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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 October 2021 |
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Main ID: |
NCT03814343 |
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Date of registration:
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16/01/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Topical Amphotericin B in 30% Dimethylsulphoxide in Treating of Non-dermatophytes Onychomycosis
amphotericin |
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Scientific title:
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Comparison of Effectiveness of Topical Amphotericin B in 30% Dimethylsulphoxide and 30% Dimethylsulphoxide in Treating of Non-dermatophytes Onychomycosis: Randomized Double Blind Controlled Trial Pilot Study |
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Date of first enrolment:
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January 15, 2019 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03814343 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Charussri Leeyaphan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mahidol University |
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Name:
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Sumanas Bunyaratavej, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mahidol University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients with non-dermatophyte onychomycosis.
2. Patients aged more than 18 years.
3. Patients has not been treated with any oral/ IV/ topical antifungal therapy within 36
weeks before enrolled.
Exclusion Criteria:
1. Patients had concomitant nail diseases.
2. Immunocompromised host.
3. Patients with dermatophyte onychomycosis.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Fungus, Nail
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Fungal Infection
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Onychomycosis
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Intervention(s)
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Drug: amphotericin B in 30% DMSO
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Drug: 30% DMSO
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Primary Outcome(s)
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Effectiveness of amphotericin B in 30% DMSO solution comparing with 30% DMSO solution in NDMs onychomycosis treatment
[Time Frame: 36 weeks]
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Median time to mycological cure of patients with amphotericin B in 30% DMSO solution comparing with 30% DMSO solution in NDMs onychomycosis treatment
[Time Frame: 36 weeks]
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Secondary Outcome(s)
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Evaluate side effects of amphotericin B in 30% DMSO solution comparing with 30% DMSO solution in NDMs onychomycosis treatment
[Time Frame: 12 weeks]
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Clinical cure of amphotericin B in 30% DMSO solution comparing with 30% DMSO solution in NDMs onychomycosis treatment
[Time Frame: 36 weeks]
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Median time to clinical cure of patients with amphotericin B in 30% DMSO solution comparing with 30% DMSO solution in NDMs onychomycosis treatment
[Time Frame: 36 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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