Clinical trial NCT02613481: The Emotional and Functional Benefits of Poly-L-Lactic Acid
Official title: The Emotional and Functional Benefits of Poly-L-Lactic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Volume Loss
Lead sponsor: Yardley Dermatology Associates
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2015-11-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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™.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Mean Subject Self Reported Quality of Life Scale
timeFrame: 3 months post initial injection
measure: Mean Rosenberg Self-Esteem Scale
timeFrame: 3 months post initial injection
measure: Mean Rosenberg Self-Esteem Scale
timeFrame: 6 months post initial injection
measure: Mean Subject Self Reported Quality of Life Scale
timeFrame: 6 months post initial injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: