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

Hyperhidrosis Clinical Trial

Official title:

Clinical Trial to Evaluate ANT-1207 in the Treatment of Primary Axillary Hyperhidrosis in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479139
• Other study ID #: ANT-1207-HHID-205
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2015
• Last updated: August 25, 2017
• Start date: June 3, 2015
• Est. completion date: February 29, 2016

Study information

• Verified date: August 2017
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: February 29, 2016
• Est. primary completion date: February 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Biological:
• Vehicle
Vehicle for ANT-1207 liniment formulation without active ingredient.
• ANT-1207
Botulinum toxin Type A topical liniment (ANT-1207).

Locations

Country	Name	City	State
United States	Westlake Dermatology Clinical Research Center	Austin	Texas
United States	Shideler Clinical Research Center	Carmel	Indiana
United States	PMG Research of Cary	Cary	North Carolina
United States	Dermatology and Laser Center of Charleston, PA	Charleston	South Carolina
United States	J&S Studies, Inc.	College Station	Texas
United States	San Marcus Research Clinic, Inc.	Hialeah	Florida
United States	Allus Clinical Research	Jenkintown	Pennsylvania
United States	The Skin Wellness Center	Knoxville	Tennessee
United States	William Coleman III, MD, APMC	Metairie	Louisiana
United States	Baumann Cosmetic & Research Institute	Miami	Florida
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Lupo Center for Aesthetic & General Dermatology	New Orleans	Louisiana
United States	JUVA Skin and Laser Center	New York	New York
United States	Virginia Clinical Research Inc.	Norfolk	Virginia
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Radiant Research, Inc.	Pinellas Park	Florida
United States	Skin Search of Rochester, Inc.	Rochester	New York
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	Research Institute of the Southeast, LLC	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 12
Secondary	Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline = 2 Points	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.	Baseline, Weeks 4, 8, 12 and 18
Secondary	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.	Baseline, Weeks 4, 8, 12 and 18