Safety and Effectiveness of Sculptra 011611 for Improvement in Appearance of Gluteal Skin Irregularities
NCT ID: NCT07324564
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
125 participants
INTERVENTIONAL
2025-11-24
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment Group
Participants will receive three subcutaneous injection of single regimen of Sculptra 011611. A single regimen consists of up to three injection sessions spaced 1 month (+2 weeks) apart at Baseline, Month 1 and Month 2.
Sculptra 016011
Freeze-dried powder for injection.
Control Group
Participants will be randomized to not receive any intervention.
No interventions assigned to this group
Interventions
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Sculptra 016011
Freeze-dried powder for injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women 18 years of age and older.
* Has intent to undergo treatment to improve skin quality and skin irregularities in the buttock area.
Exclusion Criteria
* Previous treatment/procedure in or near the treatment area OR is planning to undergo any procedures affecting the treatment area, at any time during the study.
* Presence of any disease or lesions near or on the area to be treated.
* Evidence of scar-related disease or delayed healing activity within 1 year prior to the Baseline visit, or participants susceptible to keloid formation, hyperpigmentation or hypertrophic scarring from injectable procedures.
* Skin coloring/bleaching/tattoo/stretch marks in the treatment area, which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessment.
* An underlying known disease, a surgical or medical condition that would expose the participant to undue risk.
* Treatment with chemotherapy, immunosuppressive agents, topical and systemic prescription retinoids, topical and systemic corticosteroids within 3 months before treatment.
18 Years
FEMALE
Yes
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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Site 8688
Vancouver, British Columbia, Canada
Site 7049
Vancouver, British Columbia, Canada
Site 8379
Burlington, Ontario, Canada
Site 8689
Toronto, Ontario, Canada
Site 8162
Woodbridge, Ontario, Canada
Site 8690
Westmount, Quebec, Canada
Countries
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Central Contacts
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Other Identifiers
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43CASA2406
Identifier Type: -
Identifier Source: org_study_id
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