Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02479139 | Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis | PHASE2 | COMPLETED | 145 | — | — | Jun 3, 2015 | Feb 29, 2016 | Sep 20, 2017 | 19 | United States |
The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities. GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. The HDSS and the GSP were assessed at Baseline and Week 12. The change from Baseline was calculated. The percentage of participants who had both a change (reduction) from Baseline in HDSS score by ≥ 2 points and a change (reduction) from Baseline in GSP by ≥ 50% is reported.
| Arm | Type | Description |
|---|---|---|
| Vehicle | PLACEBO_COMPARATOR | Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| ANT-1207 Dose 1 | EXPERIMENTAL | Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| ANT-1207 Dose 2 | EXPERIMENTAL | Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| ANT-1207 Dose 3 | EXPERIMENTAL | Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| ANT-1207 Dose 4 | EXPERIMENTAL | Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| ANT-1207 Dose 5 | EXPERIMENTAL | Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| Name | Type | Description |
|---|---|---|
| Vehicle | BIOLOGICAL | Vehicle for ANT-1207 liniment formulation without active ingredient. |
| ANT-1207 | BIOLOGICAL | Botulinum toxin Type A topical liniment (ANT-1207). |
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 ...