The Emotional and Functional Benefits of Poly-L-Lactic Acid

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluates the emotional and functional benefits of Poly-L-Lactic Acid (Sculptra™), a cosmetic product used to fill defects of the skin. All participants will receive Sculptra™.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yardley Dermatology Associates
• Collaborator: Galderma Laboratories, L.P.

Criteria

Inclusion Criteria:

1. Subject must be an outpatient, male or female subjects of any race, 35 years of age or older.

2. Subject must have any degree of facial volume loss.

3. Subjects of all Fitzpatrick skin types are eligible.

4. Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.

5. Subject must sign an IRB-approved Informed Consent form, Photographic Release Form, and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed.

Exclusion Criteria:

1. Any of the previous facial treatments:

c. Any facial filler in the past 2 years d. Prior injection of permanent facial implant

2. Have any skin pathology or condition that could interfere with the evaluation of the face.

3. Be unable to communicate or cooperate with the Investigator due to a language barrier (non-English speaking), poor mental development, or impaired cerebral function.

4. Have evidence of alcohol or drug abuse (Investigator opinion), or history of poor cooperation, non-compliance with medical treatment, or unreliability.

5. Have used an investigational device, biologic or drug in the past 30 days, or be currently participating in an experimental drug, biologic or device trial.

6. Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

7. Be an employee (or a relative of an employee) of the Investigator, Sponsor or representative of the Sponsor.