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SFD
Split-Body Study to Evaluate the Safety and Efficacy of Deoxycholate for the Treatment of Lipocytic Deformities of the Trunk and Lower Extremities
Sponsor study identifier
interventional
37
1 country
1
Study Start
February 20, 2018
Actual (reported)Primary Completion
December 25, 2020
Actual (reported)Study Completion
December 25, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 25, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 5, 2017
Actual (reported)February 20, 2018
Actual (reported)December 25, 2020
Actual (reported)December 25, 2021
Actual (reported)October 19, 2026
Actual (reported)Clinician-Reported Cellulite Grading Scale (CR-CGS) - Assessing Change in Appearance of Lipocytic Deformity
Grading performed by investigator using the 4-point Nürnberger and Müller Lipocytic Deformities Grading Scale, assessing the appearance of the zone of lipocytic deformity.
Will be measured every 30 days up to 7 months.
Patient-Reported Visual Analog Scale - Assessing Change in Appearance of Lipocytic Deformity
Grading performed by subject using the 10-point Visual Analog Grading Scale, assessing the appearance of the zone of lipocytic deformity.
Will be measured every 30 days up to 7 months.
Subject Global Questions
Up to 7 months
Photography
Photos will be taken day: 0, 7, 14, 28, 35, 42, 56, 84, 112, 140, 168, and 196 (up to 7 months)
Each subject receives both active intervention (Kybella) and placebo treatment in this arm.
Less than or equal to 2 mg/cm\^2 sodium deoxycholate subcutaneous injection into the zone of lipocytic deformity every four weeks for up to five treatments.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Maas Clinic Research Center
San Francisco, California, 94115, United States
Corey S Maas, M.D.
The Maas Clinic
37 participants (actual enrollment reported by the registry).
First Submitted
July 5, 2017
Contact the study team to confirm eligibility.
First Posted
October 19, 2026
Study Start
February 20, 2018
Actual (reported)Primary Completion
December 25, 2020
Actual (reported)Study Completion
December 25, 2021
Actual (reported)Last Updated
October 19, 2026
Record last verified: 2026-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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