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

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

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.

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

Conditions
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Gene Expression

Intervention / Treatment
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* Device: Sculptra
* Device: Radiesse Plus


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, single-center, comparative study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Poly L-Lactic Acid (PLLA)<br>Lyophilized PLLA with sodium carboxymethylcellulose, non-pyrogenic mannitol. Treatment needs to be reconstituted prior to injection, following product instruction. | Device: Sculptra<br>* Biostimulator<br>|
| Active Comparator: Calcium Hydroxylapatite (CaHA)<br>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. | Device: Radiesse Plus<br>* Semi-permanent filler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze gene expression via punch biopsy | Summary of fold change using by relative quantification method at week 12. Gene expression analysis is performed via qPCR processing using a panel of biomarkers related to scar tissue formation, collagen, elastin, extracellular matrix integrity, epidermal barrier, anti-aging, antioxidant, cell renewal/regeneration, inflammation, growth factor, and hydration among others. | 12 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate volume change in the treated area using 3D imaging | Summary of total volume change in the nasolabial fold area measured by 3D photography at each visit. Total volume change corresponds to net volume change from baseline in the nasolabial fold. | 4 and 12 weeks after baseline |