CompletedPhase 3

Patient Experience Study of Deoxycholic Acid Injection

United States84 participantsStarted 2013-12

Plain-language summary

The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema.

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

✓. Submental fat graded by the Investigator as 2 (moderate) or 3 (severe) using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 (moderate amount) or 3 (large amount) using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
✓. Dissatisfaction with the appearance of the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS)
✓. History of stable body weight for at least 6 months and body mass index (BMI) of ≤ 40 kg/m².
✓. Acceptable skin laxity as determined by the investigator
✓. Agreement by the subject to refrain from making significant changes, in the documented judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation.
✓. Agreement to forego any treatment or behavior (e.g., unshaven facial hair)
✓. Signed informed consent obtained before any study-specific procedure is performed.

Exclusion criteria

✕. No prior intervention for submental fullness or recent cosmetic procedure in the neck or chin area
✕. Absence of clinically significant health problems
✕. Body mass index \> 40.0 kg/m² as determined prior to randomization.
✕. History of drug or alcohol abuse.

What they're measuring

Change From Baseline in Pain Visual Analog Scale Scores

Timeframe: Baseline and Day 84

Change From Baseline in Pain Assessment Using McGill Pain Questionnaire

Timeframe: Baseline (predose) and Day 84

Swelling Grading Scale Scores

Timeframe: Day 84

Bruising Grading Scale Scores

Timeframe: Day 84

Induration Grading Scale Scores

Timeframe: Day 84

Trial details

NCT IDNCT02007434

SponsorKythera Biopharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-06

Results submitted2015-06-12

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

Plain-language summary

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

✓. Submental fat graded by the Investigator as 2 (moderate) or 3 (severe) using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 (moderate amount) or 3 (large amount) using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
✓. Dissatisfaction with the appearance of the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS)
✓. History of stable body weight for at least 6 months and body mass index (BMI) of ≤ 40 kg/m².
✓. Acceptable skin laxity as determined by the investigator
✓. Agreement by the subject to refrain from making significant changes, in the documented judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation.
✓. Agreement to forego any treatment or behavior (e.g., unshaven facial hair)
✓. Signed informed consent obtained before any study-specific procedure is performed.

Exclusion criteria

✕. No prior intervention for submental fullness or recent cosmetic procedure in the neck or chin area
✕. Absence of clinically significant health problems
✕. Body mass index \> 40.0 kg/m² as determined prior to randomization.
✕. History of drug or alcohol abuse.

What they're measuring

Change From Baseline in Pain Visual Analog Scale Scores

Timeframe: Baseline and Day 84

Change From Baseline in Pain Assessment Using McGill Pain Questionnaire

Timeframe: Baseline (predose) and Day 84

Swelling Grading Scale Scores

Timeframe: Day 84

Bruising Grading Scale Scores

Timeframe: Day 84

Induration Grading Scale Scores

Timeframe: Day 84