onychomycosis
Conditions
Interventions
Group L+A:Q-switched Nd:YAG laser versus Amorolfine Hydrochloride Cream
Group L:Q-switched Nd:YAG laser
Group A:Amorolfine Hydrochloride Cream
Sponsors
Sun Yat-sen University No.5 Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Ability to understand, to agree to, and to sign the study informed consent form; 2.age 60 years or older; 3.Male or female individuals; 4.A clinical diagnosis of Distal lateral subungual onychomycosis,more than 25% involvement of at least one diseased nail; 5.Dermoscopic examinations performed positive for criteria of onychomycosis; 6.Willingness and ability to comply with study instructions, and commit to attending all visits;
Exclusion criteria
Exclusion criteria: 1.Anatomic abnormalities of the toe(s) or toenail(s) to be treated, including, but not limited to genetic nail disorders, pigmentary disorders, onychogryphosis, previous trauma to the toenail(s) to be treated, or other abnormality that in the investigators’ opinion may interfere with clinical evaluation of the toenail(s) or would indicate that the individual is unlikely to respond to topical treatment for onychomycosis; 2.Unwillingness or inability to use topical antifungal treatment; 3.Concurrent use of or have used any of the following topical or systemic medications within the indicated time frame prior to the screening: •Topical antifungals applied to the toenails: 4 weeks; •Topical anti-inflammatory, corticosteroid, or immunomodulatory agents applied to the toes or toenails: 2 weeks; •Systemic corticosteroids (including intramuscular injections): 4 weeks; •Systemic immunomodulatory agents: 4 weeks; •Systemic antifungals for treatment of onychomycosis or with known activity against dermatophyte: 24 week; 4.Any significant active or past medical condition that, in the investigators’ opinion, may expose the individuals to an unacceptable risk by study participation, confound the evaluation of treatment response or adverse events, or interfere with the individual’s ability to complete the study; 5.Current or past history of psoriasis or lichen planus involving the skin, nails or mucous membranes or any other toenail disease that in the investigators’ opinion may interfere with clinical evaluation of the toenail(s); 6.History of any significant chronic fungal disease other than onychomycosis; 7.Significant peripheral vascular disease or peripheral circulatory impairment, as evidenced by the absence of dorsalis pedis or posterior tibial pulses on either leg based on assessment during the physical exam; 8.History of drug or alcohol abuse (current or within the past 6 months); 9.Participated in any other trial of an investigational drug or device within 30 days prior to screening or participation in a research study concurrent with this study; 10.Current or history of psychiatric disease that would interfere with the ability to comply with the study protocol or the individual judged to be unfit for treatment according to the investigators’ judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effect;Safety evaluations; | — |
Secondary
| Measure | Time frame |
|---|---|
| Onychomycosis Severity Index;Mycological effects; | — |
Countries
china
Contacts
Public ContactHan Ma
Sun Yat-sen University No.5 Hospital
Outcome results
None listed