NCT05620043

Gene Expression Study Between Two Dermal Injectables Hydroxylapatite Semi-permanent Filler

A Randomized, Single-center, Prospective Biopsy Study Comparing a Poly L-lactic Acid Biostimulator and a Calcium Hydroxylapatite Semi-permanent Filler

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 22 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To compare gene expression stimulated by a semi-permanent filler and a biostimulator via punch biopsy

Detailed description

This is a randomized, single-center, comparative study to evaluate gene expression after treatment with a semi-permanent filler or a biostimulator. This study is designed to enroll and randomize approximately 20 subjects in a 1:1 ratio of treatment to PLLA or CaHA. All randomized subjects are to have contour deficiency at the nasolabial folds. Eligible subjects randomized to receive punch biopsy followed by treatment injection by the Treating Investigator at baseline. The method of injection was at the discretion of the Treating Investigator. A sufficient amount of product is injected to achieve optimal correction of the nasolabial folds, in the opinion of the Treating Investigator. PLLA group receives a second treatment at week 4 while CaHA group receives an optional touch-up if needed. All subjects have final follow-up visit for a second punch biopsy on the other side of the nasolabial fold.

Conditions

• Gene Expression

Interventions

Type	Name	Description
DEVICE	Sculptra	Biostimulator
DEVICE	Radiesse Plus	Semi-permanent filler

Timeline

• Start date: 2022-09-28
• Primary completion: 2023-07-25
• Completion: 2023-11-06
• First posted: 2022-11-17
• Last updated: 2026-04-15
• Results posted: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study