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

Allergan

Status and phase: Completed; Phase 2

Conditions: Hyperhidrosis

Treatments: Biological: ANT-1207; Biological: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02479139

ANT-1207-HHID-205

Details and patient eligibility

About

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

Enrollment: 145 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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145 participants in 6 patient groups, including a placebo group

Vehicle

Placebo Comparator group

Description:

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.

Treatment:

Biological: Vehicle

ANT-1207 Dose 1

Experimental group

Description:

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.

Treatment:

Biological: ANT-1207

ANT-1207 Dose 2

Experimental group

Description:

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.

Treatment:

Biological: ANT-1207

ANT-1207 Dose 3

Experimental group

Description:

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.

Treatment:

Biological: ANT-1207

ANT-1207 Dose 4

Experimental group

Description:

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.

Treatment:

Biological: ANT-1207

ANT-1207 Dose 5

Experimental group

Description:

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.

Treatment:

Biological: ANT-1207