NCT01799824

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

December 10, 2013

Status Verified

November 1, 2013

Enrollment Period

5 months

First QC Date

February 25, 2013

Last Update Submit

November 15, 2013

Conditions

Primary Axillary Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

  • HDSS

    Week 8

Secondary Outcomes (1)

  • GSP

    Week 8

Study Arms (2)

Active

EXPERIMENTAL

ANT-1403

Biological: ANT-1403

Vehicle

PLACEBO COMPARATOR

Vehicle

Biological: placebo

Interventions

ANT-1403BIOLOGICAL
Active
placeboBIOLOGICAL
Vehicle

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • diagnosis of secondary hyperhidrosis
  • skin affliction in the axilla requiring medical treatment
  • % 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Miami, Florida, 33137, United States

Location

Unknown Facility

Pinellas Park, Florida, 33781, United States

Location

Unknown Facility

West Palm Beach, Florida, 33401, United States

Location

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

East Windsor, New Jersey, 08520, United States

Location

Unknown Facility

Rochester, New York, 14623, United States

Location

Unknown Facility

Raleigh, North Carolina, 27612, United States

Location

Unknown Facility

Yardley, Pennsylvania, 19067, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

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

February 25, 2013

First Posted

February 27, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

December 10, 2013

Record last verified: 2013-11

Locations

US(9)