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Clinical evaluation of amorofen dissolvable microneedle in the treatment of onychomycosis

Clinical evaluation of amorofen dissolvable microneedle in the treatment of onychomycosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046586
Enrollment
Unknown
Registered
2021-05-22
Start date
2022-07-01
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

Onychomycosis

Interventions

Group A:amorofen dissolvable microneedle
Group B:Oral use Itraconazole

Sponsors

Shanghai Skin Disease Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

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 and female; 4. OSI score 8-10.

Exclusion criteria

Exclusion criteria: 1. Partially exuded or combined with active bacteria or virus infection; 2. Those who suffer from neuropsychiatric diseases or are using other medications that affect the curative effect; 3. Psoriasis patients; 4. Those who have systematically used antifungal agents or have used glucocorticoids systematically within 4 weeks before being selected; 5. Those who have used topical anti-fungal drugs within 2 weeks before being selected; 6. Participate 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