Moderate to Severe Convexity of Submental FatPhase 3NCT02123134
Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age
A Phase 3 study testing ATX-101 in people with Moderate to Severe Convexity of Submental Fat and Safety, run by Kythera Biopharmaceuticals at 6 sites in United States.
Trial summary
The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area of participants who are 65 to 75 years old. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate to Severe Convexity of Submental Fat, Safety, Efficacy
- What is being tested?
- ATX-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2014to Sep 2015
- 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 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Males and females, 65 to 75 years of age
- Stable Body Weight
- Dissatisfaction with the submental area expressed by participants
- Acceptable volume of submental fat graded by clinician
- BMI of ≤40.0 kg/m^2
- Signed informed consent (ICF)
- SMF rating of 2 or 3 by clinician and patient
Who cannot join
- No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic agents)
- Absence of clinically significant health problems
- Anatomical features for which reduction in SMF may result in aesthetically unacceptable outcome, judged by clinician
- History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy
- Body mass index of ≥40.0 kg/m^2
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Birmingham, Alabama, 35205
Study site
Bradenton, Florida, 34209
Study site
Cincinnati, Ohio, 45255
Study site
Los Angeles, California, 90036
Study site
Metairie, Louisiana, 70006
Study site
White Plains, New York, 10604
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled Safety Study of ATX-101 (Deoxycholic Acid) Injection for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age
The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area of participants who are 65 to 75 years old.
- Being tested
- ATX-101, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATX-101Drug
Also called deoxycholic acid
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
PlaceboDrug
Phosphate buffered saline placebo for injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Receives: Drug: Placebo |
| ATX-101 deoxycholic acid injection | Experimental | Participants received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Receives: Drug: ATX-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Measured: Baseline and up to Week 32 (12 weeks after last treatment)
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Measured: Baseline and up to Week 32 (12 weeks after last treatment)
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
Measured: Baseline and up to Week 32 (12 weeks after last treatment)
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
Measured: Baseline and up to Week 32 (12 weeks after last treatment)
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Measured: Baseline and up to Week 32 (12 weeks after last treatment)
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Measured: Baseline and up to Week 32 (12 weeks after last treatment)
Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG)
The SMSLG is an integration of three features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Each grade (1=none, 2=mild, 3=moderate and 4=severe) defines the maximal allowed limit for skin wrinkling, adherence to underlying structures and redundancy.
Measured: Baseline and up to Week 32 (12 weeks after last treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2015
- Study completionSep 2015
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 to Severe Convexity of Submental FatStudies 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kythera Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederick Beddingfield, III, MD, PhD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123134
- Sponsor's protocol ID
- ATX-101-13-28
- Status last verified
- Jan 2020
- First submitted
- 22 Apr 2014
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo-controlled Safety Study of ATX-101 (Deoxycholic Acid) Injection for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age
- ClinicalTrials.gov ID
- NCT02123134
- Acronym / sponsor ID
- ATX-101-13-28
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Posted 17 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area of participants who are 65 to 75 years old.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 milliliters (mL) per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. |
| ATX-101 deoxycholic acid injection | Experimental | Drug: ATX-101Participants received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL SC 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
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Males and females, 65 to 75 years of age
- Stable Body Weight
- Dissatisfaction with the submental area expressed by participants
- Acceptable volume of submental fat graded by clinician
- BMI of ≤40.0 kg/m^2
Key exclusion criteria (5 listed)
- No prior intervention for submental fat (SMF) (eg liposuction, surgery or lipolytic agents)
- Absence of clinically significant health problems
- Anatomical features for which reduction in SMF may result in aesthetically unacceptable outcome, judged by clinician
- History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy
- Body mass index of ≥40.0 kg/m^2
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 |
|---|---|---|
| ATX-101Also: deoxycholic acidFormulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL. | Drug | ATX-101 deoxycholic acid injection |
| PlaceboPhosphate buffered saline placebo for injection | Drug | Placebo |
Primary outcome
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG)
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
The SMSLG is an integration of three features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Each grade (1=none, 2=mild, 3=moderate and 4=severe) defines the maximal allowed limit for skin wrinkling, adherence to underlying structures and redundancy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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, III, MD, PhD study director
Sponsor GmbH
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ATX-101 in people with Moderate to Severe Convexity of Submental Fat and Safety, run by Kythera Biopharmaceuticals at 6 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 7 inclusion and 5 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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 17 Feb 2020). 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 at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments (time frame: Baseline and up to Week 32 (12 weeks after last treatment)). The study lists 7 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 17 Feb 2020.