Moderate or Severe Submental FullnessPhase 3NCT01305577
Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat
A Phase 3 study testing Deoxycholic acid injection in people with Moderate or Severe Submental Fullness, run by Kythera Biopharmaceuticals at 30 sites in 5 countries.
Trial summary
To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate or Severe Submental Fullness
- What is being tested?
- Deoxycholic acid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 363 participants
- Where
- 30 sitesin 5 countries
- Study dates
- Dec 2010to Jan 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) as determined on Visit 2.
- Dissatisfaction with the submental area rated by the subject as 0, 1, 2, or 3 using the Subject Self Rating Scale (SSRS).
- Males and nonpregnant, nonlactating females between 18 and 65 years of age, inclusive on the day of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before randomization and agree to practice medically acceptable birth control during the course of the study. Medically acceptable birth control includes: surgical sterilization, hormonal contraceptives, barrier methods or an intrauterine device (IUD).
- History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization. No significant change, in the judgment of the investigator, in diet or exercise practices for at least 6 months before randomization and agreement to not change diet or exercise practices during the course of the study.
- Expected to comply with and understand the visit schedule and all protocol-specified tests and procedures.
- Medically able to undergo the administration of study material determined by clinical evaluations made within 56 days before 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
- History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents) or trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.
- Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome or a score of 4 on the Skin Laxity Rating Scale (SLRS).
- Prominent platysmal bands at rest or other anatomical features that, in the judgment of the investigator, may interfere with the evaluation of submental fat or result in an aesthetically unacceptable outcome.
- Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat.
- Body mass index (BMI) greater than 30.
- Currently on or considering starting a weight reduction regimen.
Show all 11Show fewer
- Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.
- Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections in the neck or chin area within 6 months before randomization.
- History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, or novocaine).
- Previous randomization into this study or previous treatment with ATX-101.
- Treatment with an investigational device or agent within 30 days of randomization.
Trial locations and contacts
30 sites in 5 countries.
30 sites in 5 countries
Germany12 sites
Investigational Site
Augsburg, 86163
Investigational Site
Augsburg, 86179
Investigational Site
Berlin, 10117
Investigational Site
Darmstadt, 64297
Investigational Site
Frankfurt am Main, 60590
Investigational Site
Landau, 76829
Investigational Site
Ludwigshafen, 67061
Investigational Site
München, 80337
Investigational Site
Northeim, D-37154
Investigational Site
Potsdam, 14469
Investigational Site
Starnberg, 82319
Investigational Site
Wuppertal, 42275
United Kingdom7 sites
Investigational Site
Cheltenham, GL50 1QZ
Investigational Site
London, London, SW1 9QN
Investigational Site
Northampton, Northampton, NN4 7BU
Investigational Site
Nottingham, Nottingham, NG3 7DQ
Investigational Site
Nottingham, Nottingham, NG9 8AR
Investigational Site
Plymouth, Plymouth, PL6 8BX
Investigational Site
Salford, Manchester, M6 8HD
France6 sites
Investigational Site
Arras, 62000
Investigational Site
Cannes, 06400
Investigational Site
Nice, 06202
Investigational Site
Pantin, 93500
Investigational Site
Paris, 75005
Investigational Site
Paris, 75010
Spain4 sites
Investigational Site
Barcelona, 08017
Investigational Site
Barcelona, 08022
Investigational Site
Barcelona, 08028
Investigational Site
Barcelona, 08034
About this study
Official title: Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area
To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
- Conditions
- Moderate or Severe Submental Fullness
- Being tested
- Deoxycholic acid injection, Placebo
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deoxycholic acid injectionDrug
Also called ATX-101
PlaceboDrug
Phosphate buffered saline placebo for injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. Receives: Drug: Placebo |
| Deoxycholic Acid Injection 1 mg/cm² | Experimental | Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. Receives: Drug: Deoxycholic acid injection |
| Deoxycholic Acid Injection 2 mg/cm² | Experimental | Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. Receives: Drug: Deoxycholic acid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response
A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment.
The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
Measured: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Percentage of Participants With a Subject Self Rating Scale (SSRS) Response
A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment.
The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.
Measured: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Secondary outcomes (9)
Percentage of Participants With a CR-SMFRS 2-grade Response
A CR-SMFRS 2-grade response is defined as at least a 2-point improvement (i.e. 2-point reduction) from Baseline 12 weeks after the last treatment.
The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
Measured: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in CR-SMFRS Scores
The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
A negative change from Baseline indicates improvement.
Measured: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in SSRS Scores
The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.
A positive change from Baseline indicates improvement.
Measured: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Submental Fat Thickness
Submental thickness was measured using caliper devices.
Measured: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)
The PR-SMFRS is based on the participant's response to the question "How much fat do you currently have under your chin?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. Improvement is defined as any decrease in score and worsened as any increase in score.
Measured: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
The PR-SMFIS assesses the impact of submental fat on self-perception of 6 characteristics related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10.
Measured: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Self-rating of Attractiveness
Self-rating of attractiveness assesses aspects of appearance from the participant's perspective by a series of 6 questions:
How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are?" Each question was answered on a scale from 1 to 9 where 1 = Not at all attractive, 5 = Neither attractive nor unattractive and 9 = Extremely attractive.
A positive change from Baseline indicates improvement.
Measured: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Derriford Appearance Scale 24 (DAS24)
Measured: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Body Image Quality of Life Inventory (BIQLI)
Measured: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate or Severe Submental FullnessStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kythera Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Frederick Beddingfield, MD, PhD, Study director, Kythera Biopharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305577
- Sponsor's protocol ID
- ATX-101-10-16
- Other IDs
- 2010-020690-17
- Status last verified
- Jun 2015
- First submitted
- 10 Feb 2011
- Last updated
- 14 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McDiarmid J, Ruiz JB, Lee D, Lippert S, Hartisch C, Havlickova B. Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic reduction of excess submental fat. Aesthetic Plast Surg. 2014 Oct;38(5):849-60. doi: 10.1007/s00266-014-0364-9. Epub 2014 Jul 2.
PubMed 24984785
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area
- ClinicalTrials.gov ID
- NCT01305577
- Acronym / sponsor ID
- ATX-101-10-16
- Conditions
- Moderate or Severe Submental Fullness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Dec 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Posted 15 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| Deoxycholic Acid Injection 1 mg/cm² | Experimental | Drug: Deoxycholic acid injectionParticipants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
| Deoxycholic Acid Injection 2 mg/cm² | Experimental | Drug: Deoxycholic acid injectionParticipants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) as determined on Visit 2.
- Dissatisfaction with the submental area rated by the subject as 0, 1, 2, or 3 using the Subject Self Rating Scale (SSRS).
- Males and nonpregnant, nonlactating females between 18 and 65 years of age, inclusive on the day of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before randomization and agree to practice medically acceptable birth control during the course of the study. Medically acceptable birth control includes: surgical sterilization, hormonal contraceptives, barrier methods or an intrauterine device (IUD).
- History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization. No significant change, in the judgment of the investigator, in diet or exercise practices for at least 6 months before randomization and agreement to not change diet or exercise practices during the course of the study.
- Expected to comply with and understand the visit schedule and all protocol-specified tests and procedures.
Key exclusion criteria (11 listed)
- History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents) or trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.
- Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome or a score of 4 on the Skin Laxity Rating Scale (SLRS).
- Prominent platysmal bands at rest or other anatomical features that, in the judgment of the investigator, may interfere with the evaluation of submental fat or result in an aesthetically unacceptable outcome.
- Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat.
- Body mass index (BMI) greater than 30.
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 |
|---|---|---|
| Deoxycholic acid injectionAlso: ATX-101 | Drug | Deoxycholic Acid Injection 1 mg/cm², Deoxycholic Acid Injection 2 mg/cm² |
| PlaceboPhosphate buffered saline placebo for injection | Drug | Placebo |
Primary outcome
Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
Percentage of Participants With a Subject Self Rating Scale (SSRS) Response
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment. The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.
9 secondary outcomes
Percentage of Participants With a CR-SMFRS 2-grade Response
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in CR-SMFRS Scores
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in SSRS Scores
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Submental Fat Thickness
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Self-rating of Attractiveness
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Derriford Appearance Scale 24 (DAS24)
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Change From Baseline in Body Image Quality of Life Inventory (BIQLI)
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24984785McDiarmid J, Ruiz JB, Lee D, Lippert S, Hartisch C, Havlickova B. Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic reduction of excess submental fat. Aesthetic Plast Surg. 2014 Oct;38(5):849-60. doi: 10.1007/s00266-014-0364-9. Epub 2014 Jul 2.
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Moderate or Severe Submental Fullness
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.
Frederick Beddingfield, MD, PhD study director
Kythera Biopharmaceuticals, Inc.
30 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Deoxycholic acid injection in people with Moderate or Severe Submental Fullness, run by Kythera Biopharmaceuticals at 30 sites in 5 countries.
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 7 inclusion and 11 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 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Germany, United Kingdom, France, Spain, Belgium. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response (time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)). 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?
On the ClinicalTrials.gov record for NCT01305577, which also lists 1 linked publication.
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 14 Jul 2015.