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.
⁃ 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).