Trials Sponsors Conditions Drugs Pricing

Conditions

Severe primary hand hyperhidrosis Palmar Hyperhidrosis

Keywords

HyperhidrosisPalmar HyperhidrosisPrimary Palmar HyperhidrosisSweat Gland DiseasesCholinergic Antagonists

Outcome Measures

Primary Outcomes (2)

Mean absolute change in gravimetrically measured sweat production
From Day 1 to Day 29
Mean change in Hyperhidrosis Disease Severity Scale (HDSS)
HDSS is a scale from grade 1 to grade 4 to measure the level of interference of sweat production with the patient's daily activities. It is the participants who give their subjective assessment, which may be: * Grade 1: My sweating is never noticeable and never interferes with my daily activities. * Grade 2: My sweating is tolerable but sometimes interferes with my daily activities. * Grade 3: My sweating is barely tolerable and frequently interferes with my daily activities. * Grade 4: My sweating is intolerable and always interferes with my daily activities.
From Day 1 to Day 29

Secondary Outcomes (10)

Global Impression of Change
From Day 1 to Day 29
Proportion of participants who have an equal to or higher than 1 grade improvement in HDSS
From Day 1 to Day 29
Proportion of participants who have an equal to or higher than 2 grade improvement in HDSS
From Day 1 to Day 29
Proportion of participants who have at least a 50 percent reduction in gravimetrically measured sweat production
From Day 1 to Day 29
Percent change in gravimetrically-measured sweat production
From Day 1 to Day 29
+5 more secondary outcomes

Study Arms (3)

Victorhy (dose 1) (TTB gel)

EXPERIMENTAL

Participants will receive Victorhy (TTB, dose 1) topically to both hands, once daily for 28 days (20 participants)

Drug: TTB gel (dose 1)

Victorhy (dose 2) (TTB gel)

EXPERIMENTAL

Participants will receive Victorhy (TTB, dose 2) topically to both hands, once daily for 28 days (20 participants)

Drug: TTB gel (dose 2)

Vehicle gel

PLACEBO COMPARATOR

Participants will receive a vehicle gel topically to both hands, once daily for 28 days (20 participants)

Interventions

TTB gel (dose 1)Drug

A topical administration of Victorhy (TTB gel) to both hands, once daily for 28 days

Also known as: Victorhy

Victorhy (dose 1) (TTB gel)

TTB gel (dose 2)Drug

A topical administration of Victorhy (TTB gel) to both hands, once daily for 28 days

Also known as:

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects must meet all the following criteria to be eligible for study participation:
To sign an informed consent.

Sponsors & Collaborators

Dryox Health S.L.
Industrylead
Dryox Health
Industrylead

Study Sites (4)

Hospital Santa Caterina de Salt

Salt, Girona, 17190, Spain

Hospital Vithas Nosa Señora de Fátima (Hospital Vithas Vigo)

Vigo, Pontevedra, 36206, Spain

Hospital Pardo de Aravaca (Hospital Universitario Vithas Madrid Aravaca)

Madrid, 28023, Spain

Hospital Vithas Parque San Antonio (Hospital Vithas Málaga)

Málaga, 29016, Spain

MeSH Terms

Conditions

HyperhidrosisSweat Gland Diseases

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

Clara Matas Nada, MD
Hospital Santa Caterina de Salt
PRINCIPAL INVESTIGATOR
José Gregorio Álvarez Fernández, MD
Hospital Pardo de Aravaca (Hospital Universitario Vithas Madrid Aravaca)
PRINCIPAL INVESTIGATOR
Carmen Rodríguez Cerdeira, MD
Hospital Vithas Nosa Señora de Fátima (Hospital Vithas Vigo)
PRINCIPAL INVESTIGATOR
Enrique Herrera Acosta, MD
Hospital Vithas Parque San Antonio (Hospital Vithas Málaga)
PRINCIPAL INVESTIGATOR

Enrollment

58 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Masking Details: Blinding applies to Participant / Investigator \& study site personnel
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 15, 2024

First Posted

October 17, 2024

Study Start

April 29, 2024

Actual (reported)

Study Stopped

Severe Primary Hand Hyperhidrosis Treatment With Topical Administration of Victorhy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Study Arms (3)

Victorhy (dose 1) (TTB gel)

Victorhy (dose 2) (TTB gel)

Vehicle gel

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Study Arms (3)

Victorhy (dose 1) (TTB gel)

Victorhy (dose 2) (TTB gel)

Vehicle gel

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations