Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis

Hyperhidrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565732
• Other study ID #: RT001-CL045
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2015
• Last updated: August 2, 2016
• Start date: September 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Revance Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a safety and efficacy study of botulinum toxin type A in subjects with primary axillary hyperhidrosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary axillary hyperhidrosis

• Female or male, 18 years of age or older in good general health

• Excessive sweating interferes with daily life activities and scores 3 or 4 on the HDSS at Screening and Baseline

• Axillary sweat production of at least 50 mg/5 min measured gravimetrically

Exclusion Criteria:

• Any neurological condition, that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and Myasthenia gravis

• Muscle weakness or paralysis, particularly in the upper extremities

• Active skin disease or irritation or disrupted barrier at the treatment area

• Undergone any procedures which may affect the axillary areas

• Treatment with botulinum toxin type A in the axilla in the last 9 months or anywhere in the body in the last 6 months

• Any prior axillary use of an anti-hyperhidrosis medical device

• If menopausal had symptoms of menopause such as sweating or flushing within the last year

Study Design

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

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Biological:
• Botulinum toxin type A
Botulinum toxin type A, Dose A, Topical
• Botulinum toxin type A
Botulinum toxin type A, Dose B, Topical
• Placebo comparator
Placebo, Dose C, Topical

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Revance Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperhidrosis Disease Severity Scale (HDSS)	Improvement at follow-up in the experimental groups compared to the placebo group	Week 4	No
Primary	Gravimetry	The amount of sweat measured gravimetrically	Week 4	No
Secondary	Dermatology Life Quality Index (DLQI)		Week 4	No