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

Yardley Dermatology Associates

Status: Completed

Conditions: Facial Volume Loss

Treatments: Drug: Poly-L-Lactic Acid (Sculptra) injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02613481

YDA-001

Details and patient eligibility

About

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™.

Full description

Facial volume loss can result in emotional distress and functional impairment in some affected individuals. Poly-L-Lactic Acid (Sculptra™) stimulates collagen production in the skin thereby replenishing some of the collagen lost to natural aging and ultraviolet damage. This study will assess the emotional and functional benefits of Poly-L-Lactic Acid treated subject's through self report measurement tools.

Enrollment: 50 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Poly-L-Lactic Acid (Sculptra) injection

Other group

Description:

Poly-L-Lactic Acid (Sculptra) injection for all enrolled subjects

Treatment:

Drug: Poly-L-Lactic Acid (Sculptra) injection