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Completed

NCT Number: NCT02479139

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

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

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Key information

Conditions

Hyperhidrosis Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Marcus Research Clinic, Inc., Hialeah, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vehicle

Biological

Vehicle for ANT-1207 liniment formulation without active ingredient.

ANT-1207

Biological

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

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%

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 24, 2015
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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