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Biologically Active Filler
Sculptra Aesthetic for Nasolabial Folds
N/A
Waitlist Available
Led By Neil Sadick, M.D.
Research Sponsored by Sadick Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 weeks
Summary
This trial is testing Sculptra injections, which use tiny beads to help the skin produce more collagen. It targets patients with facial fat loss from HIV and those with skin defects. The goal is to see if these injections can improve skin quality by making it smoother, more radiant, and more even in color. Sculptra was approved by the FDA in 2004 for the treatment of HIV-associated facial lipoatrophy.
Eligible Conditions
- Nasolabial Folds
- Wrinkles
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Histological effect
Secondary study objectives
Skin Improvement
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1Experimental Treatment1 Intervention
Subjects will receive 3 treatments of 1mL Poly-L-Lactic Acid (Sculptra Aesthetic)
Group II: Group 2Placebo Group1 Intervention
Subjects will receive 3 treatments of 1mL Saline solution.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sculptra Aesthetic
2022
N/A
~500
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Who is running the clinical trial?
Sadick Research GroupLead Sponsor
5 Previous Clinical Trials
109 Total Patients Enrolled
Galderma R&DIndustry Sponsor
302 Previous Clinical Trials
60,627 Total Patients Enrolled
9 Trials studying Nasolabial Folds
493 Patients Enrolled for Nasolabial Folds
Neil Sadick, M.D.Principal InvestigatorSadick Research Group
2 Previous Clinical Trials
216 Total Patients Enrolled
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