An interventional study of Sculptra treatment and Restylane Treatment in Photoaging, Weight Loss and Skin Laxity, sponsored by Galderma R&D. Completed at 2 sites in United States. Open to participants aged 22 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Galderma R&D (part of Galderma Group AG) · Not applicable, Interventional, and Treatment
Among 995 studies in Weight Loss with a site in United States — 114 open to participants now, 169 under way, 6 of them phase 3. Weight Loss · United States.
Among the 995 studies in Weight Loss with a site in United States, this one is the 618th largest by enrollment of the 912 interventional ones that give a count, is one of 43 that started in 2024, is one of 714 with no phase, and was the 869th registered.
1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.
Browse Weight Loss studies →114 of the 995 studies in Weight Loss with a site in United States are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States
Icahn School of Medicine at Mount Sinai · Sites in United States
Morehouse School of Medicine · Sites in United States
Duke University · Sites in United States
Viking Therapeutics, Inc. · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 196 Weight Loss studies recruiting now, 71 (36%) set no upper age limit and 108 (55%) stop at 75 or younger; 21 take children under 18; 58 take healthy volunteers.
This study: 22 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
995 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 48 · Phase 2 106 · Phase 3 38 · Phase 4 33
First in 1996; this study’s year is marked. 43 started in 2024.
This study's enrollment of 41 is below the median of 80 across 1,561 interventional studies indexed under Weight Loss.
Median enrollment 72 across the 912 interventional studies, 99 across the 76 observational. Of the 769 that completed or were terminated, 230 (30%) have results posted.
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116 of 995 have an industry lead sponsor. The 10 most frequent:
Galderma R&D is the lead sponsor of 284 studies on the registry; 11 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 55 (92%) have results posted.
Galderma R&D has 1 study filed under Weight Loss — fewer than ten, so there is no comparison to draw.
57 of the studies in Weight Loss with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07298915Phase 3University of VirginiaThe Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED) | 2026-12 |
| NCT07223242Phase 3University of Texas Southwestern Medical CenterTailored Exercise Training Study Among Adults With HFpEF | 2026-12-30 |
| NCT07104383Phase 3Viking Therapeutics, Inc.VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2) | 2027-07-01 |
| NCT07104500Phase 3Viking Therapeutics, Inc.VK2735 for Weight Management Phase 3 | 2027-07-01 |
| NCT07560579Million Marker Wellness, Inc.Weight Loss and Endocrine Disrupting Chemicals (EDCs): Lifestyle Interventions to Lose Weight and Reduce EDC Exposure in Individuals With Overweight/Obesity | 2026-11 |
Among the 995 studies in Weight Loss with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in the treatment group will receive the intervention with Sculptra and Restylane Lyft or Restylane Contour.
Device: Sculptra treatment · Device: Restylane Treatment
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 4, Week 8, Week 16 or Week 20
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.
Time frame: Week 4, Week 8, Week 16 or Week 20
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2024 to primary completion in May 2025, 15 months.
Of 59 industry-sponsored interventional studies with no phase under Weight Loss, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's 15 months is above that.
Counting every sponsor, half of 729 studies reached it within 24 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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