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Topical Amphotericin B in 30% Dimethylsulphoxide in Treating of Non-dermatophytes Onychomycosis (amphotericin)

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ClinicalTrials.gov Identifier: NCT03814343
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief Summary:
The randomized control trial study aimed to evaluate effectiveness and safety of amphotericin B in 30% DMSO solution comparing with 30% DMSO solution in NDMs onychomycosis treatment.

Condition or disease Intervention/treatment Phase
Fungal Infection Onychomycosis Fungus, Nail Drug: amphotericin B in 30% DMSO Drug: 30% DMSO Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized double blind controlled trial pilot study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind controlled trial between participants, drug preparing team, doctors, investigators, and outcome assessors.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active comparator
10 patients with NDMs onychomycosis treated with amphotericin B in 30% DMSO.
Drug: amphotericin B in 30% DMSO
amphotericin B in 30% DMSO was given to patients in active comparators group for continuous 12 weeks.

Placebo Comparator: control comparator
10 patients with NDMs onychomycosis treated with 30% DMSO.
Drug: 30% DMSO
30% DMSO was given to patients in placebo comparators group for continuous 12 weeks.




Primary Outcome Measures :
  1. Effectiveness of amphotericin B in 30% DMSO solution comparing with 30% DMSO solution in NDMs onychomycosis treatment [ Time Frame: 36 weeks ]
    Effectiveness was evaluated by patients who had negative on mycological laboratory (mycological cure) as percentage.

  2. 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 ]
    Median time to mycological cure were defined as time (days, months or years) that had negative on mycological laboratory


Secondary Outcome Measures :
  1. Clinical cure of amphotericin B in 30% DMSO solution comparing with 30% DMSO solution in NDMs onychomycosis treatment [ Time Frame: 36 weeks ]
    Clinical cure was defined as the patients had complete clinical improvement or having <10% nail involvement.

  2. 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 ]
    Median time to clinical cure were defined as time (days, months or years) that had clinical improvement of the affected nails.

  3. Evaluate side effects of amphotericin B in 30% DMSO solution comparing with 30% DMSO solution in NDMs onychomycosis treatment [ Time Frame: 12 weeks ]
    Side effects was assessed by the percentage of patients developed any side effect such as erythema, burning sensation, pain.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03814343


Contacts
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Contact: Charussri Leeyaphan, MD +664194333 charussrilee@gmail.com
Contact: Sumanas Bunyaratavej, MD +664194333 consultskin@yahoo.com

Locations
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Thailand
Department of Dermatology Siriraj Hospital Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Charussri Leeyaphan, MD    6624194333    charussrilee@gmail.com   
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Sumanas Bunyaratavej, MD Mahidol University
Study Director: Charussri Leeyaphan, MD Mahidol University

Publications of Results:

Other Publications:
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT03814343     History of Changes
Other Study ID Numbers: 799/2018
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
fungal infection
onychomycosis
amphotericin B
Dimethylsulphoxide
non-dermatophyte
randomized double blind controlled trial
Additional relevant MeSH terms:
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Mycoses
Onychomycosis
Infection
Tinea
Dermatomycoses
Skin Diseases, Infectious
Nail Diseases
Skin Diseases
Amphotericin B
Liposomal amphotericin B
Dimethyl Sulfoxide
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action