Moderate or Severe Submental FullnessPhase 2NCT01032889
Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study
A Phase 2 study testing Deoxycholic acid injection in people with Moderate or Severe Submental Fullness, run by Kythera Biopharmaceuticals at 10 sites in United States.
Trial summary
Evaluation of the safety, tolerability 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
- 129 participants
- Where
- 10 sitesUnited States
- Study dates
- Dec 2009to Dec 2010
- Phase
- Phase 2
- 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
- Moderate or severe submental fat
- Dissatisfaction with submental area
- History of stable body weight
- Signed informed consent
Who cannot join
- Any medical or other condition that would affect subject safety or evaluation of efficacy
- Previous intervention in the submental area
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Investigational Site
Beverly Hills, California, 90210
Investigational Site
Beverly Hills, California, 90212
Investigational Site
Birmingham, Alabama, 35205
Investigational Site
Chestnut Hill, Massachusetts, 02467
Investigational Site
Fridley, Minnesota, 55432
Investigational Site
Naperville, Illinois, 60563
Investigational Site
Omaha, Nebraska, 68144
Investigational Site
Plano, Texas, 75093
Investigational Site
San Francisco, California, 94115
Investigational Site
St Louis, Missouri, 63141
About this study
Official title: 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 (SMF) Using Magnetic Resonance Imaging (MRI) and a Battery of Clinician- and Subject-reported Measurements.
Evaluation of the safety, tolerability 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, Kybella
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 6 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 6 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 6 treatments. Receives: Drug: Deoxycholic acid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Clinician-Reported Submental Fat Rating Scale 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 32 weeks after first treatment)
Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)
The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" 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. A negative change from Baseline indicates improvement.
Measured: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
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 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.
Measured: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Secondary outcomes (2)
Change From Baseline in Submental Fat Volume
Submental fat volume was measured by magnetic resonance imaging (MRI).
Measured: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Change From Baseline in Submental Fat Thickness
Submental fat thickness was measured by magnetic resonance imaging (MRI).
Measured: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionDec 2010
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kythera Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederick Beddingfield, MD, PhD, Study director, Kythera Biopharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032889
- Sponsor's protocol ID
- ATX-101-09-15
- Status last verified
- May 2015
- First submitted
- 10 Dec 2009
- Last updated
- 15 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 (SMF) Using Magnetic Resonance Imaging (MRI) and a Battery of Clinician- and Subject-reported Measurements.
- ClinicalTrials.gov ID
- NCT01032889
- Acronym / sponsor ID
- ATX-101-09-15
- Conditions
- Moderate or Severe Submental Fullness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Dec 2009 (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.
Evaluation of the safety, tolerability 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 6 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 6 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 6 treatments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate or severe submental fat
- Dissatisfaction with submental area
- History of stable body weight
- Signed informed consent
Key exclusion criteria (2 listed)
- Any medical or other condition that would affect subject safety or evaluation of efficacy
- Previous intervention in the submental area
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, Kybella | Drug | Deoxycholic acid Injection 1 mg/cm², Deoxycholic acid Injection 2 mg/cm² |
| PlaceboPhosphate buffered saline placebo for injection | Drug | Placebo |
Primary outcome
Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores
Time frame: Baseline and 12 weeks after last treatment (up to 32 weeks after first 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. A negative change from Baseline indicates improvement.
Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)
Time frame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" 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. A negative change from Baseline indicates improvement.
Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
Time frame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.
2 secondary outcomes
Change From Baseline in Submental Fat Volume
Time frame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Change From Baseline in Submental Fat Thickness
Time frame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Moderate or Severe Submental Fullness
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A Phase I Study of HY-2003 in the Subjects With Excessive Submental Fat Accumulation
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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deoxycholic acid injection in people with Moderate or Severe Submental Fullness, run by Kythera Biopharmaceuticals at 10 sites 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 4 inclusion and 2 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 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (time frame: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)). The study lists 3 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 15 Jun 2015.