The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
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, Learn About Clinical Studies.
Ages Eligible for Study:
35 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
If female, the subject must use appropriate form of birth control.
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.