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

K

Kythera Biopharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Moderate or Severe Submental Fullness

Treatments

Drug: Placebo
Drug: Deoxycholic acid injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT01032889
ATX-101-09-15

Details and patient eligibility

About

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

Enrollment

129 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

129 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Participants received placebo 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.
Treatment:
Drug: Placebo
Deoxycholic acid Injection 1 mg/cm²
Experimental group
Description:
Participants received deoxycholic acid 1 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.
Treatment:
Drug: Deoxycholic acid injection
Deoxycholic acid Injection 2 mg/cm²
Experimental group
Description:
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.
Treatment:
Drug: Deoxycholic acid injection

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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