Clinical Research Directory

Safety and Efficacy of Deoxycholate Treatment of Small Fatty Deformities ( SFD)

Sponsor: The Maas Clinic

Summary

The purpose of this study is to evaluate the efficacy and safety of deoxycholate for the treatment of lipocytic ("fatty") deformities of the trunk and lower extremities; this includes areas such as cellulite or body contour deformities following liposuction. Ten participants will be enrolled in the pilot (part 1) portion of this study, and 60 participants will be enrolled in part 2 of this study (the blinded study). Those who are eligible to be in the pilot (part 1) study will receive an injection with deoxycholate \[concentration of 10 mg/mL (1.0%)\] directly into the zone of fatty deformity. Those who are eligible to be in the second part of this study will be randomly assigned to receive an injection with deoxycholate \[concentration of 10 mg/mL (1.0%)\] to one fatty deformity site, and an injection with a placebo (0.9% benzyl alcohol) without deoxycholate to a separate fatty deformity site. Thus, at each treatment session, participants will receive an injection with deoxycholate to one lipocytic deformity site, and an injection with a placebo to a separate (similar appearing) fatty deformity site. The placebo is provided for the comparator group. Subsequent treatment visits will be conducted at approximately 28-day intervals for up to 5 treatment sessions (Visits 2, 3, 4, and 5 \[±5 days, relative to the date of the previous treatment session\]). Approximately 7 (±3) days after each treatment visit, participants will be required to come to the research site for Visits 1A, 2A, 3A, 4A, and 5A (relative to each treatment session) for evaluations of the treatment area, recording of vital signs and weight, and to update records on adverse events and concomitant medications. A post-treatment follow-up visit at 6 months (Visit 6 on Day 168) relative to the date of the initial treatment session will be required.

Official title: Split-Body Study to Evaluate the Safety and Efficacy of Deoxycholate for the Treatment of Lipocytic Deformities of the Trunk and Lower Extremities

Key Details

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Interventions