Completed

• 1 other identifier: POLYL_L_02888
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Biopsies change from baseline to 6 months after first Sculptra injection in level of Type 1 collagen.

  6 months

Secondary Outcomes (5)

• Change from baseline in level of Type 1 collagen at 3 months and 12 months

  3 and 12 months

• Change from baseline in level of Type III collagen at 3 months, 6 months, & 12 months by immunohistochemistry in a central laboratory.

  3, 6, and 12 months

• Qualitative assessment in degree of change from baseline in Type I collagen at 3 months, 6 months, & 12 months by a pathologist.

  3, 6, and 12 months

• Degree of inflammation assessed by histology at 3 months, 6 months, and 12 months.

  3, 6, and 12 months

• Qualitative assessment in degree of change from baseline in Type III collagen at 3 months, 6 months, & 12 months by a pathologist.

  3, 6, and 12 months

Study Arms (1)

Poly-L-Lactic Acid Injection

OTHER

Device: Poly-L-Lactic Acid Injection

Interventions

Poly-L-Lactic Acid Injection DEVICE

0.05 mL of poly-l-lactic acid will be injected as depot at three (3) points (a total of 0.15 mL).

Poly-L-Lactic Acid Injection

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Laval, Canada

Location

Study Officials

• Tara Semanchik, MBA

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 26, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

CA (1)