CompletedPhase 2

Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study

United States129 participantsStarted 2009-12

Plain-language summary

Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Moderate or severe submental fat * Dissatisfaction with submental area * History of stable body weight * Signed informed consent Exclusion Criteria: * Any medical or other condition that would affect subject safety or evaluation of efficacy * Previous intervention in the submental area

What they're measuring

Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores

Timeframe: 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)

Timeframe: 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)

Timeframe: Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)

Trial details

NCT IDNCT01032889

SponsorKythera Biopharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-12

Results submitted2015-05-28

View on ClinicalTrials.gov More Moderate or Severe Submental Fullness trials