Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645509
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Severe Primary Hand Hyperhidrosis Treatment With Topical Administration of Victorhy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomised Double-blind Vehicle-controlled Dose Finding Efficacy Tolerability and Safety Study of Victorhy in Patients With Severe Hand Hyperhidrosis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 111 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None