CompletedNot Applicable

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

50 participantsStarted 2015-11

Plain-language 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™.

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. Any of the previous facial treatments:
✕. 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.

What they're measuring

Mean Subject Self Reported Quality of Life Scale

Timeframe: 3 months post initial injection

Mean Rosenberg Self-Esteem Scale

Timeframe: 3 months post initial injection

Mean Rosenberg Self-Esteem Scale

Timeframe: 6 months post initial injection

Mean Subject Self Reported Quality of Life Scale

Timeframe: 6 months post initial injection

Trial details

NCT IDNCT02613481

SponsorYardley Dermatology Associates

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06-01

Results submitted2019-01-09

View on ClinicalTrials.gov More Facial Volume Loss trials

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. Any of the previous facial treatments:
✕. 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.

What they're measuring

Mean Subject Self Reported Quality of Life Scale

Timeframe: 3 months post initial injection

Mean Rosenberg Self-Esteem Scale

Timeframe: 3 months post initial injection

Mean Rosenberg Self-Esteem Scale

Timeframe: 6 months post initial injection

Mean Subject Self Reported Quality of Life Scale

Timeframe: 6 months post initial injection