Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kythera Biopharmaceuticals
• Treatments: Deoxycholic Acid

Criteria

Inclusion Criteria:

• Submental fat that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the submental fat (SMF) rating scale

• Good general health

• Signed informed consent

Exclusion Criteria:

• History of any treatment in the neck or chin area

• Loose skin or prominent platysmal bands in the neck or chin area

• Recent treatment with anticoagulants

• Presence of clinically significant health problems