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

Anterios

Status and phase: Completed; Phase 2

Conditions: Primary Axillary Hyperhidrosis

Treatments: Biological: ANT-1403; Biological: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01799824

ANT-1403-HHID-202

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

ANT-1403

Treatment:

Biological: ANT-1403

Vehicle

Placebo Comparator group

Description:

Vehicle

Treatment:

Biological: placebo