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

NCT ID: NCT00869687

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Poly-L-Lactic Acid Injection

Group Type: OTHER

Poly-L-Lactic Acid Injection

Intervention Type: DEVICE

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

Interventions

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).

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tara Semanchik, MBA

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Laval, , Canada

Countries

Canada

Other Identifiers

POLYL_L_02888

Identifier Type: -

Identifier Source: org_study_id