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

Gene Expression Clinical Trial

— Sculptra  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05620043
• Other study ID #: GLI.04.US.SL.020
• Status: Completed
• Phase: N/A
• Start date: September 28, 2022
• Est. completion date: November 6, 2023

Study information

• Verified date: October 2022
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 6, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Gene Expression

Intervention

Device:
• Sculptra
Biostimulator
• Radiesse Plus
Semi-permanent filler

Locations

Country	Name	City	State
United States	Miami Dermatology & Laser Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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