A phase 2, randomised, double-blind, vehicle-controlled, dose finding, efficacy, tolerability and safety study of Victorhy in patients with severe hand hyperhidrosis - Dry002-FiH

Dryox Health S.L.0 sites60 target enrollmentSeptember 13, 2023

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Dryox Health S.L.
Enrollment: 60
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 13, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Dryox Health S.L.

Eligibility Criteria

Inclusion Criteria

•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 subjects of child\-bearing potential)., Have a primary hand hyperhidrosis diagnosis for at least 6 months., Have a HDSS of 3 or 4 at randomisation/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\).

Exclusion Criteria

•Prior surgical procedure for hyperhidrosis., 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., History of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile illness, paralytic ileus, unstable cardiovascular status in acute haemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia gravis., Men with a history of urinary retention requiring catheterisation due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy., 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)., 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., Iontophoresis for the palms 4 weeks prior to randomisation., Treatment with botulinum toxin (e.g., Botox®) for hand hyperhidrosis 6 months prior to randomisation., 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 randomisation., 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 randomisation., 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 randomisation., Inhaled tiotropium bromide treatment (e.g. Spiriva®) 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 randomisation., Prior diagnosis of asthma or COPD.