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Injectable
Sculptra Aesthetic Side for Cellulite
N/A
Waitlist Available
Led By Sabrina Fabi, MD
Research Sponsored by Goldman, Butterwick, Fitzpatrick and Groff
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy adult females age 30 to 60
Both buttocks and/or both posterolateral thighs with a score of mild (1-5) to moderate (6-10 according to the Hexsel, Dal'Forno & Hexsel Cellulite Severity Scale (CSS), and a laxity score using the Hexsel, Dal'Forno & Hexsel Cellulite Severity Scale of 1 (slight) or 2 (moderate). Must be the same score on both sides of the same area (ie: if 1 on one buttock, must be 1 on the other buttock but can be a 2 on the thigh, as long as the other thigh is also a 2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This study is evaluating whether a treatment for cellulite may be effective.
Eligible Conditions
- Cellulite
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessing Efficacy
Assessing Patient Satisfaction
Assessing Safety
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Sculptra Aesthetic SideActive Control1 Intervention
the treatment area side (an area side is considered either buttock and/or thigh) (left or right-depends on randomization) will receive up to two vials of Sculptra Aesthetic, for a total of 4 vials in one treatment session if 2 areas qualify.
Group II: Placebo sidePlacebo Group1 Intervention
the treatment area side (an area side is considered either buttock and/or thigh) (left or right-depends on randomization) will receive 16 cc of bacteriostatic water, for up to 64 ccs of bacteriostatic water to match the volume injected on the active side
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Who is running the clinical trial?
Goldman, Butterwick, Fitzpatrick and GroffLead Sponsor
28 Previous Clinical Trials
570 Total Patients Enrolled
Galderma R&DIndustry Sponsor
295 Previous Clinical Trials
60,192 Total Patients Enrolled
2 Trials studying Cellulite
49 Patients Enrolled for Cellulite
Sabrina Fabi, MDPrincipal InvestigatorCosmetic Laser Dermatology
2 Previous Clinical Trials
335 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Texas
California
What site did they apply to?
Cosmetic Laser Dermatology/West Dermatology Research Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1
3+
Why did patients apply to this trial?
Want additional help with body image . I've tried several treatments in the past that haven't really worked for me.
PatientReceived no prior treatments
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