Conditions: Hyperhidrosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 105
Healthy volunteers: no

Brief summary:
The purpose of the study is to assess the safety of 2 doses of glycopyrrolate compared to 2 doses of glycopyrronium and vehicle (5 treatment arms) for the treatment of axillary hyperhidrosis when applied once daily for 4 weeks followed by a 2-week post-dose period.

Detailed description:
This is a randomized, double-blind, vehicle controlled, parallel group, comparator study designed to assess the safety, efficacy and pharmacokinetics of two doses of glycopyrrolate compared to two doses of glycopyrronium compared to vehicle, 5 treatment arms.

Efficacy will be assessed through gravimetric assessment of sweat production using Patient Reported Outcome and the Hyperhidrosis Disease Severity Score (HDSS).

Safety will be assessed through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.

PK blood samples will be taken study subjects.

Arms:
arm 1: glycopyrrolate Topical Wipes arm 2: glycopyrrolate Topical Wipes arm 3: glycopyrronium Topical Wipes arm 4: glycopyrronium Topical Wipes arm 5: Vehicle Topical Wipes

Interventions: intervention 1: Dose 1 of glycopyrrolate, 2.0% QD intervention 2: Dose 2 of glycopyrrolate, 3.0% QD intervention 3: Dose 1 of glycopyrronium, 2.5% QD intervention 4: Dose 2 of glycopyrronium, 3.75% QD intervention 5: Vehicle
Intervention descriptions: intervention 1: Dose 1 of glycopyrrolate Topical Wipes intervention 2: Dose 2 of glycopyrrolate Topical Wipes intervention 3: Dose 1 of glycopyrronium Topical Wipes intervention 4: Dose 2 of glycopyrronium Topical Wipes intervention 5: Vehicle Topical Wipes

Protocol document: