Poly L-Lactic Acid (PLLA) for Gene Expression (Sculptra Trial)

N/A

Waitlist Available

Led By Jill S Waibel, MD

Research Sponsored by Galderma R&D

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 and 12 weeks after baseline

Awards & highlights

Sculptra Trial Summary

This trial compared how two treatments (filler & biostimulator) affect gene expression in skin samples.

Sculptra Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Analyze gene expression via punch biopsy

Secondary outcome measures

Evaluate volume change in the treated area using 3D imaging

Sculptra Trial Design

2Treatment groups

Active Control

Group I: Poly L-Lactic Acid (PLLA)Active Control1 Intervention

Lyophilized PLLA with sodium carboxymethylcellulose, non-pyrogenic mannitol. Treatment needs to be reconstituted prior to injection, following product instruction.

Group II: Calcium Hydroxylapatite (CaHA)Active Control1 Intervention

Opaque, sterile, non-pyrogenic, semi-solid, cohesive implant whose component is synthetic CaHA suspended in a gel carrier of glycerin, sodium carboxymethylcellulose, 0.3% lidocaine hydrochloride, and sterile water. Treatment injection follows product instruction.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor

297 Previous Clinical Trials

60,240 Total Patients Enrolled

Jill S Waibel, MDPrincipal InvestigatorMiami Dermatology & Laser Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment still seeking participants?

"As per the details found on clinicaltrials.gov, this medical trial has stopped enrolling patients. The study was initially published on September 28th 2022 and updated two weeks ago but is no longer recruiting participants. Nonetheless, 3 other studies are currently looking for volunteers to take part in their research."

Answered by AI

Am I able to register for this research experiment?

"The trial is enrolling 20 individuals aged between 22 and 50 with gene expression, who have shallow nasolabial fold contours as evaluated by the Wrinkle Assessment Scale. Furthermore, they must be capable of giving consent to partake in this study and willing to undergo skin biopsies on their NLFs."

Answered by AI