Phase 1-2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and potential efficacy of deoxycholic acid injection compared to placebo for the reduction of submental fat (fat below the chin).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kythera Biopharmaceuticals
• Treatments: Deoxycholic Acid

Criteria

Inclusion Criteria:

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