Deformity; SkinPhase 4SFDNCT07880301
Safety and Efficacy of Deoxycholate Treatment of Small Fatty Deformities ( SFD)
A Phase 4 study testing Kybella in people with Deformity; Skin and Fat Redistribution, run by The Maas Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Deformity; Skin, Fat Redistribution, Lipodystrophy
- What is being tested?
- Kybella
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2018to 25 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with Grade I, II, or III cellulite (based on the Nurnberger \& Muller Scale) by physician assessment, affecting less than or equal to 10 cm2 surface area, and / or the presence of post surgical deformities associated with liposuction.
- Males and nonpregnant, nonlactating females 18 to 55 years of age, inclusive, on the day of randomization (Visit 1). Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before Visit 1 and agree to practice adequate contraception, in the judgment of the investigator, during the course of the study. Females of childbearing potential who are not sexually active need not practice contraception.
- Time and ability to complete the study and comply with instructions.
- Understanding of the study and contents of the informed consent.
- History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization.
- Expected to understand and agree to comply with the visit schedule and all protocol specified tests and procedures and agreement by the subject to refrain from making significant changes, in the judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation.
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- Agreement to forgo any treatment or behavior (e.g., unshaven body hair) during the subject's participation in the study that may affect the assessments of the zones of area.
- Medically able to undergo the administration of study material determined by clinical and laboratory tests obtained within 28 days before randomization for which the investigator identified no clinically significant abnormality.
- Signed informed consent obtained before any study-specific procedure is performed.
Who cannot join
- Patients who present with adipose tumors (lipoma)
- Human immunodeficiency virus (HIV)- or medication-related lipodystrophies
- Concurrent therapy that, in the investigator's opinion, would interfere with evaluation of the efficacy or safety of the medication.
- Active infection involving the fatty deformity zones.
- Pregnant women, nursing mothers, or women who are planning pregnancy during the study, or think they may be pregnant at the start of the study. Throughout the course of the study, women of childbearing potential must use reliable forms of contraception (e.g. abstinence, oral contraceptives for more than 12 consecutive weeks prior to enrollment, or spermicide and condoms).
- Current history of chronic drug or alcohol abuse.
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- Clinically diagnosed anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that, in the opinion of the investigator, might interfere with the patient's participation in the study.
- History of any intervention to treat cellulite (e.g., liposuction, surgery, laser, or lipolytic agents).
- History of trauma associated with the cellulite areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.
- Body mass index of >40.0 as determined on Visit 1.
- A result on coagulation tests (PT, PTT) obtained within 28 days before randomization that indicates the presence of any clinically significant bleeding disorder.
- Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent.
- Treatment with radio frequency or laser procedures in the cellulite zones within 12 months before randomization.
- History of sensitivity to any components of the study material
- History of sensitivity to topical or local anesthetics (e.g., lidocaine, benzocaine, procaine).
- Previous participation in a deoxycholate trial.
- Treatment with an investigational device or agent within 30 days before randomization.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Maas Clinic Research Center
San Francisco, California, 94115
About this study
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
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.
Read more
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.
Read the detailed description
In the pilot portion of the study:
- 10 participants (either male or female, between 18-55 years old ) with lipoocytic deformities of the lower extremities or trunk will receive unilateral treatment with deoxycholate (less than or equal to 2mg/cm2) to assess for safety and proof of concept; this includes participants who have less than or equal to 10-cm2 area of grade I, II, or III cellulite (based on the Nurnberger \& Muller grading scale), and / or post-surgical deformities associated with liposuction.
- Participants will receive less than or equal to 2mg/cm2 deoxycholate in this study. This dose has been shown in previous large scale clinical trials evaluating deoxycholate injections to the submental fat to be a safe and effective dose for treatment with minimal side effects.
- Injections will be 1.0cm apart, 0.2mL/injection into the fatty deformity zone.
- Participants may be injected every 4 weeks for up to 2 treatments.
- The participants will be followed closely for 6 months after the last treatment session to assess the safety and efficacy of deoxycholate. Follow up visits are conducted at Day 7, 14, 28, 35, 42, 56, 84, 112, 140, 168, and 196.
- If the pilot participants show any improvement (1-point improvement on the Nurnberger Muller Lipocytic Deformities grading scale or a 20% improvement on the linear analog scale) in their fatty deformity within the first 2 months after receiving the initial deoxycholate treatment, the investigator will continue with the split-body, placebo-controlled portion of the study (study part 2). Please note that participants enrolled in the pilot study may also be eligible for enrollment in the placebo-controlled study if the participant has more than 2 other fatty deformities.
Part 2, single-center, prospective, double blind, split body study:
- 60 participants (either male or female participants 18 years of age or older) with lipocytic deformities of the lower extremities or trunk will receive injections with deoxycholate and placebo. Participants must have at least two lipocytic deformities that are of a similar nature, and less than or equal to 10cm2 in surface area. This includes participants with grade I, II, or III cellulite (on the Nurnberger Muller Scale) and/or post surgical deformities associated with liposuction.
- These two or more sites will be labeled numerically and blinded, and participants will be randomized to receive injections of deoxycholate (site # 1), and placebo (site # 2) or vice versa to lipocytic deformity zones.
- Participants will receive no more than 10 mL in any treatment session and will not undergo more than 5 treatments. Participants may be injected every 4 weeks for up to 5 treatments.
- All participants will undergo treatment as follows:
- Placebo: 0.2mL / injection to a zone of lipocytic deformity, approximately 1.0cm apart. Patients may be injected every 4 weeks for up to 5 treatments; no participant will receive more than 10 mL in any treatment session
- Deoxycholate (2mg/cm2): 0.2mL / injection to a zone of lipocytic deformity, approximately 1.0cm apart. Participants may be injected every 4 weeks for up to 5 treatments; no participant will receive more than 10 mL in any treatment session
- Study duration: 6 months with 11 Visits
- Conditions
- Deformity; Skin, Fat Redistribution, Lipodystrophy
- Being tested
- Kybella
- Medical subject headings
- Skin Abnormalities, Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KybellaDrug
Also called Deoxycholate, Sodium deoxycholate
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.
| Study group | Role | What they receive |
|---|---|---|
| All Subjects Enrolled | Experimental | Each subject receives both active intervention (Kybella) and placebo treatment in this arm. Receives: Drug: Kybella |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Will be measured every 30 days up to 7 months.
Secondary outcomes (1)
Subject Global Questions
Global assessment of patient satisfaction based upon an analog linear scale.
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start20 Feb 2018
- Primary completion25 Dec 2020
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deformity; SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In the pilot portion of this study, 10 participants will receive treatment with deoxycholate into the zone of lipocytic deformity. In part two of this study, 60 participants with at least two lipocytic deformities will receive injections with deoxycholate into one zone of lipocytic deformity and placebo into the other zone of lipocytic deformity.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Maas Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corey S. Maas, M.D., The Maas Clinic
- Investigators
- Corey S Maas, M.D., Principal investigator, The Maas Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880301
- Sponsor's protocol ID
- DX-2015
- Acronym
- SFD
- Status last verified
- Oct 2026
- First submitted
- 5 Jul 2017
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07880301
- Acronym / sponsor ID
- SFD / DX-2015
- Conditions
- Deformity; Skin, Fat Redistribution, Lipodystrophy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The Maas ClinicUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the pilot portion of the study:
- 10 participants (either male or female, between 18-55 years old ) with lipoocytic deformities of the lower extremities or trunk will receive unilateral treatment with deoxycholate (less than or equal to 2mg/cm2) to assess for safety and proof of concept; this includes participants who have less than or equal to 10-cm2 area of grade I, II, or III cellulite (based on the Nurnberger \& Muller grading scale), and / or post-surgical deformities associated with liposuction.
- Participants will receive less than or equal to 2mg/cm2 deoxycholate in this study. This dose has been shown in previous large scale clinical trials evaluating deoxycholate injections to the submental fat to be a safe and effective dose for treatment with minimal side effects.
- Injections will be 1.0cm apart, 0.2mL/injection into the fatty deformity zone.
- Participants may be injected every 4 weeks for up to 2 treatments.
- The participants will be followed closely for 6 months after the last treatment session to assess the safety and efficacy of deoxycholate. Follow up visits are conducted at Day 7, 14, 28, 35, 42, 56, 84, 112, 140, 168, and 196.
- If the pilot participants show any improvement (1-point improvement on the Nurnberger Muller Lipocytic Deformities grading scale or a 20% improvement on the linear analog scale) in their fatty deformity within the first 2 months after receiving the initial deoxycholate treatment, the investigator will continue with the split-body, placebo-controlled portion of the study (study part 2). Please note that participants enrolled in the pilot study may also be eligible for enrollment in the placebo-controlled study if the participant has more than 2 other fatty deformities.
Part 2, single-center, prospective, double blind, split body study:
- 60 participants (either male or female participants 18 years of age or older) with lipocytic deformities of the lower extremities or trunk will receive injections with deoxycholate and placebo. Participants must have at least two lipocytic deformities that are of a similar nature, and less than or equal to 10cm2 in surface area. This includes participants with grade I, II, or III cellulite (on the Nurnberger Muller Scale) and/or post surgical deformities associated with liposuction.
- These two or more sites will be labeled numerically and blinded, and participants will be randomized to receive injections of deoxycholate (site # 1), and placebo (site # 2) or vice versa to lipocytic deformity zones.
- Participants will receive no more than 10 mL in any treatment session and will not undergo more than 5 treatments. Participants may be injected every 4 weeks for up to 5 treatments.
- All participants will undergo treatment as follows:
- Placebo: 0.2mL / injection to a zone of lipocytic deformity, approximately 1.0cm apart. Patients may be injected every 4 weeks for up to 5 treatments; no participant will receive more than 10 mL in any treatment session
- Deoxycholate (2mg/cm2): 0.2mL / injection to a zone of lipocytic deformity, approximately 1.0cm apart. Participants may be injected every 4 weeks for up to 5 treatments; no participant will receive more than 10 mL in any treatment session
- Study duration: 6 months with 11 Visits
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In the pilot portion of this study, 10 participants will receive treatment with deoxycholate into the zone of lipocytic deformity. In part two of this study, 60 participants with at least two lipocytic deformities will receive injections with deoxycholate into one zone of lipocytic deformity and placebo into the other zone of lipocytic deformity.
| Arm | Type | Receives |
|---|---|---|
| All Subjects Enrolled | Experimental | Drug: KybellaEach subject receives both active intervention (Kybella) and placebo treatment in this arm. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with Grade I, II, or III cellulite (based on the Nurnberger \& Muller Scale) by physician assessment, affecting less than or equal to 10 cm2 surface area, and / or the presence of post surgical deformities associated with liposuction.
- Males and nonpregnant, nonlactating females 18 to 55 years of age, inclusive, on the day of randomization (Visit 1). Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before Visit 1 and agree to practice adequate contraception, in the judgment of the investigator, during the course of the study. Females of childbearing potential who are not sexually active need not practice contraception.
- Time and ability to complete the study and comply with instructions.
- Understanding of the study and contents of the informed consent.
- History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization.
Key exclusion criteria (17 listed)
- Patients who present with adipose tumors (lipoma)
- Human immunodeficiency virus (HIV)- or medication-related lipodystrophies
- Concurrent therapy that, in the investigator's opinion, would interfere with evaluation of the efficacy or safety of the medication.
- Active infection involving the fatty deformity zones.
- Pregnant women, nursing mothers, or women who are planning pregnancy during the study, or think they may be pregnant at the start of the study. Throughout the course of the study, women of childbearing potential must use reliable forms of contraception (e.g. abstinence, oral contraceptives for more than 12 consecutive weeks prior to enrollment, or spermicide and condoms).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KybellaAlso: Deoxycholate, Sodium deoxycholateLess 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. | Drug | All Subjects Enrolled |
Primary outcome
Clinician-Reported Cellulite Grading Scale (CR-CGS) - Assessing Change in Appearance of Lipocytic Deformity
Time frame: Will be measured every 30 days up to 7 months.
Grading performed by investigator using the 4-point Nürnberger and Müller Lipocytic Deformities Grading Scale, assessing the appearance of the zone of lipocytic deformity.
Patient-Reported Visual Analog Scale - Assessing Change in Appearance of Lipocytic Deformity
Time frame: Will be measured every 30 days up to 7 months.
Grading performed by subject using the 10-point Visual Analog Grading Scale, assessing the appearance of the zone of lipocytic deformity.
1 secondary outcome
Subject Global Questions
Time frame: Up to 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corey S Maas, M.D. principal investigator
The Maas Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kybella in people with Deformity; Skin and Fat Redistribution, run by The Maas Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Reported Cellulite Grading Scale (CR-CGS) - Assessing Change in Appearance of Lipocytic Deformity (time frame: Will be measured every 30 days up to 7 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.