Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis

Allergan145 enrolled

Overview

The purpose of this study is to establish the therapeutic range of ANT-1207 in the treatment of primary axillary hyperhidrosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

145

Conditions

Hyperhidrosis

Interventions

VehicleBIOLOGICAL

Vehicle for ANT-1207 liniment formulation without active ingredient.

ANT-1207BIOLOGICAL

Botulinum toxin Type A topical liniment (ANT-1207).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ages 18 - 70 years of age * diagnosis of primary axillary hyperhidrosis * HDSS score of ≥3 * threshold sweat production/axilla in 5 minutes as measured gravimetrically * willingness to shave underarms prior to each study visit Exclusion Criteria: * botulinum toxin treatment in the prior 6 months * signs of infection in the axilla * skin affliction in the axilla requiring medical treatment * oral anticholinergic treatment * use of antiperspirants, deodorants, powders, or lotions * use of axillary depilatories or axillary epilation * history of surgery or other interventions for axillary hyperhidrosis * female subjects who are pregnant or are nursing a child

Locations (19)

San Marcus Research Clinic, Inc.

Hialeah, Florida, United States

Baumann Cosmetic & Research Institute

Outcomes

Primary Outcomes

Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50%

The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities. GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. The HDSS and the GSP were assessed at Baseline and Week 12. The change from Baseline was calculated. The percentage of participants who had both a change (reduction) from Baseline in HDSS score by ≥ 2 points and a change (reduction) from Baseline in GSP by ≥ 50% is reported.

Time frame: Baseline, Week 12

Secondary Outcomes

Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points

Time frame: Baseline, Weeks 4, 8, 12 and 18

Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50%

GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in GSP by ≥ 50% is reported.

Time frame: Baseline, Weeks 4, 8, 12 and 18

Data from ClinicalTrials.gov

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