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

No Placebo-Only Group

Summary

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Analyze gene expression via punch biopsy

Secondary study objectives

Evaluate volume change in the treated area using 3D imaging

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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