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Clinical evaluation of terbinafine dissolvable microneedle in the treatment of onychomycosis

Clinical evaluation of terbinafine dissolvable microneedle in the treatment of onychomycosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050376
Enrollment
Unknown
Registered
2021-08-26
Start date
2022-06-01
Completion date
Unknown
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onychomycosis

Interventions

Experimental group:Terbinafine dissolvable microneedle
Control Group:Itraconazole

Sponsors

Shanghai Skin Disease Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. According to the history, physical signs and laboratory examination, the patients with onychomycosis were diagnosed clinically; 2. Direct microscopic examination and/or fungal culture were positive; 3. Aged >=18 years, male or female; 4. Patients with panychomycosis or proximal subungual onychomycosis (no apparent thickening of the nail plate), and OSI score 8-10.

Exclusion criteria

Exclusion criteria: 1. Local exudation or combined with active bacteria and virus infection; 2. Those suffering from neuropsychiatric diseases or being treated with other drugs that affect the curative effect; 3. Psoriasis patients; 4. Patients who had been treated with antifungal agents or glucocorticoids within 4 weeks before enrollment; 5. Patients who had topical antifungal drugs within 2 weeks before enrollment; 6. Participants in other drug trials within 30 days before screening.

Design outcomes

Primary

MeasureTime frame
Onychomycosis Severity Index;

Secondary

MeasureTime frame
Mycological detection;

Countries

China

Contacts

Public ContactTan Jingwen

Shanghai Skin Disease Hospital

cecilia88903@tongji.edu.cn+86 18017336766

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026