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

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

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

Study Overview

• Status: Completed
• Conditions: Gene Expression
• Intervention / Treatment: Device: Sculptra; Device: Radiesse Plus

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33173
      • Miami Dermatology & Laser Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene Expression	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

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Jill S Waibel, MD, Miami Dermatology & Laser Institute

Publications and helpful links

General Publications

• Waibel J, Ziegler M, Nguyen TQ, Le JHTD, Qureshi A, Widgerow A, Meckfessel M. Comparative Bulk RNA-Seq Analysis of Poly-l-Lactic Acid Versus Calcium Hydroxylapatite Reveals a Novel, Adipocyte-Mediated Regenerative Mechanism of Action Unique to PLLA. Dermatol Surg. 2024 Nov 1;50(11S):S166-S171. doi: 10.1097/DSS.0000000000004425.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): November 6, 2023

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GLI.04.US.SL.020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No