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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Poly-L-Lactic Acid Injection

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Laval, Canada
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Poly-L-Lactic Acid Injection	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Biopsies change from baseline to 6 months after first Sculptra injection in level of Type 1 collagen.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: Tara Semanchik, MBA, Sanofi

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ACTUAL): May 1, 2010
• Study Completion (ACTUAL): May 1, 2010

Study Registration Dates

• First Submitted: March 25, 2009
• First Submitted That Met QC Criteria: March 25, 2009
• First Posted (ESTIMATE): March 26, 2009

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: POLYL_L_02888