NCT06645509

Severe Primary Hand Hyperhidrosis Treatment With Topical Administration of Victorhy

A Phase 2, Randomised, Double-blind, Vehicle-controlled, Dose Finding, Efficacy, Tolerability and Safety Study of Victorhy in Patients With Severe Hand Hyperhidrosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Dryox Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the efficacy and safety of Victorhy, a topical TTB gel in patients with severe primary hand hyperhidrosis.

Detailed description

This is a Phase II, multicenter, randomized, double-blind, parallel group and vehicle-controlled study in which participants with severe primary hand hyperhidrosis will be randomly assigned (1:1:1) to one of the following arms: * Victorhy dose 1 * Victorhy dose 2 * Placebo (Vehicle gel) This study will evaluate the efficacy of Victorhy, a topical TTB gel, in patients with severe primary hand hyperhidrosis. This trial will also assess the quality of life of study participants, the rebound effect, and the pharmacokinetics of topical TTB gel. The study is intended to assess a formulation including two different doses of Victorhy (treatment groups), compared to placebo (control group) with the objective of determining the optimal therapeutic dose for use in severe hand hyperhidrosis. Objectives: Primary objective: To assess the efficacy of a topical TTB gel in patients with severe primary hand hyperhidrosis. Secondary objectives: * To assess the tolerability and safety of topical TTB gel * To determine the optimal therapeutic dose of topical TTB gel * To assess the quality of life of study participants * To assess the rebound effect

Conditions

• Palmar Hyperhidrosis

Interventions

Type	Name	Description
DRUG	TTB gel (dose 1)	A topical administration of Victorhy (TTB gel) to both hands, once daily for 28 days
DRUG	TTB gel (dose 2)	A topical administration of Victorhy (TTB gel) to both hands, once daily for 28 days
DRUG	Placebo	A topical administration of a vehicle (Placebo) gel to both hands, once daily for 28 days

Timeline

• Start date: 2024-04-29
• Primary completion: 2025-06-02
• Completion: 2025-06-02
• First posted: 2024-10-17
• Last updated: 2025-06-22

Locations

4 sites across 1 country: Spain