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

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.

Study Overview

• Status: Terminated
• Conditions: Palmar Hyperhidrosis
• Intervention / Treatment: Drug: TTB gel (dose 1); Drug: TTB gel (dose 2); Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28023
    • Hospital Pardo de Aravaca (Hospital Universitario Vithas Madrid Aravaca)
  • Málaga, Spain, 29016
    • Hospital Vithas Parque San Antonio (Hospital Vithas Málaga)
  • Girona
    • Salt, Girona, Spain, 17190
      • Hospital Santa Caterina de Salt
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36206
      • Hospital Vithas Nosa Señora de Fátima (Hospital Vithas Vigo)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Subjects must meet all the following criteria to be eligible for study participation:

1. To sign an informed consent.
2. Be 18 years of age or older.
3. Be willing to comply with the study protocol.
4. Be males, or non-pregnant and non-lactating females (a negative urine pregnancy test is required for female participants of child-bearing potential).
5. Have a primary hand hyperhidrosis diagnosis for at least 6 months.
6. Have a HDSS of 3 or 4 at randomization/day 1.
7. 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.
8. Be willing to discontinue their current treatment for primary hyperhidrosis.
9. 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).

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for study participation:

1. Prior surgical procedure for hyperhidrosis.
2. Iontophoresis for the palms 4 weeks prior to randomization.
3. Treatment with botulinum toxin (e.g., Botox) for hand hyperhidrosis 6 months prior to randomization.
4. Known allergy to any of the components in the investigational product, as well as to atropine or its derivatives, e.g., ipratropium or oxitropium.
5. 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.
6. 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.
7. 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.
8. 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.
9. Prior diagnosis of asthma or Chronic Obstructive Pulmonary Disease (COPD).
10. If female, current pregnancy or lactation.
11. 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.
12. 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).
13. Known history of Sjögren's syndrome or Sicca syndrome.
14. Known history of neuromuscular disease.
15. History of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile illness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia gravis.
16. Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
17. History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia with a ventricular rate greater than 100 (other than sinus tachycardia).
18. Subjects who are a high medical risk because of other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Victorhy (dose 1) (TTB gel); Participants will receive Victorhy (TTB, dose 1) topically to both hands, once daily for 28 days (20 participants)	Drug: TTB gel (dose 1); A topical administration of Victorhy (TTB gel) to both hands, once daily for 28 days; Other Names: Victorhy
Experimental: Victorhy (dose 2) (TTB gel); Participants will receive Victorhy (TTB, dose 2) topically to both hands, once daily for 28 days (20 participants)	Drug: TTB gel (dose 2); A topical administration of Victorhy (TTB gel) to both hands, once daily for 28 days; Other Names: Victorhy
Placebo Comparator: Vehicle gel; Participants will receive a vehicle gel topically to both hands, once daily for 28 days (20 participants)	Drug: Placebo; A topical administration of a vehicle (Placebo) gel to both hands, once daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Impression of Change	Overall impression of the hand sweating of the participants at day 29 compared to before treatment, ranging from 1 (much better) to 7 (much worse). It is the patients who provide their assessment of this outcome.	From Day 1 to Day 29
Proportion of participants who have an equal to or higher than 1 grade improvement in HDSS	An improvement of 1 or more grades in the HDSS.	From Day 1 to Day 29
Proportion of participants who have an equal to or higher than 2 grade improvement in HDSS	An improvement of 2 or more grades in the HDSS.	From Day 1 to Day 29
Proportion of participants who have at least a 50 percent reduction in gravimetrically measured sweat production	A positive case is defined as a patient who showed a reduction of 50 percent or more in gravimetrically measured sweat production compared to day 1.	From Day 1 to Day 29
Percent change in gravimetrically-measured sweat production	Percent change from day 1 to day 29 in the gravimetrically-measured sweat production.	From Day 1 to Day 29
Hyperhidrosis Quality of Life Index (HidroQoL) to Evaluate the Quality of Life of the Study Participants	The HidroQoL assesses how hyperhidrosis impacts Quality of life. With 18 items on two domains, it is a comprehensive measure. The first domain with six items refers to daily life activities and the second domain with 12 items covers the psychosocial life of participants. Each item has three response options (no, not at all = 0; a little = 1; very much = 2), with a total score range from 0 to 36. The higher the score, the greater the severity. To compute scores for each dimension, items must be summed. It is the patients who provide their assessment of this outcome.	From Day 1 to Day 29
Dermatology Life Quality Index (DLQI) to Evaluate Quality of Life of Study Participants	It consists of 10 questions referring to the past seven days. Each question of the questionnaire includes a Likert-type scale with four possible answers: "not at all", "a little", "a lot" or "very much", with scores of 0, 1, 2 and 3 respectively, with an additional option of "not relevant". The health domains included are symptoms and perceptions (questions 1, 2), daily activities (3, 4), leisure (5, 6), work/study (7), interpersonal relationships including sexuality (8, 9) and treatment (10). The sum of the scores provides a simple aggregate global value between 0 and 30, and the result can be presented as the percentage impact of the dermatologic condition on the patient's quality of life. The higher the score, the greater the impact on the patient's quality of life. It is the patients who provide their assessment of this outcome.	From Day 1 to Day 29
EQ-5D-5L Questionnaire to Evaluate the Quality of Life of the Study Participants	It is a standardized measure of health status that provides a simple, generic measure of health. It consists of 5 items in a 5-point Likert scale and a sixth item ranged from 0 to 100. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. It is the patients who provide their assessment of this outcome.	From Day 1 to Day 29
Local skins reactions (LSRs)	LSRs include burning/stinging, pruritus, oedema, erythema, dryness, and scaling. Each LSR will be scored as 0 (None), 1 (Mild), 2 (Moderate) or 3 (Severe). LSRs observed on a study visit day are not recorded as adverse events unless scored as 3 (Severe).	From Day 1 to Day 29
Rebound effect assessment	To assess if on Day 35 there is an increase of 1 or more over the HDSS value obtained on Day 29 (End of Treatment Visit).	From Day 1 to Day 35

Collaborators and Investigators

• Sponsor: Dryox Health
• Investigators: Principal Investigator: 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)

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2024
• Primary Completion (Actual): June 2, 2025
• Study Completion (Actual): June 2, 2025

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Hyperhidrosis; Sweat Gland Diseases; Palmar Hyperhidrosis; Cholinergic Antagonists; Primary Palmar Hyperhidrosis
• Additional Relevant MeSH Terms: Skin Diseases; Sweat Gland Diseases; Hyperhidrosis
• Other Study ID Numbers: Dry002-FiH; 2023-507114-27-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No