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

Phase 2

Completed

• Conditions: Hyperhidrosis

• Registration Number: NCT02479139
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-03
• Study First Submitted: 2015-06-19
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-24
• Primary Completion: 2016-02-29
• Study Completion: 2016-02-29
• Status Verified: 2017-08
• Results First Submitted: 2017-08-25
• Results First Submitted QC: 2017-08-25
• Last Update Submitted: 2017-08-25
• Results First Posted: 2017-09-20
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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%	Baseline, Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points	Baseline, Weeks 4, 8, 12 and 18	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.; The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in HDSS score by ≥ 2 points is reported.
Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50%	Baseline, Weeks 4, 8, 12 and 18	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.

Trial Locations

Locations (19)

San Marcus Research Clinic, Inc.; 🇺🇸 Hialeah, Florida, United States

Baumann Cosmetic & Research Institute; 🇺🇸 Miami, Florida, United States

Radiant Research, Inc.; 🇺🇸 Pinellas Park, Florida, United States

Research Institute of the Southeast, LLC; 🇺🇸 West Palm Beach, Florida, United States

Shideler Clinical Research Center; 🇺🇸 Carmel, Indiana, United States

William Coleman III, MD, APMC; 🇺🇸 Metairie, Louisiana, United States

Lupo Center for Aesthetic & General Dermatology; 🇺🇸 New Orleans, Louisiana, United States

Skin Specialists, PC; 🇺🇸 Omaha, Nebraska, United States

JUVA Skin and Laser Center; 🇺🇸 New York, New York, United States

Skin Search of Rochester, Inc.; 🇺🇸 Rochester, New York, United States

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