Trial Outcomes & Findings for Gene Expression Study Between Two Dermal Injectables Hydroxylapatite Semi-permanent Filler (NCT NCT05620043)
NCT ID: NCT05620043
Last Updated: 2026-04-15
Results Overview
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.
COMPLETED
NA
21 participants
12 weeks after baseline
2026-04-15
Participant Flow
Participant milestones
| Measure |
Poly L-Lactic Acid (PLLA)
Lyophilized PLLA with sodium carboxymethylcellulose, non-pyrogenic mannitol. Treatment needs to be reconstituted prior to injection, following product instruction.
Sculptra: Biostimulator
|
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.
Radiesse Plus: Semi-permanent filler
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gene Expression Study Between Two Dermal Injectables Hydroxylapatite Semi-permanent Filler
Baseline characteristics by cohort
| Measure |
Poly L-Lactic Acid (PLLA)
n=11 Participants
Lyophilized PLLA with sodium carboxymethylcellulose, non-pyrogenic mannitol. Treatment needs to be reconstituted prior to injection, following product instruction.
Sculptra: Biostimulator
|
Calcium Hydroxylapatite (CaHA)
n=10 Participants
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.
Radiesse Plus: Semi-permanent filler
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 4.7 • n=193 Participants
|
46.4 years
STANDARD_DEVIATION 2.5 • n=193 Participants
|
46 years
STANDARD_DEVIATION 3.8 • n=386 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=193 Participants
|
7 Participants
n=193 Participants
|
17 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian Non-Hispanic
|
4 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
7 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
7 Participants
n=193 Participants
|
7 Participants
n=193 Participants
|
14 Participants
n=386 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=193 Participants
|
10 participants
n=193 Participants
|
21 participants
n=386 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after baselinePopulation: 107 target genes that play important roles in skin biology and 10 genes in wound healing
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.
Outcome measures
| Measure |
Poly L-Lactic Acid (PLLA)
n=117 Gene number
Lyophilized PLLA with sodium carboxymethylcellulose, non-pyrogenic mannitol. Treatment needs to be reconstituted prior to injection, following product instruction.
Sculptra: Biostimulator
|
Calcium Hydroxylapatite (CaHA)
n=117 Gene number
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.
Radiesse Plus: Semi-permanent filler
|
|---|---|---|
|
Gene Expression
Upregulated genes in inflammatory/immune response
|
1 Significantly upregulated genes
|
4 Significantly upregulated genes
|
|
Gene Expression
Upregulated genes in wound healing
|
2 Significantly upregulated genes
|
2 Significantly upregulated genes
|
|
Gene Expression
Upregulated genes in ECM integrity
|
1 Significantly upregulated genes
|
1 Significantly upregulated genes
|
Adverse Events
Poly L-Lactic Acid (PLLA)
Calcium Hydroxylapatite (CaHA)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place