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NCT01799824 Clinical Trial

Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis

Primary Axillary Hyperhidrosis Clinical Trial

Official title:
Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis in Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01799824
Other study ID # ANT-1403-HHID-202
Secondary ID
Status Completed
Phase Phase 2
First received February 25, 2013
Last updated November 15, 2013
Start date February 2013
Est. completion date July 2013

Study information
Verified date November 2013
Source Anterios Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to confirm the effect of ANT-1403 in the treatment of primary axillary hyperhidrosis.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- ages 18 - 70 years of age

- diagnosis of moderate to severe primary axillary hyperhidrosis

- =50 mg of sweat production/axilla in 5 minutes as measured gravimetrically

- HDSS score of =3

Exclusion Criteria:

- diagnosis of secondary hyperhidrosis

- skin affliction in the axilla requiring medical treatment

- 20% aluminum hydrochloride, e.g. Drysol®, in 2 weeks prior of Baseline

- oral anticholinergic treatment

- botulinum toxin treatment in the prior 9 months

- history of surgery for axillary hyperhidrosis

- present or history of neuromuscular disease

- female subjects who are pregnant or are nursing a child

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• ANT-1403

• placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Anterios Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary HDSS Week 8 No
Secondary GSP Week 8 No
See also
  Status Clinical Trial Phase
Completed NCT03627468 - A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis Phase 3
Completed NCT03658616 - Assessment of Efficacy and Safety of Topical Administration of 1% Glycopyrronium Bromide (GPB) in Patients With Primary Axillary Hyperhidrosis and the Assessment of Long-term Efficacy and Safety of Topical Administration of 1% GPB Cream in Patients With Primary Axillary Hyperhidrosis. Phase 3
Completed NCT02286765 - Ulthera® System for Treating Axillary Hyperhidrosis N/A
Completed NCT04599907 - Evaluation of N-SWEAT Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating N/A
Completed NCT03037788 - Investigation of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in Subjects With Axillary Hyperhidrosis Phase 1
Terminated NCT01722461 - A Study of the Ulthera® System for the Treatment of Axillary Hyperhidrosis N/A
Completed NCT05863104 - Assessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents With Severe Primary Hyperhidrosis Phase 2
Completed NCT02823340 - Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis N/A
Not yet recruiting NCT04159610 - Assessment of Safety, Tolerability and Efficacy of 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% Under Maximum-Use Conditions in Subjects With Primary Axillary Hyperhidrosis Phase 2
Completed NCT03785587 - A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis Phase 2
Completed NCT03054480 - Fractional Micro-Needle Radiofrequency and I Botulinum Toxin A for Primary Axillary Hyperhidrosis N/A