Severe Primary Hand Hyperhidrosis Treatment With Topical Administration of Victorhy (NCT06645509) | Clinical Trial Compass
TerminatedPhase 2
Severe Primary Hand Hyperhidrosis Treatment With Topical Administration of Victorhy
Stopped: The trial was early terminated due to a slower patient accrual than expected. By the expiration date of the IMP batch manufactured for the trial (30 May 2025), only 58 patients were enrolled, below the planned N of 60.
Spain58 participantsStarted 2024-04-29
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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.
Exclusion criteria
✕. Prior surgical procedure for hyperhidrosis.
✕. Iontophoresis for the palms 4 weeks prior to randomization.
✕. Treatment with botulinum toxin (e.g., Botox) for hand hyperhidrosis 6 months prior to randomization.
✕. Known allergy to any of the components in the investigational product, as well as to atropine or its derivatives, e.g., ipratropium or oxitropium.
What they're measuring
1
Mean absolute change in gravimetrically measured sweat production
Timeframe: From Day 1 to Day 29
2
Mean change in Hyperhidrosis Disease Severity Scale (HDSS)
. 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.
✕. 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.
✕. 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.
✕. 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.