PhotoagingNCT06351358
Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies
A study testing Sculptra treatment and Restylane Treatment in people with Photoaging and Weight Loss, run by Galderma R&D at 2 sites in United States.
Trial summary
Adult subjects with a history of or currently taking glucagon-like peptide-1 (GLP-1) receptor agonist medication and moderate-to-severe cheek wrinkles and midface contour deficiencies will be treated with Sculptra correction of fine lines and wrinkles in the cheek area and Restylane Lyft or Restylane Contour for cheek… Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Photoaging, Weight Loss, Skin Laxity
- What is being tested?
- Sculptra treatment and Restylane Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Feb 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any Fitzpatrick skin types I-VI, with effort to include minimum n = 1 for each category per site
- Any races and ethnicities, with effort to include minimum n = 2 per site for whom identify as American Indian or Alaska Native, Eastern/Southeastern Asian, South Asians, Hispanic or Latino, Black or African American, Native Hawaiian or Other Pacific Islander, etc.
- Subject with moderate-to-severe cheek wrinkles on the GCWS
- Subject with mild-to-severe midface contour deficiencies on the MMVS
- Subject with intent to undergo correction of cheek augmentation or midface contour deficiencies.
- Subject with history of taking or currently taking GLP-1 receptor agonist medications such as semaglutide, liraglutide, etc.
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- Subject with stable Body Mass Index (BMI) within 4-6 weeks before study start.
- Subject willing to maintain a stable Body Mass Index (BMI, ± 2 kg/m2) throughout the study.
- Willing to maintain the current lifestyle and daily routine (e.g., diet, exercise, sleep, etc.) throughout the study.
- Subject willing to be photographed at each visit.
- Subject willing to abstain from any other facial plastic surgical or cosmetic procedure(s) during the duration of the study.
- For female subjects of childbearing potential, she agrees to use an acceptable form of effective birth control for the duration of the study. Subjects must be willing to take a urine pregnancy test (UPT) prior to all treatments. (Females of non-childbearing potential, e.g., post-menopausal (absence of menstrual bleeding for 1 year without any other medical reason), hysterectomy, or bilateral ovariectomy, are not required to have a UPT.)
- Male subjects must be willing to shave prior to each study visit.
- Ability to read, understand and give consent for participation in the study.
- Agreement to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments.
Who cannot join
- Pregnant, breastfeeding, or planning pregnancy during the course of the study.
- Current smokers or consumer of nicotine.
- History of allergy or hypersensitivity to any ingredient of the treatment products, anesthetics or lidocaine
- Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions
- Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except the lips
- History of injectable polymethylmethacrylate (PMMA) treatment
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- Previous treatment/procedure in the face in the previous 6 months that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures in the treatment area at any time during the study
- Presence of any disease or lesions near or on the area to be treated
- History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation (e.g., aspirin or other non-steroidal anti-inflammatory drugs), omega 3, or vitamin E within 14 days before treatment. Omega 3 and vitamin E are acceptable only as part of a standard multivitamin formulation.
- Previous surgery, including plastic surgery, lifting threads, tissue grafting, or tissue augmentation with permanent implants, silicone, tattoo affecting the treatment area, or any procedure, at the discretion of the Investigator, would interfere with the outcome of the study.
- Any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion
- Other condition preventing the subject from entering the study in the Investigator's opinion
- Study site personnel, close relatives of the study site personnel (e.g., parents, children, siblings, or spouse), or employees and close relatives of employees at the Sponsor company.
- Participation in any interventional clinical study within 30 days of screening.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lorenc Aesthetic Plastic Surgery Center
New York, New York, 10028
Somenek + Pittman MD: Advanced Plastic Surgery
Washington D.C., District of Columbia, 20037
About this study
Official title: A Multi-center, Open-label Study to Evaluate the Synergistic Effects of Biostimulator and Dermal Fillers for Cheek Augmentation and Correction of Contour Deficiencies
Adult subjects with a history of or currently taking glucagon-like peptide-1 (GLP-1) receptor agonist medication and moderate-to-severe cheek wrinkles and midface contour deficiencies will be treated with Sculptra correction of fine lines and wrinkles in the cheek area and Restylane Lyft or Restylane Contour for cheek augmentation and correction of midface contour deficiencies.
Read the detailed description
This is a multi-center, open-label study. Subjects will be screened on the basis of the selection criteria for study qualification. Eligible subjects will have initial treatment of Sculptra and Restylane Lyft or Restylane Contour on both cheeks at the Baseline visit.
At Week 4, subjects will receive a second Sculptra treatment on both cheeks for optimal correction and an optional touch-up of Restylane Lyft or Restylane Contour for optimal correction, defined as at least a 1-grade improvement on the GCWS and MMVS.
At Week 8, subjects will receive an optional Sculptra treatment on both cheeks for optimal correction.
Subjects will have follow-up visits at Week 16, Week 28, and Week 40 if the last Sculptra treatment is at Week 4 or at Week 20, Week 32, and Week 44 if the last Sculptra treatment is at Week 8.
- Being tested
- Sculptra treatment, Restylane Treatment
- Medical subject headings
- Weight Loss, Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sculptra treatmentDevice
Subjects will receive treatment of Sculptra at baseline. Subjects will receive a second treatment of Sculptra at Week 4 visit. At the Week 8 visit, subjects will receive an optional treatment of Sculptra.
Restylane TreatmentDevice
Subjects will receive treatment Restylane Lyft or Restylane Contour at baseline. Subjects will receive an optional touch-up of Restylane Lyft or Restylane Contour at Week 4 visit.
| Study group | Role | What they receive |
|---|---|---|
| Sculptra and Restylane Treatment Group | Experimental | Subjects in the treatment group will receive the intervention with Sculptra and Restylane Lyft or Restylane Contour. Receives: Device: Sculptra treatment; Device: Restylane Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin hydration from baseline
Corneometer (Courage + Khazaka, Germany) measurements will be taken in triplicate to assess skin hydration. The Corneometer measures in Corneometer units from 0 (no water at all) - 120 (on water).The locations of measurement will be at (1) the zygoma area in the Restylane-treated region using a ruler starting from the corner of the eye and (2) 2-3 cm laterally from the end of the earlobe in the Sculptra-injected region using a ruler starting from the end of the earlobe to the corner of the mouth. An increase in scores indicates an improvement.
Measured: Baseline, Week 4, Week 8, Week 16 or Week 20
Change in skin radiance from baseline
Glossymeter (Courage + Khazaka, Germany) measurements will be taken to assess skin radiance. The results will be expressed in Glossymeter units. The locations of measurement will be at (1) the zygoma area in the Restylane-treated region using a ruler starting from the corner of the eye and (2) 2-3 cm laterally from the end of the earlobe in the Sculptra-injected region using a ruler starting from the end of the earlobe to the corner of the mouth. An increase in scores indicates an improvement.
Measured: Baseline, Week 4, Week 8, Week 16 or Week 20
Change in skin elasticity from baseline
Cutometer (Courage + Khazaka, Germany) measurements will be taken to assess skin elasticity. The Cutometer measures skin elasticity in mm penetration depth per unit of time. The locations of measurement will be at (1) the zygoma area in the Restylane-treated region using a ruler starting from the corner of the eye and (2) 2-3 cm laterally from the end of the earlobe in the Sculptra-injected region using a ruler starting from the end of the earlobe to the corner of the mouth. An increase in scores indicates an improvement.
Measured: Baseline, Week 4, Week 8, Week 16 or Week 20
Change in skin thickness from baseline
DermaLab® Ultrasound (Cortex Technology, Denmark) measurements will be taken in triplicate to assess skin thickness in µm. The locations of measurement will be at (1) the zygoma area in the Restylane-treated region using a ruler starting from the corner of the eye and (2) 2-3 cm laterally from the end of the earlobe in the Sculptra-injected region using a ruler starting from the end of the earlobe to the corner of the mouth. An increase in scores indicates an improvement.
Measured: Baseline, Week 4, Week 8, Week 16 or Week 20
Secondary outcomes (1)
Subject Treatment Satisfaction
Subjects will be asked about their perception and satisfaction with the study treatments using a self-assessment questionnaire at each visit after Baseline. Questionnaires will be tabulated; and the frequency and percentage of all response options will be reported for each question and time point. Favorable responses (i.e., strongly agree and agree, yes), neutral responses (i.e., neither agree nor disagree, no difference), and unfavorable responses (i.e., strongly disagree and disagree, no) will be tabulated and reported as appropriate.
Measured: Week 4, Week 8, Week 16 or Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start19 Feb 2024
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotoagingStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Somenek, MD, Principal investigator, Somenek + Pittman MD: Advanced Plastic SurgeryPaul Z Lorenc, MD, Principal investigator, Z. Paul Lorenc Aesthetic Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351358
- Sponsor's protocol ID
- GLI.04.US.SL.036
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 Multi-center, Open-label Study to Evaluate the Synergistic Effects of Biostimulator and Dermal Fillers for Cheek Augmentation and Correction of Contour Deficiencies
- ClinicalTrials.gov ID
- NCT06351358
- Acronym / sponsor ID
- GLI.04.US.SL.036
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adult subjects with a history of or currently taking glucagon-like peptide-1 (GLP-1) receptor agonist medication and moderate-to-severe cheek wrinkles and midface contour deficiencies will be treated with Sculptra correction of fine lines and wrinkles in the cheek area and Restylane Lyft or Restylane Contour for cheek augmentation and correction of midface contour deficiencies.
Detailed description
This is a multi-center, open-label study. Subjects will be screened on the basis of the selection criteria for study qualification. Eligible subjects will have initial treatment of Sculptra and Restylane Lyft or Restylane Contour on both cheeks at the Baseline visit.
At Week 4, subjects will receive a second Sculptra treatment on both cheeks for optimal correction and an optional touch-up of Restylane Lyft or Restylane Contour for optimal correction, defined as at least a 1-grade improvement on the GCWS and MMVS.
At Week 8, subjects will receive an optional Sculptra treatment on both cheeks for optimal correction.
Subjects will have follow-up visits at Week 16, Week 28, and Week 40 if the last Sculptra treatment is at Week 4 or at Week 20, Week 32, and Week 44 if the last Sculptra treatment is at Week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sculptra and Restylane Treatment Group | Experimental | Device: Sculptra treatment, Device: Restylane TreatmentSubjects in the treatment group will receive the intervention with Sculptra and Restylane Lyft or Restylane Contour. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Any Fitzpatrick skin types I-VI, with effort to include minimum n = 1 for each category per site
- Any races and ethnicities, with effort to include minimum n = 2 per site for whom identify as American Indian or Alaska Native, Eastern/Southeastern Asian, South Asians, Hispanic or Latino, Black or African American, Native Hawaiian or Other Pacific Islander, etc.
- Subject with moderate-to-severe cheek wrinkles on the GCWS
- Subject with mild-to-severe midface contour deficiencies on the MMVS
- Subject with intent to undergo correction of cheek augmentation or midface contour deficiencies.
Key exclusion criteria (14 listed)
- Pregnant, breastfeeding, or planning pregnancy during the course of the study.
- Current smokers or consumer of nicotine.
- History of allergy or hypersensitivity to any ingredient of the treatment products, anesthetics or lidocaine
- Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions
- Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except the lips
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 |
|---|---|---|
| Sculptra treatmentSubjects will receive treatment of Sculptra at baseline. Subjects will receive a second treatment of Sculptra at Week 4 visit. At the Week 8 visit, subjects will receive an optional treatment of Sculptra. | Device | Sculptra and Restylane Treatment Group |
| Restylane TreatmentSubjects will receive treatment Restylane Lyft or Restylane Contour at baseline. Subjects will receive an optional touch-up of Restylane Lyft or Restylane Contour at Week 4 visit. | Device | Sculptra and Restylane Treatment Group |
Primary outcome
Change in skin hydration from baseline
Time frame: Baseline, Week 4, Week 8, Week 16 or Week 20
Corneometer (Courage + Khazaka, Germany) measurements will be taken in triplicate to assess skin hydration. The Corneometer measures in Corneometer units from 0 (no water at all) - 120 (on water).The locations of measurement will be at (1) the zygoma area in the Restylane-treated region using a ruler starting from the corner of the eye and (2) 2-3 cm laterally from the end of the earlobe in the Sculptra-injected region using a ruler starting from the end of the earlobe to the corner of the mouth. An increase in scores indicates an improvement.
Change in skin radiance from baseline
Time frame: Baseline, Week 4, Week 8, Week 16 or Week 20
Glossymeter (Courage + Khazaka, Germany) measurements will be taken to assess skin radiance. The results will be expressed in Glossymeter units. The locations of measurement will be at (1) the zygoma area in the Restylane-treated region using a ruler starting from the corner of the eye and (2) 2-3 cm laterally from the end of the earlobe in the Sculptra-injected region using a ruler starting from the end of the earlobe to the corner of the mouth. An increase in scores indicates an improvement.
Change in skin elasticity from baseline
Time frame: Baseline, Week 4, Week 8, Week 16 or Week 20
Cutometer (Courage + Khazaka, Germany) measurements will be taken to assess skin elasticity. The Cutometer measures skin elasticity in mm penetration depth per unit of time. The locations of measurement will be at (1) the zygoma area in the Restylane-treated region using a ruler starting from the corner of the eye and (2) 2-3 cm laterally from the end of the earlobe in the Sculptra-injected region using a ruler starting from the end of the earlobe to the corner of the mouth. An increase in scores indicates an improvement.
Change in skin thickness from baseline
Time frame: Baseline, Week 4, Week 8, Week 16 or Week 20
DermaLab® Ultrasound (Cortex Technology, Denmark) measurements will be taken in triplicate to assess skin thickness in µm. The locations of measurement will be at (1) the zygoma area in the Restylane-treated region using a ruler starting from the corner of the eye and (2) 2-3 cm laterally from the end of the earlobe in the Sculptra-injected region using a ruler starting from the end of the earlobe to the corner of the mouth. An increase in scores indicates an improvement.
1 secondary outcome
Subject Treatment Satisfaction
Time frame: Week 4, Week 8, Week 16 or Week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Michael Somenek, MD principal investigator
Somenek + Pittman MD: Advanced Plastic Surgery
Paul Z Lorenc, MD principal investigator
Z. Paul Lorenc Aesthetic Plastic Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sculptra treatment and Restylane Treatment in people with Photoaging and Weight Loss, run by Galderma R&D at 2 sites 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 15 inclusion and 14 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 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in skin hydration from baseline (time frame: Baseline, Week 4, Week 8, Week 16 or Week 20). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.