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

NCT02613481 | Completed Results

• 1 other identifier: YDA-001
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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™.

Conditions

Facial Volume Loss

Outcome Measures

Primary Outcomes (4)

• Mean Subject Self Reported Quality of Life Scale

  Self report Likert Scale Title: Facial Volume Restoration Outcome Questionnaire 35 Questions 1-7 rating with higher score meaning a worse outcome

  3 months post initial injection

• Mean Rosenberg Self-Esteem Scale

  Self reported self esteem measure Title: Rosenberg Self-Esteem Scale Scale of 1-4, scale design with higher score relating to worse outcome.

  3 months post initial injection

• Mean Rosenberg Self-Esteem Scale

  Self reported self esteem measure Title: Rosenberg Self-Esteem Scale Scale of 1-4, scale design with higher score relating to worse outcome.

  6 months post initial injection

• Mean Subject Self Reported Quality of Life Scale

  Self report Likert Scale Title: Facial Volume Restoration Outcome Questionnaire 35 Questions 1-7 rating with higher score meaning a worse outcome

  6 months post initial injection

Study Arms (1)

Poly-L-Lactic Acid (Sculptra) injection

OTHER

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

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

Interventions

Poly-L-Lactic Acid (Sculptra) injection DRUG

1 vial of of poly-l-lactic acid (Sculptra) reconstituted in the usual sterile fashion with 7cc of sterile water and 2cc of Lidocaine without epinephrine. The contents of the vial will be injected as deemed appropriate by the certified injector and agreed upon by the study subject.

Poly-L-Lactic Acid (Sculptra) injection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be an outpatient, male or female subjects of any race, 35 years of age or older.
• Subject must have any degree of facial volume loss.
• Subjects of all Fitzpatrick skin types are eligible.
• Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.
• 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.

You may not qualify if:

• Any of the previous facial treatments:
• c. Any facial filler in the past 2 years d. Prior injection of permanent facial implant
• Have any skin pathology or condition that could interfere with the evaluation of the face.
• Be unable to communicate or cooperate with the Investigator due to a language barrier (non-English speaking), poor mental development, or impaired cerebral function.
• Have evidence of alcohol or drug abuse (Investigator opinion), or history of poor cooperation, non-compliance with medical treatment, or unreliability.
• 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.
• 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.
• Be an employee (or a relative of an employee) of the Investigator, Sponsor or representative of the Sponsor.

Sponsors & Collaborators

• Yardley Dermatology Associates: lead
• Galderma R&D: collaborator

Related Links

• Click here for more information about this study: The Emotional and Functional Benefits of Poly-L-Lactic Acid

MeSH Terms

Interventions

poly(lactide); New-Fill; Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Yardley Dermatology Associates, PC

rfried@yardleyderm.com

2155796155

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 24, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 29, 2019
• Results First Posted: May 29, 2019

Record last verified: 2019-05