Severe Primary Hand Hyperhidrosis Treatment With Topical Administration of Victorhy

NCT06645509 | Terminated Phase 2

• 2 other identifiers: Dry002-FiH2023-507114-27-00
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

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.

Conditions

Palmar Hyperhidrosis

Keywords

Hyperhidrosis; Palmar Hyperhidrosis; Primary Palmar Hyperhidrosis; Sweat Gland Diseases; Cholinergic 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

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)

Drug: Placebo

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: Victorhy

Victorhy (dose 2) (TTB gel)

Placebo DRUG

A topical administration of a vehicle (Placebo) gel to both hands, once daily for 28 days

Vehicle gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• Be 18 years of age or older.
• Be willing to comply with the study protocol.
• Be males, or non-pregnant and non-lactating females (a negative urine pregnancy test is required for female participants of child-bearing potential).
• Have a primary hand hyperhidrosis diagnosis for at least 6 months.
• Have a HDSS of 3 or 4 at randomization/day 1.
• Have a gravimetric test of at least 100 mg of sweat production at rest in each palm, and a sum of at least 250 mg in both palms, in 5 minutes (room temperature) AND/OR being on a waiting list for surgical sympathectomy.
• Be willing to discontinue their current treatment for primary hyperhidrosis.
• In the case of women and men of childbearing potential, for safety reasons, those who agree to follow the required contraceptive measures from the signing of the informed consent until the last study visit (day 35).

You may not qualify if:

• Subjects meeting any of the following criteria are not eligible for study participation:
• Prior surgical procedure for hyperhidrosis.
• Iontophoresis for the palms 4 weeks prior to randomization.
• Treatment with botulinum toxin (e.g., Botox) for hand hyperhidrosis 6 months prior to randomization.
• Known allergy to any of the components in the investigational product, as well as to atropine or its derivatives, e.g., ipratropium or oxitropium.
• Subjects who are actively participating in an experimental therapy study or who received experimental therapy 30 days or 5 half-lives (whichever is longer) prior to randomization.
• Subjects who have had a change in a regimen of psychotherapeutic medication (change in drug, dose, frequency) or who have started a psychoactive medication prior to two months of randomization.
• Treatment with medications having systemic anticholinergic activity, centrally acting alpha-2 adrenergic agonists (e.g., clonidine, guanabenz, methyl dopa), or beta-blockers 4 weeks prior to randomization.
• Treatment with Spiriva or similar, or any systemic treatment with an anticholinergic medication such as, but not limited to atropine belladonna, scopolamine, aclidinium, hyoscyamine, oxybutynin or glycopyrronium within 4 weeks prior to randomization.
• Prior diagnosis of asthma or Chronic Obstructive Pulmonary Disease (COPD).
• If female, current pregnancy or lactation.
• Patients with skin lesions or bruisers; open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands.
• Secondary hand hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication, carcinoid syndrome, substance abuse, hyperthyroidism).
• Known history of Sjögren's syndrome or Sicca syndrome.
• Known history of neuromuscular disease.

Sponsors & Collaborators

• Dryox Health: lead

Study Sites (4)

Hospital Santa Caterina de Salt

Salt, Girona, 17190, Spain

Location

Hospital Vithas Nosa Señora de Fátima (Hospital Vithas Vigo)

Vigo, Pontevedra, 36206, Spain

Location

Hospital Pardo de Aravaca (Hospital Universitario Vithas Madrid Aravaca)

Madrid, 28023, Spain

Location

Hospital Vithas Parque San Antonio (Hospital Vithas Málaga)

Málaga, 29016, Spain

Location

MeSH Terms

Conditions

Hyperhidrosis; Sweat Gland Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin 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

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
• Primary Completion: June 2, 2025
• Study Completion: June 2, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

ES (4)