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.

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

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.