A Dose-Ranging Study of the Effect of DRM04B in Subjects With Axillary Hyperhidrosis

Brief Summary

Official Title: “A Phase 2, Randomized, Double-Blind, Vehicle Controlled, Dose-Ranging Study of the Effect of DRM04B in Subjects With Axillary Hyperhidrosis”

The purpose of this study is to evaluate the safety and efficacy of DRM04B compared to vehicle for the treatment of axillary hyperhidrosis.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: July 2014

Detailed Clinical Trial Description

This is a randomized, vehicle controlled, dose-ranging study enrolling subjects with axillary hyperhidrosis and designed to assess the safety and efficacy of four doses of DRM04B compared to vehicle. There are 5 arms in this study.

Efficacy will be assessed through the Hyperhidrosis Disease Severity Score (HDSS), Dermatology Life Quality Index (DLQI) and a gravimetric assessment of sweat production.

Safety will be assessed, at specified times during the study, through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.

PK samples will be taken from 20 to 30 subjects participating in the study.

Interventions Used in this Clinical Trial

  • Drug: DRM04B, 1.0%
  • Drug: DRM04B, 2.0%
  • Drug: DRM04B, 3.0%
  • Drug: DRM04B, 4.0%
  • Other: Vehicle

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: DRM04B, 1.0%
    • DRM04B, 1.0%
  • Experimental: DRM04B, 2.0%
    • DRM04B, 2.0%
  • Experimental: DRM04B, 3.0%
    • DRM04B, 3.0%
  • Experimental: DRM04B, 4.0%
    • DRM04B, 4.0%
  • Placebo Comparator: Vehicle
    • Vehicle

Outcome Measures for this Clinical Trial

Primary Measures

  • Proportion of subjects who have a minimum 2-grade improvement in HDSS from baseline.
    • Time Frame: Week 4
      Safety Issue?: No
  • Absolute change in the gravimetrically measured sweat production.
    • Time Frame: Week 4
      Safety Issue?: No

Secondary Measures

  • Proportion of subjects who have a minimum 1-grade improvement in HDSS.
    • Time Frame: Week 4
      Safety Issue?: No
  • Absolute change in the gravimetrically measured sweat.
    • Time Frame: Week 6
      Safety Issue?: No
  • Proportion of subjects who have a minimum 1-grade improvement in HDSS.
    • Time Frame: Week 6
      Safety Issue?: No
  • Dermatology Life Quality Index (DLQI)
    • Time Frame: Week 4
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Male or female, 18 years of age or older.
  • Primary, axillary hyperhidrosis of at least 6 months duration.
  • A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4.
  • A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature.
  • Male or non-pregnant, non-lactating females.

Exclusion Criteria

  • Prior surgical procedure for hyperhidrosis.
  • Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational)
  • Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.
  • Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. Treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment.
  • Prior axillary treatment with axillary iontophoresis within 4 weeks.
  • Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
  • Known history of a condition that may cause secondary hyperhidrosis.
  • Known history of Sj√∂gren's syndrome or Sicca syndrome.
  • Abnormal findings on screening ECG deemed clinically significant by the Investigator.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Dermira, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lynne M Deans, MT, Study Director, Dermira, Inc.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT02016885