Gene Expression
Conditions
Brief summary
To compare gene expression stimulated by a semi-permanent filler and a biostimulator via punch biopsy
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.
Interventions
DEVICESculptra
Biostimulator
DEVICERadiesse Plus
Semi-permanent filler
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized, single-center, comparative study
Eligibility
Sex/Gender
ALL
Age
22 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gene Expression | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJill S Waibel, MD
Miami Dermatology & Laser Institute
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 3.8 |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian Non-Hispanic | 7 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 14 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
None listed