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

NCT05620043 | Completed Results FDA Device

• 1 other identifier: GLI.04.US.SL.020
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gene Expression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Poly L-Lactic Acid (PLLA)

ACTIVE COMPARATOR

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

Device: Sculptra

Calcium Hydroxylapatite (CaHA)

ACTIVE COMPARATOR

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

Interventions

Sculptra DEVICE

Biostimulator

Poly L-Lactic Acid (PLLA)

Radiesse Plus DEVICE

Semi-permanent filler

Calcium Hydroxylapatite (CaHA)

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Miami Dermatology & Laser Institute

Miami, Florida, 33173, United States

Location

Related Publications (1)

• 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.

  PMID: 39480040 DERIVED

Results Point of Contact

• Title: Thu Q. Nguyen, PhD
• Organization: Galderma

thu.nguyen@galderma.com

8179615495

Study Officials

• Jill S Waibel, MD

  Miami Dermatology & Laser Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, single-center, comparative study

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 17, 2022
• Study Start: September 28, 2022
• Primary Completion: July 25, 2023
• Study Completion: November 6, 2023
• Last Updated: April 15, 2026
• Results First Posted: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)