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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-28

Study Completion Date

2023-11-06

Brief Summary

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

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Detailed Description

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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

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Gene Expression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, single-center, comparative study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Poly L-Lactic Acid (PLLA)

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

Group Type ACTIVE_COMPARATOR

Sculptra

Intervention Type DEVICE

Biostimulator

Calcium Hydroxylapatite (CaHA)

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.

Group Type ACTIVE_COMPARATOR

Radiesse Plus

Intervention Type DEVICE

Semi-permanent filler

Interventions

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Sculptra

Biostimulator

Intervention Type DEVICE

Radiesse Plus

Semi-permanent filler

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes