Effects of a new topical treatment, Victorhy, in patients with severe hand hyperhidrosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dryox Health S.L., Dryox Health S.L.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

28 Feb 2024 → 2 Jun 2025

Decision date (initial)

2024-01-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Dryox Health S.L.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Dose response, Safety, Pharmacokinetic

To assess the efficacy of topical tiotropium bromide gel.

Secondary objectives 4

1. To assess the tolerability and safety of topical tiotropium bromide gel.
2. To determine the optimal therapeutic dose of topical tiotropium bromide gel
3. To assess the quality of life of study participants
4. To assess the rebound effect

Conditions and MedDRA coding

Severe primary hand hyperhidrosis

Regulatory references

Scientific advice from competent authorities

Medicines Evaluation Board

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

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 subjects 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 randomisation/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 18

1. Prior surgical procedure for hyperhidrosis.
2. Iontophoresis for the palms 4 weeks prior to randomisation.
3. Treatment with botulinum toxin (e.g., Botox®) for hand hyperhidrosis 6 months prior to randomisation.
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 randomisation.
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 randomisation.
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 randomisation.
8. 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.
9. Prior diagnosis of asthma or 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 haemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia gravis.
16. Men with a history of urinary retention requiring catheterisation 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Mean absolute change from Day 1 in gravimetrically measured sweat production at Day 29.
2. Mean change in HDSS at Day 29 from Day 1.

Secondary endpoints 15

1. To assess the quality of life of the study participants with the Hyperhidrosis Quality of Life Index (HidroQol).
2. To assess the quality of life of the study participants with the DLQI
3. To assess the quality of life of the study participants with the EQ-5D-5L questionnaire.
4. Local skin reactions.
5. Number of adverse events per randomisation group.
6. Number of patients within each Adverse Event per randomisation group.
7. Type of Adverse Events per randomisation group.
8. Number of Serious Adverse Events by randomisation group.
9. Type of Serious Adverse Events by randomisation group.
10. Number of Adverse Events of Special Interest by randomisation group.
11. Type of Adverse Events of Special Interest by randomisation group.
12. Treatment-related Adverse Events.
13. Severity of Adverse Events.
14. To assess if on Day 35 there is an increase of 1 or more over the HDSS value obtained on Day 29 (End of Treatment Visit).
15. The determination of plasma levels of tiotropium bromide at pharmacokinetic steady state.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dryox Health S.L.

Sponsor organisation

Dryox Health S.L.

Address

Carrer De Arago 60 Pr 1

City

Barcelona

Postcode

08015

Country

Spain

Scientific contact point

Organisation

Dryox Health S.L.

Contact name

Mónica Tellechea

Public contact point

Organisation

Dryox Health S.L.

Contact name

Mónica Tellechea

Third parties 2

Dryox Health S.L.

Sponsor organisation

Dryox Health S.L.

Address

Calle Arago 60 Ppal 1a

City

Barcelona

Postcode

08015

Country

Spain

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

3 submissions — initial application plus substantial / non-substantial modifications