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

NCT03814343 | Completed Phase 4

• 1 other identifier: 799/2018
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Fungal Infection; Onychomycosis; Fungus, Nail

Keywords

fungal infection; onychomycosis; amphotericin B; Dimethylsulphoxide; non-dermatophyte; randomized double blind controlled trial

Outcome Measures

Primary Outcomes (2)

• Effectiveness of amphotericin B in 30% DMSO solution comparing with 30% DMSO solution in NDMs onychomycosis treatment

  Effectiveness was evaluated by patients who had negative on mycological laboratory (mycological cure) as percentage.

  36 weeks

• Median time to mycological cure of patients with amphotericin B in 30% DMSO solution comparing with 30% DMSO solution in NDMs onychomycosis treatment

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

  36 weeks

Secondary Outcomes (3)

• Clinical cure of amphotericin B in 30% DMSO solution comparing with 30% DMSO solution in NDMs onychomycosis treatment

  36 weeks

• Median time to clinical cure of patients with amphotericin B in 30% DMSO solution comparing with 30% DMSO solution in NDMs onychomycosis treatment

  36 weeks

• Evaluate side effects of amphotericin B in 30% DMSO solution comparing with 30% DMSO solution in NDMs onychomycosis treatment

  12 weeks

Study Arms (2)

Active comparator

ACTIVE COMPARATOR

10 patients with NDMs onychomycosis treated with amphotericin B in 30% DMSO.

Drug: amphotericin B in 30% DMSO

control comparator

PLACEBO COMPARATOR

10 patients with NDMs onychomycosis treated with 30% DMSO.

Drug: 30% DMSO

Interventions

amphotericin B in 30% DMSO DRUG

amphotericin B in 30% DMSO was given to patients in active comparators group for continuous 12 weeks.

Active comparator

30% DMSO DRUG

30% DMSO was given to patients in placebo comparators group for continuous 12 weeks.

control comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with non-dermatophyte onychomycosis.
• Patients aged more than 18 years.
• Patients has not been treated with any oral/ IV/ topical antifungal therapy within 36 weeks before enrolled.

You may not qualify if:

• Patients had concomitant nail diseases.
• Immunocompromised host.
• Patients with dermatophyte onychomycosis.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Department of Dermatology Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (15)

• Butani D, Yewale C, Misra A. Amphotericin B topical microemulsion: formulation, characterization and evaluation. Colloids Surf B Biointerfaces. 2014 Apr 1;116:351-8. doi: 10.1016/j.colsurfb.2014.01.014. Epub 2014 Jan 19.

  PMID: 24521698 BACKGROUND

• Downs AM, Lear JT, Archer CB. Scytalidium hyalinum onychomycosis successfully treated with 5% amorolfine nail lacquer. Br J Dermatol. 1999 Mar;140(3):555. doi: 10.1046/j.1365-2133.1999.02739.x. No abstract available.

  PMID: 10233295 RESULT

• Cursi IB, Silva RT, Succi IB, Bernardes-Engemann AR, Orofino-Costa R. Onychomycosis due to Neoscytalidium treated with oral terbinafine, ciclopirox nail lacquer and nail abrasion: a pilot study of 25 patients. Mycopathologia. 2013 Feb;175(1-2):75-82. doi: 10.1007/s11046-012-9580-5. Epub 2012 Sep 14.

  PMID: 22976905 RESULT

• Tosti A, Piraccini BM, Lorenzi S. Onychomycosis caused by nondermatophytic molds: clinical features and response to treatment of 59 cases. J Am Acad Dermatol. 2000 Feb;42(2 Pt 1):217-24. doi: 10.1016/S0190-9622(00)90129-4.

  PMID: 10642676 RESULT

• Welsh O, Vera-Cabrera L, Welsh E. Onychomycosis. Clin Dermatol. 2010 Mar 4;28(2):151-9. doi: 10.1016/j.clindermatol.2009.12.006.

  PMID: 20347657 RESULT

• Gupta AK, Drummond-Main C, Cooper EA, Brintnell W, Piraccini BM, Tosti A. Systematic review of nondermatophyte mold onychomycosis: diagnosis, clinical types, epidemiology, and treatment. J Am Acad Dermatol. 2012 Mar;66(3):494-502. doi: 10.1016/j.jaad.2011.02.038. Epub 2011 Aug 4.

  PMID: 21820203 RESULT

• Bunyaratavej S, Prasertworonun N, Leeyaphan C, Chaiwanon O, Muanprasat C, Matthapan L. Distinct characteristics of Scytalidium dimidiatum and non-dermatophyte onychomycosis as compared with dermatophyte onychomycosis. J Dermatol. 2015 Mar;42(3):258-62. doi: 10.1111/1346-8138.12768. Epub 2015 Jan 13.

  PMID: 25639524 RESULT

• Bunyaratavej S, Leeyaphan C, Rujitharanawong C, Surawan TM, Muanprasat C, Matthapan L. Efficacy of 5% amorolfine nail lacquer in Neoscytalidium dimidiatum onychomycosis. J Dermatolog Treat. 2016 Aug;27(4):359-63. doi: 10.3109/09546634.2015.1109029. Epub 2015 Nov 11.

  PMID: 26471716 RESULT

• Gupta AK, Paquet M, Simpson FC. Therapies for the treatment of onychomycosis. Clin Dermatol. 2013 Sep-Oct;31(5):544-54. doi: 10.1016/j.clindermatol.2013.06.011.

  PMID: 24079583 RESULT

• Machouart M, Menir P, Helenon R, Quist D, Desbois N. Scytalidium and scytalidiosis: what's new in 2012? J Mycol Med. 2013 Mar;23(1):40-6. doi: 10.1016/j.mycmed.2013.01.002. Epub 2013 Feb 15.

  PMID: 23416171 RESULT

• James JE, Santhanam J, Lee MC, Wong CX, Sabaratnam P, Yusoff H, Tzar MN, Razak MF. In Vitro Antifungal Susceptibility of Neoscytalidium dimidiatum Clinical Isolates from Malaysia. Mycopathologia. 2017 Apr;182(3-4):305-313. doi: 10.1007/s11046-016-0085-5. Epub 2016 Nov 4.

  PMID: 27815659 RESULT

• Lurati M, Baudraz-Rosselet F, Vernez M, Spring P, Bontems O, Fratti M, Monod M. Efficacious treatment of non-dermatophyte mould onychomycosis with topical amphotericin B. Dermatology. 2011;223(4):289-92. doi: 10.1159/000335093. Epub 2012 Jan 10.

  PMID: 22236569 RESULT

• Hussain A, Samad A, Singh SK, Ahsan MN, Haque MW, Faruk A, Ahmed FJ. Nanoemulsion gel-based topical delivery of an antifungal drug: in vitro activity and in vivo evaluation. Drug Deliv. 2016;23(2):642-47. doi: 10.3109/10717544.2014.933284. Epub 2014 Jul 11.

  PMID: 25013957 RESULT

• Zaioncz S, Khalil NM, Mainardes RM. Exploring the Role of Nanoparticles in Amphotericin B Delivery. Curr Pharm Des. 2017;23(3):509-521. doi: 10.2174/1381612822666161027103640.

  PMID: 27799043 RESULT

• Ungpakorn R, Lohaprathan S, Reangchainam S. Prevalence of foot diseases in outpatients attending the Institute of Dermatology, Bangkok, Thailand. Clin Exp Dermatol. 2004 Jan;29(1):87-90. doi: 10.1111/j.1365-2230.2004.01446.x.

  PMID: 14723731 RESULT

MeSH Terms

Conditions

Mycoses; Onychomycosis

Interventions

Amphotericin B; Dimethyl Sulfoxide

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Tinea; Dermatomycoses; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Sulfoxides; Sulfur Compounds

Study Officials

• Sumanas Bunyaratavej, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

• Charussri Leeyaphan, MD

  Mahidol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind controlled trial between participants, drug preparing team, doctors, investigators, and outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double blind controlled trial pilot study

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 24, 2019
• Study Start: January 15, 2019
• Primary Completion: November 15, 2020
• Study Completion: November 30, 2020
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

TH (1)