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

NCT02565732 | Completed Phase 2

• 1 other identifier: RT001-CL045
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (2)

• Hyperhidrosis Disease Severity Scale (HDSS)

  Improvement at follow-up in the experimental groups compared to the placebo group

  Week 4

• Gravimetry

  The amount of sweat measured gravimetrically

  Week 4

Secondary Outcomes (1)

• Dermatology Life Quality Index (DLQI)

  Week 4

Study Arms (3)

Dose A

EXPERIMENTAL

Botulinum toxin type A

Biological: Botulinum toxin type A

Dose B

EXPERIMENTAL

Botulinum toxin type A

Biological: Botulinum toxin type A

Dose C

PLACEBO COMPARATOR

Placebo comparator

Biological: Placebo comparator

Interventions

Botulinum toxin type A BIOLOGICAL

Botulinum toxin type A, Dose A, Topical

Dose A

Placebo comparator BIOLOGICAL

Placebo, Dose C, Topical

Dose C

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Revance Therapeutics, Inc.: lead

Study Sites (1)

Unknown Facility

San Francisco, California, 94117, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

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

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 1, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: August 4, 2016

Record last verified: 2016-03

Locations

US (1)