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

Bausch Health

Status: Completed

Conditions: Healthy Volunteers

Treatments: Device: Poly-L-Lactic Acid Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00869687

POLYL_L_02888

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 35 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Poly-L-Lactic Acid Injection

Other group

Treatment:

Device: Poly-L-Lactic Acid Injection