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2940-nm Er: YAG fractional laser combined with Amorolfine hydrochloride and Amorolfine hydrochloride for treating onychomycosis: a prospective, randomized, controlled, Evaluator-blinded, parallel-group clinical trial

2940-nm Er: YAG fractional laser combined with Amorolfine hydrochloride and Amorolfine hydrochloride for treating onychomycosis: a prospective, randomized, controlled, Evaluator-blinded, parallel-group clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17013504
Enrollment
Unknown
Registered
2017-11-23
Start date
2018-01-01
Completion date
Unknown
Last updated
2017-11-27

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

Conditions

Onychomycosis

Interventions

combination group:2940-nm Er: YAG fractional laser combined with Amorolfine hydrochloride
single group:Amorolfine hydrochloride

Sponsors

Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) there are no gender limits for patients aged between 18 and 65 years; (2) patients with onychomycosis confirmed by clinical manifestations and fungal microscopy, the fungal direct microscopy was positive and the OSI score was greater than 1; (3) consent and consent to sign informed consent; (4) women of childbearing age agree to take effective contraceptive measures during the trial period.

Exclusion criteria

Exclusion criteria: (1) the affected areas may affect the evaluation of the skin diseases (such as methylitis, pterygium, etc.); (2) known history of allergy to romero liniment; (3) patients with severe immunosuppression or within 3 months of systemic use of glucocorticoid and immunosuppressive agents; (4) patients with severe heart, liver and kidney disease (ALT, AST > normal value of 2 times, Cr > normal value limit 1.2 times); (5) patients with severe neurological, mental illness and poor control of diabetes; (6) the application of antifungal drugs or antifungal drugs within 3 months prior to the treatment of antifungal drugs in the previous 2 weeks; (7) women who are pregnant, breast-feeding, planning to conceive or use improper contraception; (8) having a history of drug abuse; (9) have participated in other drug clinical trials within 3 months before treatment; (10) for other reasons, the researcher does not consider it suitable for participating in this test.

Design outcomes

Primary

MeasureTime frame
mycological clear rate;

Countries

China

Contacts

Public ContactZhang Jing
zhangj0811@126.com+86 13632499509

Outcome results

None listed

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