Sculptra: Gene Expression Study Between Two Dermal Injectables Hydroxylapatite Semi-permanent Filler
Study Details
Study Description
Brief Summary
To compare gene expression stimulated by a semi-permanent filler and a biostimulator via punch biopsy
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Analyze gene expression via punch biopsy [12 weeks after baseline]
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.
Secondary Outcome Measures
- Evaluate volume change in the treated area using 3D imaging [4 and 12 weeks after baseline]
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.
Eligibility Criteria
Criteria
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
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History of allergy or hypersensitivity to any ingredient of the treatment products
-
History of allergy or hypersensitivity to anesthetics or lidocaine
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Miami Dermatology & Laser Institute | Miami | Florida | United States | 33173 |
Sponsors and Collaborators
- Galderma R&D
Investigators
- Principal Investigator: Jill S Waibel, MD, Miami Dermatology & Laser Institute
Study Documents (Full-Text)
More Information
Publications
None provided.- GLI.04.US.SL.020