Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis

Phase 2

Completed

• Conditions: Primary Axillary Hyperhidrosis
• Interventions: Biological: ANT-1403; Biological: placebo

• Registration Number: NCT01799824
• Lead Sponsor: Anterios Inc.

Brief Summary

The purpose of this study is to confirm the effect of ANT-1403 in the treatment of primary axillary hyperhidrosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-27
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-11
• Disposition First Submitted: 2013-11-15
• Disposition First Submitted QC: 2013-11-15
• Last Update Submitted: 2013-11-15
• Disposition First Posted: 2013-12-10
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• ages 18 - 70 years of age
• diagnosis of moderate to severe primary axillary hyperhidrosis
• ≥50 mg of sweat production/axilla in 5 minutes as measured gravimetrically
• HDSS score of ≥3

Exclusion Criteria

• diagnosis of secondary hyperhidrosis
• skin affliction in the axilla requiring medical treatment
• 20% aluminum hydrochloride, e.g. Drysol®, in 2 weeks prior of Baseline
• oral anticholinergic treatment
• botulinum toxin treatment in the prior 9 months
• history of surgery for axillary hyperhidrosis
• present or history of neuromuscular disease
• female subjects who are pregnant or are nursing a child

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	ANT-1403	ANT-1403
Vehicle	placebo	Vehicle

Primary Outcome Measures

Name	Time	Method
HDSS	Week 8

Secondary Outcome Measures

Name	Time	Method
GSP	Week 8