Severe Primary Hand Hyperhidrosis Treatment With Topical Administration of Victorhy

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 testis 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/ORbeing 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, thosewho agree to follow the required contraceptive measures from the signing of theinformed 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 priorto randomization.

4. Known allergy to any of the components in the investigational product, as well as toatropine or its derivatives, e.g., ipratropium or oxitropium.

5. Subjects who are actively participating in an experimental therapy study or whoreceived experimental therapy 30 days or 5 half-lives (whichever is longer) prior torandomization.

6. Subjects who have had a change in a regimen of psychotherapeutic medication (changein drug, dose, frequency) or who have started a psychoactive medication prior to twomonths of randomization.

7. Treatment with medications having systemic anticholinergic activity, centrallyacting alpha-2 adrenergic agonists (e.g., clonidine, guanabenz, methyl dopa), orbeta-blockers 4 weeks prior to randomization.

8. Treatment with Spiriva or similar, or any systemic treatment with an anticholinergicmedication 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 thehands or, any condition that may alter the barrier function of the skin on thehands.

12. Secondary hand hyperhidrosis or presence of a condition that may cause secondaryhyperhidrosis (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 febrileillness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severeulcerative colitis, toxic megacolon complicating ulcerative colitis or myastheniagravis.

16. Men with a history of urinary retention requiring catheterization due to prostatichypertrophy 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 activeuncontrolled infections, or any other condition which, in the judgment of theInvestigator, would put the subject at unacceptable risk for participation in thestudy.