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

N/ACompletedNCT05620043

Galderma R&D21 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gene Expression

Interventions

SculptraDEVICE

Biostimulator

Radiesse PlusDEVICE

Semi-permanent filler

Eligibility

Sex: ALLMin age: 22 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Miami Dermatology & Laser Institute

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks after baseline

Secondary Outcomes

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.

Time frame: 4 and 12 weeks after baseline

Data from ClinicalTrials.gov

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