Moderate or Severe Submental FullnessPhase 3NCT01426373
Open-Label Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area
A Phase 3 study testing Deoxycholic acid injection in people with Moderate or Severe Submental Fullness, run by Kythera Biopharmaceuticals at 18 sites in United States.
Trial summary
To evaluate the safety of deoxycholic acid subcutaneous injections in the submental area (below the chin). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy 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?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 18 sitesUnited States
- Study dates
- Aug 2011to Jun 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Submental fat graded by the investigator as 2, 3, or 4 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2, 3, or 4 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on visit 1 (within 28 days before the subject's first dosing session)
- Dissatisfaction with the submental area rated by the subject as 0, 1, or 2 using the Subject Self-rating Scale (SSRS) as determined on visit 1 (within 28 days before the subject's first dosing session)
- Males and nonpregnant, nonlactating females 18 years of age or greater, on the day of the subject's first dosing session (visit 2). Females of childbearing potential must have a negative human chorionic gonadotropin (serum) test result within 28 days before visit 2 and agree to practice adequate contraception, in the judgment of the investigator, during the course of the study
- A normal result on coagulation tests (prothrombin time (PT), partial thromboplastin time (PTT)) obtained within 28 days before subject's first dosing session
- History of stable body weight, in the judgment of the investigator, for at least 6 months before subject's first dosing session
- Expected to understand and 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
- Medically able to undergo the administration of study drug determined by clinical and laboratory tests obtained within 28 days before subject's first dosing session for which the investigator identifies 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 (eg, liposuction, surgery, or lipolytic agents)
- History of trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
- A grade of 4 on the Submental Skin Laxity Grading scale (SMSLG) or any other anatomical feature (eg, predominant subplatysmal fat, loose skin in the neck or chin area, prominent platysmal bands) for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome
- Evidence of any cause of enlargement in the submental area (eg, thyroid enlargement, cervical adenopathy) other than localized submental fat
- Body mass index of ≥ 40 kg/m² as determined on visit 1 (week 0)
- History or current symptoms of dysphagia
Show all 11Show fewer
- Any medical condition 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, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before the first treatment session, or botulinum toxin injections in the neck or chin area within 6 months before the first treatment session
- History of sensitivity to any components of the study drug or to topical or local anesthetics (eg, lidocaine, benzocaine, novocaine)
- Previous treatment in this study or previous participation in a Kythera-sponsored ATX-101 study
- Treatment with an investigational device or agent within 30 days before the subject's first treatment session
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Mark Rubin
Beverly Hills, California, 90212
Susan Weinkle
Bradenton, Florida, 34209
Sue Ellen Cox
Chapel Hill, North Carolina, 27517
Steven Dayan
Chicago, Illinois, 60611
David Goldberg, MD
Hillsborough, New Jersey, 08844
Suzanne Bruce
Houston, Texas, 77056
Mitchel Goldman
La Jolla, California, 92121
Michael Gold
Nashville, Tennessee, 37215
Lupo Center for Aesthetic and General Dermatology
New Orleans, Louisiana, 70124
Roy Geronemus, MD
New York, New York, 10016
Macrene Alexiades-Armenakas
New York, New York, 10028
Jeffrey Adelglass
Plano, Texas, 75093
Jeffrey Klein
San Juan Capistrano, California, 92675
Ava Shamban
Santa Monica, California, 90404
Steven Teitelbaum
Santa Monica, California, 90404
Grekin Skin Institute
Warren, Michigan, 48088
Palm Beach Cosmetic
West Palm Beach, Florida, 33401
Richard Fried
Yardley, Pennsylvania, 19067
About this study
Official title: Multicenter, Open-label Study of ATX-101 (Sodium Deoxycholate Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area
To evaluate the safety of deoxycholic acid subcutaneous injections in the submental area (below the chin).
- Conditions
- Moderate or Severe Submental Fullness
- Being tested
- Deoxycholic acid injection
- 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
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
| Study group | Role | What they receive |
|---|---|---|
| Deoxycholic Acid 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.
Number of Participants With Adverse Events (AEs)
Serious AEs include any event that met one or more of the following criteria: was fatal or life-threatening, required inpatient hospitalization or prolonged a hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or a significant medical hazard.
The severity of each AE was defined as either:
Mild: The participant was aware of the sign or symptom, but it was easily tolerated.
Moderate: The sign or symptom caused discomfort and interfered with usual activity.
Severe: The sign or symptom was incapacitating, and the participant was unable to engage in usual activity.
The investigator determined the relationship of each AE to the study drug using the question: "Is there a reasonable possibility that the event may have been caused by treatment with the study drug?"
Measured: Up to 12 months after last treatment (maximum of 18 months from first treatment)
Secondary outcomes (11)
Mean Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (CR-SMFRS)
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 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme). A negative change from baseline indicates improvement.
Measured: Baseline and months 3, 6, 9, and 12 after last treatment
Mean 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?" and answered on a 5-point ordinal scale (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 month 3 and month 12 after last treatment
Percentage of Participants Who Achieved a Composite 1-grade Response
A composite 1-grade response is defined as at least a 1-grade improvement from baseline on both the CR-SMFRS and PR-SMFRS.
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 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme).
The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" and answered on a 5-point ordinal scale (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).
Measured: Baseline and month 3 and month 12 after last treatment
Percentage of Participants Who Achieved a Composite 2-grade Response
A composite 2-grade response is defined as at least a 2-grade improvement from baseline on both the CR-SMFRS and PR-SMFRS.
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 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme).
The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" and answered on a 5-point ordinal scale (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).
Measured: Baseline and month 3 and month 12 after last treatment
Mean 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 (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) 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. 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 month 3 and month 12 after last treatment
Mean Change From Baseline in Subject Self Rating Scale (SSRS)
The SSRS assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 (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 month 3 and month 12 after last treatment
Mean Change From Baseline in Self-rating of Attractiveness
Self-rating of Attractiveness assesses aspects of appearance from the participant's perspective with 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 (1 = not at all attractive, 5 = neither attractive nor unattractive, and 9 = extremely attractive). A positive change from baseline indicates improvement.
Measured: Baseline and month 3 and month 12 after last treatment
Response to Subject Global Questions
Participants answered 3 questions on a 7-point scale that ranged from "a great deal worse" to "a great deal better" (questions 1 and 2) or from "extremely dissatisfied" to "extremely satisfied" (question 3).
Question 1: Since the start of the study, how would you rate the fat under your chin right now?
Question 2: Since the start of the study, how would you rate the definition between your chin and neck right now?
Question 3: How satisfied are you with the treatment you received in this study?
Measured: Month 3 and month 12 after last treatment
Percent Change From Baseline in Submental Fat Thickness
Submental fat thickness was measured using calipers.
Measured: Baseline and month 3 and month 12 after last treatment
Change From Baseline in Submental Skin Laxity Grade (SMSLG)
SMSLG assessment was based on clinical evaluation and palpation of the submental area. The SMSLG scale incorporates 3 features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds).
Grade 1 (none): no or minimal superficial wrinkling, skin well apposed to deeper neck structures, no skin redundancy (no skin draping (vertical folds) or skin sagging (horizontal folds));
Grade 2 (mild): mild superficial wrinkling, skin well apposed to deeper neck structures, minimal skin redundancy (slight skin draping and sagging);
Grade 3 (moderate): may have mild to moderate superficial wrinkling, skin has mild to moderate separation from deeper neck structures, moderate skin redundancy (moderate skin draping and skin sagging);
Grade 4 (severe): mild to marked superficial wrinkling, loose skin separated from deeper neck structures, marked skin redundancy (marked skin draping and sagging).
Measured: Baseline and month 3 and month 12 after last treatment
Change From Baseline in Line Drawing Assessment
Each participant was given 2 example line drawings representing each of the 5 submental fat grades (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme) and asked to select the drawing that best represents their current profile. Improvement is any decrease in grade, and worsening is any increase in grade.
Measured: Baseline and month 3 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 posted31 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2013
- Study completionJun 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kythera Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederick Beddingfield, III, M.D., PhD, Study director, Kythera Biopharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426373
- Sponsor's protocol ID
- ATX-101-11-26
- Status last verified
- Dec 2015
- First submitted
- 26 Aug 2011
- Last updated
- 14 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Beer K, Weinkle SH, Cox SE, Rubin MG, Shamban A, Somogyif C. ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat: Results From a 12-Month Open-Label Study. J Drugs Dermatol. 2019 Sep 1;18(9):870-877.
PubMed 31524342
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label Study of ATX-101 (Sodium Deoxycholate Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area
- ClinicalTrials.gov ID
- NCT01426373
- Acronym / sponsor ID
- ATX-101-11-26
- Conditions
- Moderate or Severe Submental Fullness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 31 Aug 2011 (estimated)
- Results
- Posted 14 Jan 2016
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 of deoxycholic acid subcutaneous injections in the submental area (below the chin).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deoxycholic Acid 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 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Submental fat graded by the investigator as 2, 3, or 4 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2, 3, or 4 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on visit 1 (within 28 days before the subject's first dosing session)
- Dissatisfaction with the submental area rated by the subject as 0, 1, or 2 using the Subject Self-rating Scale (SSRS) as determined on visit 1 (within 28 days before the subject's first dosing session)
- Males and nonpregnant, nonlactating females 18 years of age or greater, on the day of the subject's first dosing session (visit 2). Females of childbearing potential must have a negative human chorionic gonadotropin (serum) test result within 28 days before visit 2 and agree to practice adequate contraception, in the judgment of the investigator, during the course of the study
- A normal result on coagulation tests (prothrombin time (PT), partial thromboplastin time (PTT)) obtained within 28 days before subject's first dosing session
- History of stable body weight, in the judgment of the investigator, for at least 6 months before subject's first dosing session
Key exclusion criteria (11 listed)
- History of any intervention to treat submental fat (eg, liposuction, surgery, or lipolytic agents)
- History of trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
- A grade of 4 on the Submental Skin Laxity Grading scale (SMSLG) or any other anatomical feature (eg, predominant subplatysmal fat, loose skin in the neck or chin area, prominent platysmal bands) for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome
- Evidence of any cause of enlargement in the submental area (eg, thyroid enlargement, cervical adenopathy) other than localized submental fat
- Body mass index of ≥ 40 kg/m² as determined on visit 1 (week 0)
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, KybellaFormulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL. | Drug | Deoxycholic Acid 2 mg/cm² |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Up to 12 months after last treatment (maximum of 18 months from first treatment)
Serious AEs include any event that met one or more of the following criteria: was fatal or life-threatening, required inpatient hospitalization or prolonged a hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or a significant medical hazard. The severity of each AE was defined as either: Mild: The participant was aware of the sign or symptom, but it was easily tolerated. Moderate: The sign or symptom caused discomfort and interfered with usual activity. Severe: The sign or symptom was incapacitating, and the participant was unable to engage in usual activity. The investigator determined the relationship of each AE to the study drug using the question: "Is there a reasonable possibility that the event may have been caused by treatment with the study drug?"
11 secondary outcomes
Mean Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (CR-SMFRS)
Time frame: Baseline and months 3, 6, 9, and 12 after last treatment
Mean Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)
Time frame: Baseline and month 3 and month 12 after last treatment
Percentage of Participants Who Achieved a Composite 1-grade Response
Time frame: Baseline and month 3 and month 12 after last treatment
Percentage of Participants Who Achieved a Composite 2-grade Response
Time frame: Baseline and month 3 and month 12 after last treatment
Mean Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
Time frame: Baseline and month 3 and month 12 after last treatment
Mean Change From Baseline in Subject Self Rating Scale (SSRS)
Time frame: Baseline and month 3 and month 12 after last treatment
Mean Change From Baseline in Self-rating of Attractiveness
Time frame: Baseline and month 3 and month 12 after last treatment
Response to Subject Global Questions
Time frame: Month 3 and month 12 after last treatment
Percent Change From Baseline in Submental Fat Thickness
Time frame: Baseline and month 3 and month 12 after last treatment
Change From Baseline in Submental Skin Laxity Grade (SMSLG)
Time frame: Baseline and month 3 and month 12 after last treatment
Change From Baseline in Line Drawing Assessment
Time frame: Baseline and month 3 after last treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31524342Beer K, Weinkle SH, Cox SE, Rubin MG, Shamban A, Somogyif C. ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat: Results From a 12-Month Open-Label Study. J Drugs Dermatol. 2019 Sep 1;18(9):870-877.
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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, III, M.D., PhD study director
Kythera Biopharmaceuticals, Inc
18 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 Deoxycholic acid injection in people with Moderate or Severe Submental Fullness, run by Kythera Biopharmaceuticals at 18 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 8 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 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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. 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 14 Jan 2016). 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?
Number of Participants With Adverse Events (AEs) (time frame: Up to 12 months after last treatment (maximum of 18 months from first treatment)). 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 NCT01426373, 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 Jan 2016.