Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis

Study Overview
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Brief Summary
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The purpose of this study is to establish the therapeutic range of ANT-1207 in the treatment of primary axillary hyperhidrosis.

Official Title
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Clinical Trial to Evaluate ANT-1207 in the Treatment of Primary Axillary Hyperhidrosis in Adults

Conditions
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Hyperhidrosis

Intervention / Treatment
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* Biological: Vehicle
* Biological: ANT-1207


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br>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. | Biological: Vehicle<br>* Vehicle for ANT-1207 liniment formulation without active ingredient.<br>|
| Experimental: ANT-1207 Dose 1<br>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. | Biological: ANT-1207<br>* Botulinum toxin Type A topical liniment (ANT-1207).<br>|
| Experimental: ANT-1207 Dose 2<br>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. | Biological: ANT-1207<br>* Botulinum toxin Type A topical liniment (ANT-1207).<br>|
| Experimental: ANT-1207 Dose 3<br>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. | Biological: ANT-1207<br>* Botulinum toxin Type A topical liniment (ANT-1207).<br>|
| Experimental: ANT-1207 Dose 4<br>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. | Biological: ANT-1207<br>* Botulinum toxin Type A topical liniment (ANT-1207).<br>|
| Experimental: ANT-1207 Dose 5<br>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. | Biological: ANT-1207<br>* Botulinum toxin Type A topical liniment (ANT-1207).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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% | 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. | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points | 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. The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in HDSS score by ≥ 2 points is reported. | Baseline, Weeks 4, 8, 12 and 18 | 
| Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50% | 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 change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in GSP by ≥ 50% is reported. | Baseline, Weeks 4, 8, 12 and 18 |