An interventional study of Sculptra new dilution in Cellulite, sponsored by Galderma R&D. Completed at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Galderma R&D (part of Galderma Group AG) · Not applicable, Interventional, and Treatment
This pilot study has been designed to evaluate the safety and effectiveness of PLLA as a single regimen for the improvement in appearance of cellulite after changes in reconstitution procedure.
Cellulite is a topographic and localized skin condition that is commonly found on the posterolateral thighs, buttocks, and abdomen. It is often identified by a dimpled or orange-peel appearance of the skin's surface. The presence of visible cellulite is associated with histologic changes in the dermis, adipose tissue, and septae.
Based on the theory that a stronger skin structure, with a decrease in skin laxity and increase in dermal thickness, could reduce the appearance of cellulite, the Sponsor intends to investigate the safety and effectiveness of PLLA for the improvement in appearance of cellulite in the posterior thighs.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 29 is below the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →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.
Counted across the registry records on this site, refreshed daily.
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:
Previous treatment/procedure in or near the treatment area:
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.
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.
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.
PLLA new dilution for treatment to improve appearance of cellulite.
Device: Sculptra new dilution
Treatment to improve appearance of cellulite.
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9
Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to current visit. On a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 9 were reported.
Time frame: At Month 9
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 1, 2, 6 and 12
Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to a photograph from the current visit. on a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 1,2,6 and 12 were reported.
Time frame: At month 1, 2, 6 and 12
Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed by Participant Photography at Month 1, 2, 6, 9 and 12
Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to a photograph from the current visit. on a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by themselves (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on participant photography assessment using GAIS at Month 1,2,6 and 12 were reported.
Time frame: At Months 1, 2, 6, 9 and 12
This study was conducted at Canada from 19 November 2021 to 27 February 2023.
| Milestone | Treatment Group (Sculptra) |
|---|---|
| Started | 29 |
| Completed | 29 |
| Not completed | 0 |
Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to current visit. On a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 9 were reported.
| Thighs | Treatment Group (Sculptra) |
|---|---|
| Left thigh — Very much improved | 23 |
| Left thigh — Much improved | 4 |
| Left thigh — Improved | 1 |
| Left thigh — No change | 1 |
| Right thigh — Very much improved | 24 |
| Right thigh — Much improved | 3 |
| Right thigh — Improved | 1 |
| Right thigh — No change | 1 |
Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to a photograph from the current visit. on a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on treating investigator assessment using GAIS at Month 1,2,6 and 12 were reported.
| Thighs | Treatment Group (Sculptra) |
|---|---|
| Month 1, Left thigh — Very much improved | 0 |
| Month 1, Left thigh — Much improved | 8 |
| Month 1, Left thigh — Improved | 16 |
| Month 1, Left thigh — No change | 5 |
| Month 1, Right thigh — Very much improved | 1 |
| Month 1, Right thigh — Much improved | 6 |
| Month 1, Right thigh — Improved | 17 |
| Month 1, Right thigh — No change | 5 |
| Month 2, Left thigh — Very much improved | 2 |
| Month 2, Left thigh — Much improved | 8 |
| Month 2, Left thigh — Improved | 19 |
| Month 2, Left thigh — No change | 0 |
| Month 2, Right thigh — Very much improved | 2 |
| Month 2, Right thigh — Much improved | 8 |
| Month 2, Right thigh — Improved | 19 |
| Month 2, Right thigh — No change | 0 |
| Month 6, Left thigh — Very much improved | 16 |
| Month 6, Left thigh — Much improved | 7 |
| Month 6, Left thigh — Improved | 6 |
| Month 6, Left thigh — No change | 0 |
| Month 6, Right thigh — Very much improved | 16 |
| Month 6, Right thigh — Much improved | 6 |
| Month 6, Right thigh — Improved | 7 |
| Month 6, Right thigh — No change | 0 |
| Month 12, Left thigh — Very much improved | 18 |
| Month 12, Left thigh — Much improved | 10 |
| Month 12, Left thigh — Improved | 1 |
| Month 12, Left thigh — No change | 0 |
| Month 12, Right thigh — Very much improved | 19 |
| Month 12, Right thigh — Much improved | 8 |
| Month 12, Right thigh — Improved | 2 |
| Month 12, Right thigh — No change | 0 |
Aesthetic improvement was assessed by comparing a photograph taken before the first treatment at the baseline visit to a photograph from the current visit. on a 7-graded GAIS from "very much worse" to "very much improved" as follows; very much improved, much improved, improved, no change, worse, much worse and very much worse. Responder was defined as a participant with a rating of at least improved as assessed by themselves (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of aesthetic improved thighs of responders based on participant photography assessment using GAIS at Month 1,2,6 and 12 were reported.
| Thighs | Treatment Group (Sculptra) |
|---|---|
| Month 1, Left thigh — Very much improved | 2 |
| Month 1, Left thigh — Much improved | 3 |
| Month 1, Left thigh — Improved | 19 |
| Month 1, Left thigh — No change | 5 |
| Month 1, Right thigh — Very much improved | 2 |
| Month 1, Right thigh — Much improved | 2 |
| Month 1, Right thigh — Improved | 20 |
| Month 1, Right thigh — No change | 5 |
| Month 2, Left thigh — Very much improved | 5 |
| Month 2, Left thigh — Much improved | 8 |
| Month 2, Left thigh — Improved | 14 |
| Month 2, Left thigh — No change | 2 |
| Month 2, Right thigh — Very much improved | 4 |
| Month 2, Right thigh — Much improved | 9 |
| Month 2, Right thigh — Improved | 14 |
| Month 2, Right thigh — No change | 2 |
| Month 6, Left thigh — Very much improved | 6 |
| Month 6, Left thigh — Much improved | 9 |
| Month 6, Left thigh — Improved | 11 |
| Month 6, Left thigh — No change | 2 |
| Month 6, Right thigh — Very much improved | 6 |
| Month 6, Right thigh — Much improved | 8 |
| Month 6, Right thigh — Improved | 13 |
| Month 6, Right thigh — No change | 1 |
| Month 9, Left thigh — Very much improved | 11 |
| Month 9, Left thigh — Much improved | 5 |
| Month 9, Left thigh — Improved | 11 |
| Month 9, Left thigh — No change | 2 |
| Month 9, Right thigh — Very much improved | 11 |
| Month 9, Right thigh — Much improved | 5 |
| Month 9, Right thigh — Improved | 12 |
| Month 9, Right thigh — No change | 1 |
| Month 12, Left thigh — Very much improved | 12 |
| Month 12, Left thigh — Much improved | 5 |
| Month 12, Left thigh — Improved | 10 |
| Month 12, Left thigh — No change | 2 |
| Month 12, Right thigh — Very much improved | 11 |
| Month 12, Right thigh — Much improved | 6 |
| Month 12, Right thigh — Improved | 10 |
| Month 12, Right thigh — No change | 2 |
Collected over Up to 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group (Sculptra) | 0/29 (0%) | 0/29 (0%) | 10/29 (34.5%) |
| Event | Treatment Group (Sculptra) |
|---|---|
| NasopharyngitisInfections and infestations | 3/29 |
| COVID-19Infections and infestations | 2/29 |
| BronchitisInfections and infestations | 1/29 |
| SinusitisInfections and infestations | 1/29 |
| Urinary tract infectionInfections and infestations | 1/29 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 1/29 |
| Urethral prolapseRenal and urinary disorders | 1/29 |
| Age, Continuous(years) | Treatment Group (Sculptra) |
|---|---|
| Mean | 41.2 ± 9.01 |
| Sex: Female, Male(Participants) | Treatment Group (Sculptra) |
|---|---|
| Female | 29 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Treatment Group (Sculptra) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 27 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Treatment Group (Sculptra) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 23 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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