Conditions: Hyperhidrosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 198
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.

Detailed description:
This is a randomized, vehicle controlled, dose-ranging study enrolling subjects with axillary hyperhidrosis and designed to assess the safety and efficacy of four doses of glycopyrrolate compared to vehicle. There are 5 arms in this study.

Efficacy will be assessed through the Hyperhidrosis Disease Severity Score (HDSS), Dermatology Life Quality Index (DLQI) and a gravimetric assessment of sweat production.

Safety will be assessed, at specified times during the study, through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.

PK samples will be taken from 20 to 30 subjects participating in the study.

Arms:
arm 1: glycopyrrolate Topical Wipes, 1.0% arm 2: glycopyrrolate Topical Wipes, 2.0% arm 3: glycopyrrolate Topical Wipes, 3.0% arm 4: glycopyrrolate Topical Wipes, 4.0% arm 5: Vehicle Topical Wipes

Interventions: intervention 1: glycopyrrolate, 1.0% intervention 2: glycopyrrolate, 2.0% intervention 3: glycopyrrolate, 3.0% intervention 4: glycopyrrolate, 4.0% intervention 5: Vehicle
Intervention descriptions: intervention 1: glycopyrrolate Topical Wipes, 1.0% intervention 2: glycopyrrolate Topical Wipes, 2.0% intervention 3: glycopyrrolate Topical Wipes, 3.0% intervention 4: glycopyrrolate Topical Wipes, 4.0% intervention 5: Vehicle Topical Wipes

Protocol document: