Phase 2
N=145
Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis
Hyperhidrosis
Bottom Line
View on ClinicalTrials.gov: NCT02479139 ↗Enrolled (actual)
145
Serious AEs
0.7%
Results posted
Sep 2017
Primary outcome: Primary: Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50% — 3.70; 13.64; 17.86; 14.29 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vehicle (Biological); ANT-1207 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50% |
3.70; 13.64; 17.86; 14.29; 14.29; 12.00 | — |
| SECONDARY Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points |
29.63; 13.64; 21.43; 9.52; 28.57; 16.00 | — |
| SECONDARY Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% |
62.96; 72.73; 71.43; 71.43; 61.90; 72.00 | — |
Summary
The purpose of this study is to establish the therapeutic range of ANT-1207 in the treatment of primary axillary hyperhidrosis.
Eligibility Criteria
Inclusion Criteria
- ages 18 - 70 years of age
- diagnosis of primary axillary hyperhidrosis
- HDSS score of ≥3
- threshold sweat production/axilla in 5 minutes as measured gravimetrically
- willingness to shave underarms prior to each study visit
Exclusion Criteria
- botulinum toxin treatment in the prior 6 months
- signs of infection in the axilla
- skin affliction in the axilla requiring medical treatment
- oral anticholinergic treatment
- use of antiperspirants, deodorants, powders, or lotions
- use of axillary depilatories or axillary epilation
- history of surgery or other interventions for axillary hyperhidrosis
- female subjects who are pregnant or are nursing a child
Data sourced from ClinicalTrials.gov (NCT02479139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.