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Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035267
Recruitment Status : Completed
First Posted : January 14, 2014
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Kythera Biopharmaceuticals

Brief 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 in patients with mild or extreme fullness of the submental fat and ratings of 1 or 4.

Condition or disease Intervention/treatment Phase
Moderate to Severe Convexity of Submental Fat Safety Efficacy Drug: Deoxycholic Acid Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 With Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Grade 1 or CR-SMFRS Grade 4
Study Start Date : January 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo - Grade 1
Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With CR SMFRS Grade 1 (mild).
Drug: Placebo
Phosphate buffered saline placebo for injection.

Experimental: ATX-101 deoxycholic acid injection - Grade 1
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. Participants With Clinician-Reported Submental Fat Rating Scale (CR SMFRS) Grade 1 (mild).
Drug: Deoxycholic Acid
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Other Name: ATX-101 deoxycholic acid injection

Placebo Comparator: Placebo - Grade 4
Participants received placebo 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. Participants With CR SMFRS Grade 4 (extreme).
Drug: Placebo
Phosphate buffered saline placebo for injection.

Experimental: ATX-101 deoxycholic acid injection - Grade 4
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. Participants with CR SMFRS Grade 4 (extreme).
Drug: Deoxycholic Acid
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Other Name: ATX-101 deoxycholic acid injection




Primary Outcome Measures :
  1. 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).


  2. 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).


  3. 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).

  4. 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).

  5. Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on 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).

  6. Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on 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).

  7. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subjects, 18 to 65 years old
  • Stable Body weight
  • Body Mass Index (BMI) of ≤40.0 kg/m^2
  • Acceptable volume of submental fat graded by clinician
  • Dissatisfaction with the submental area expressed by the subject
  • Signed informed consent form (ICF)
  • SMF ratings of 1 or 4

Exclusion Criteria:

  • No prior intervention for submental fat (SMF) (eg, liposuction, surgery, or lipolytic agents)
  • Presence of clinically significant health problems
  • History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
  • Body mass index ≤40 kg/m^2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035267


Locations
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United States, California
Newport Beach, California, United States
San Francisco, California, United States
West Hollywood, California, United States, 90069
United States, Florida
Boca Raton, Florida, United States
Coral Gables, Florida, United States, 33146
United States, Maryland
Glenn Dale, Maryland, United States, 20769
United States, Massachusetts
Chestnut Hill, Massachusetts, United States, 02467
United States, Missouri
Saint Louis, Missouri, United States
Sponsors and Collaborators
Kythera Biopharmaceuticals
Investigators
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Study Director: Frederick Beddingfield, III, MD, PhD Sponsor GmbH
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Responsible Party: Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT02035267    
Other Study ID Numbers: ATX-101-13-27
First Posted: January 14, 2014    Key Record Dates
Results First Posted: February 17, 2020
Last Update Posted: February 17, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Deoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents