Study on the Topical Use of Oxybutynin for Dyshidrosis

JRCT ID: jRCTs051240187

Registered date:18/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dyshidrosis
• Date of first enrollment: 18/11/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Apply 5 pumps (approximately 96 mg) of the investigational drug (Oxybutynin hydrochloride lotion) to the entire randomly assigned side palm once daily before bedtime.

Outcome(s)

• Primary Outcome: Evaluate the change in pruritus Numeric Rating Scale (NRS) from baseline (Day 0) to 4 weeks after treatment initiation.

Secondary Outcome

(Efficacy endpoints)
-Evaluate the change in pruritus Numeric Rating Scale (NRS) at each of the following time points relative to treatment initiation(Day 0): 1, 2, 3, and 6 weeks.
-Evaluate the change in Dermatology Life Quality Index (DLQI) at each of the following time points relative to treatment initiation(Day 0): 1, 2, 3, 4, and 6 weeks.
-Evaluate the change in Dyshidrosis Area and Severity Index (DASI) at each of the following time points relative to treatment initiation(Day 0): 1, 2, 3, 4, and 6 weeks.

(Safety endpoints)
Disease occurrence during the observation period

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1. Patients aged 18 to under 80 years at the time of obtaining consent.
2. Patients who are clinically diagnosed with pompholyx on both palms by a dermatologist.
3. Patients with an NRS score of 4 or higher for pruritus on both palms.
4. Patients who have provided written informed consent to participate in this clinical study of their own free will.

Exclude criteria

1. Patients with a history of allergy to investigational drugs, anticholinergic medications, or nitrile rubber gloves.
2. Patients with skin conditions other than dyshidrosis that involve pruritus on both palms (eczema, atopic dermatitis, urticaria, etc.).
3. Patients with conditions thought to affect sweating (diabetes, connective tissue diseases, thyroid disorders, psychiatric disorders, etc.).
4. Patients who have undergone or are undergoing treatments that may affect sweating:
- Within 1 week before screening:
- Over-the-counter drugs or quasi-drugs for palmar hyperhidrosis (antiperspirants, etc.)
- Within 4 weeks before screening:
- Aluminum chloride topical agents
- Medical devices for palmar hyperhidrosis (iontophoresis, etc.)
- Cholinergic, serotonin antagonist, or dopamine agonist medications
- Anticholinergic medications (excluding those for local treatment purposes that do not affect the evaluation of palmar hyperhidrosis)
- Within 8 weeks before screening:
- Medications for psychiatric disorders
- Within 1 year before screening:
- Local injection therapy with botulinum toxin for palmar hyperhidrosis
- Anytime:
- Surgical procedures for hyperhidrosis (regardless of site, including sympathetic nerve block, nerve block, laser surgery, etc.)
5. Patients requiring continued use of treatments that may affect pruritus assessment post consent:
- Antihistamines, corticosteroids, immunosuppressants, medications for psychiatric disorders, and any over-the-counter topical medications for the evaluation site.
6. Patients who are pregnant or breastfeeding.
7. Patients with narrow-angle glaucoma.
8. Patients with lower urinary tract obstruction causing urinary retention.
9. Patients with severe cardiac conditions.
10. Patients with intestinal obstruction or paralytic ileus.
11. Patients with severe myasthenia gravis.
12. Patients with dementia (due to concerns about anticholinergic effects).
13. Other patients deemed unsuitable by the study investigator for this clinical study.

Related Information

• Primary Sponsor: Fujiwara Susumu
• Secondary Sponsor: Kubo Akiharu