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

NCT02479139 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ANT-1207-HHID-205
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Baseline, Weeks 4, 8, 12 and 18

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

  Baseline, Weeks 4, 8, 12 and 18

Study Arms (6)

Vehicle

PLACEBO COMPARATOR

Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.

Biological: Vehicle

ANT-1207 Dose 1

EXPERIMENTAL

Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.

Biological: ANT-1207

ANT-1207 Dose 2

EXPERIMENTAL

Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.

Biological: ANT-1207

ANT-1207 Dose 3

EXPERIMENTAL

Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.

Biological: ANT-1207

ANT-1207 Dose 4

EXPERIMENTAL

Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.

Biological: ANT-1207

ANT-1207 Dose 5

EXPERIMENTAL

Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.

Biological: ANT-1207

Interventions

Vehicle BIOLOGICAL

Vehicle for ANT-1207 liniment formulation without active ingredient.

Vehicle

ANT-1207 BIOLOGICAL

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

ANT-1207 Dose 1; ANT-1207 Dose 2; ANT-1207 Dose 3; ANT-1207 Dose 4; ANT-1207 Dose 5

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (19)

San Marcus Research Clinic, Inc.

Hialeah, Florida, 33015, United States

Location

Baumann Cosmetic & Research Institute

Miami, Florida, 33137, United States

Location

Radiant Research, Inc.

Pinellas Park, Florida, 33781, United States

Location

Research Institute of the Southeast, LLC

West Palm Beach, Florida, 33401, United States

Location

Shideler Clinical Research Center

Carmel, Indiana, 46032, United States

Location

William Coleman III, MD, APMC

Metairie, Louisiana, 70006, United States

Location

Lupo Center for Aesthetic & General Dermatology

New Orleans, Louisiana, 70124, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

JUVA Skin and Laser Center

New York, New York, 10021, United States

Location

Skin Search of Rochester, Inc.

Rochester, New York, 14623, United States

Location

PMG Research of Cary

Cary, North Carolina, 27518, United States

Location

Allus Clinical Research

Jenkintown, Pennsylvania, 19046, United States

Location

Dermatology and Laser Center of Charleston, PA

Charleston, South Carolina, 29414, United States

Location

The Skin Wellness Center

Knoxville, Tennessee, 37922, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Westlake Dermatology Clinical Research Center

Austin, Texas, 78746, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Virginia Clinical Research Inc.

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

IR-CTRegistration@allergan.com

1-877-277-8566

Study Officials

• Joan-En Lin

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: June 24, 2015
• Study Start: June 3, 2015
• Primary Completion: February 29, 2016
• Study Completion: February 29, 2016
• Last Updated: September 20, 2017
• Results First Posted: September 20, 2017

Record last verified: 2017-08

Locations

US (19)