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

Galderma

Status: Completed

Conditions: Gene Expression

Treatments: Device: Sculptra; Device: Radiesse Plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT05620043

GLI.04.US.SL.020

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 22 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject with a minimum of shallow nasolabial fold (NLF) contour deficiencies as assessed via the wrinkle assessment scale
• Subject with identical WAS scores on both NLFs
• Ability of giving consent for participation in the study
• Agreement to have skin biopsies on NLFs

Exclusion criteria

• Significant NLF asymmetry, or different WAS score on each NLF
• Pregnant, planning pregnancy during the course of the study or breastfeeding
• History of allergy or hypersensitivity to any ingredient of the treatment products
• History of allergy or hypersensitivity to anesthetics or lidocaine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

Poly L-Lactic Acid (PLLA)

Active Comparator group

Description:

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

Treatment:

Device: Sculptra

Calcium Hydroxylapatite (CaHA)

Active Comparator group

Description:

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.

Treatment:

Device: Radiesse Plus