Gene ExpressionSculptraNCT05620043
Gene Expression Study Between Two Dermal Injectables Hydroxylapatite Semi-permanent Filler
A study testing Sculptra and Radiesse Plus in people with Gene Expression, run by Galderma R&D at 1 site in United States.
Trial summary
To compare gene expression stimulated by a semi-permanent filler and a biostimulator via punch biopsy Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gene Expression
- What is being tested?
- Sculptra and Radiesse Plus
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2022to 6 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Miami Dermatology & Laser Institute
Miami, Florida, 33173
About this study
Official title: A Randomized, Single-center, Prospective Biopsy Study Comparing a Poly L-lactic Acid Biostimulator and a Calcium Hydroxylapatite Semi-permanent Filler
To compare gene expression stimulated by a semi-permanent filler and a biostimulator via punch biopsy
Read the 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.
- Conditions
- Gene Expression
- Being tested
- Sculptra, Radiesse Plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SculptraDevice
Biostimulator
Radiesse PlusDevice
Semi-permanent filler
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Radiesse Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start28 Sep 2022
- Primary completion25 Jul 2023
- Study completion6 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gene ExpressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-center, comparative study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jill S Waibel, MD, Principal investigator, Miami Dermatology & Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620043
- Sponsor's protocol ID
- GLI.04.US.SL.020
- Acronym
- Sculptra
- Status last verified
- Apr 2026
- First submitted
- 7 Nov 2022
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39480040
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-center, Prospective Biopsy Study Comparing a Poly L-lactic Acid Biostimulator and a Calcium Hydroxylapatite Semi-permanent Filler
- ClinicalTrials.gov ID
- NCT05620043
- Acronym / sponsor ID
- Sculptra / GLI.04.US.SL.020
- Conditions
- Gene Expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Posted 15 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, single-center, comparative study
| Arm | Type | Receives |
|---|---|---|
| Poly L-Lactic Acid (PLLA) | Active comparator | Device: SculptraLyophilized PLLA with sodium carboxymethylcellulose, non-pyrogenic mannitol. Treatment needs to be reconstituted prior to injection, following product instruction. |
| Calcium Hydroxylapatite (CaHA) | Active comparator | Device: Radiesse PlusOpaque, 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. |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SculptraBiostimulator | Device | Poly L-Lactic Acid (PLLA) |
| Radiesse PlusSemi-permanent filler | Device | Calcium Hydroxylapatite (CaHA) |
Primary outcome
Gene Expression
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39480040Waibel 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.
- Individual participant dataSharing planned: No
Related trials for Gene Expression
RecruitingObservational study
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Endocrine Tumors, Thyroid Neoplasms
Active, not recruitingPhase 2/3
Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas
Diffuse Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Not yet recruitingObservational study
Age-Related Inflammatory Proteins as Indicators of Vital Pulp Therapy Outcomes
Vital Pulp Therapy
RecruitingObservational study
Characterization of CD180 Protein Expression in Myeloid Hematological Malignancies by Flow Cytometry
Acute Myeloid Leukemia, Myeloid Hematological Malignancies
RecruitingPhase 1
NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors
Advanced Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill S Waibel, MD principal investigator
Miami Dermatology & Laser Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sculptra and Radiesse Plus in people with Gene Expression, run by Galderma R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene Expression (time frame: 12 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05620043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.