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Trial record 4 of 14 for:    "Tinea Unguium" | "Amorolfine"

Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment

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ClinicalTrials.gov Identifier: NCT03098342
Recruitment Status : Unknown
Verified February 2017 by Chulalongkorn University.
Recruitment status was:  Not yet recruiting
First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
King Chulalongkorn Memorial Hospital
Information provided by (Responsible Party):
Chulalongkorn University

Brief Summary:

Study centre and address

King Chulalongkorn Memorial Hospital

Primary objective

To compare the efficacy and the safety of methylene blue-mediated photodynamic therapy and 5% amorolfine nail lacquer for toenail onychomycosis in Asians


Condition or disease Intervention/treatment Phase
Onychomycosis of Toenail Procedure: Methylene blue-mediated photodynamic therapy Drug: Amorolfine 5% Nail Lacquer Not Applicable

Detailed Description:

• Research Design

Randomized, single-blind clinical trial

• Research Methodology

Target population

  • 42 Patients, aged between 18-90 years old, with distal and lateral subungual toenail onychomycosis diagnosed clinically and mycologically
  • Patients were recruited from Dermatology clinic, King Chulalongkorn Memorial Hospital

    • Exclusion criteria

      1. Those with nail changes because of skin disease or associated systemic diseases
      2. Those who had previously used anti-fungal medications within 3 months for systemic and 1 month for topical therapy.
    • Methods

      1. Patients will be informed of the details of the study including predicted possible adverse events due to the treatments and primary aids.
      2. They will be included in stratified randomly by poor prognostic factors, then divided into two groups (A: methylene blue-mediated photodynamic therapy (MB-PDT) and B: 5% Amorolfine Nail Lacquer by block randomization of size 4 and 6.
      3. For 24 weeks,
  • Group A

    • The use of PDT consisting of 6 treatment sessions with interval of 15 days between each session
    • Patient will be instructed that apply 40% urea cream under occlusive dressing for 5 days prior to PDT.
  • Group B

    • Patients will be detailed instruction regarding the use of 5% Amorolfine Nail Lacquer as its recommended protocol.
    • Total duration of the follow-up is 18 months

Evaluation tool

  • Nail photographs by using dermoscope for onychomycosis severity index (OSI) evaluation
  • Either Scrape or nail clipping, which is positive prior to the treatment, will be performed for microscopic study and culture.
  • Safety will be assessed through adverse events.
  • Patients' satisfaction will be evaluated at the end of the treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment in Asians
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MB-PDT for Onychomycosis Procedure: Methylene blue-mediated photodynamic therapy
Using the 2% MB aqueous solution as a photosensitiser. After the rest period, the lesion was immediately illuminated with incoherent red light (peak emission spectrum at 630-640 nm)
Other Names:
  • Incoherent red light (peak emission spectrum at 630-640 nm)
  • Methylene blue

Active Comparator: Amorolfine for Onychomycosis Drug: Amorolfine 5% Nail Lacquer
Patients will be detailed instruction regarding the use of 5% Amorofine Nail Lacquer (Loceryl®) as its recommended protocol.




Primary Outcome Measures :
  1. Onychomycosis severity index (OSI) [ Time Frame: Change from baseline Onychomycosis severity index at every 2 weeks through the MB-PDT treatment completion, 12 weeks; then change from baseline Onychomycosis severity index at every 8 weeks through the study completion, an average of 18 months. ]
    Photographs taken by using a dermoscope were evaluated by two independent dermatologists.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients, aged between 18-90 years old, with distal and lateral subungual toenail onychomycosis diagnosed clinically and mycologically

    • Clinical signs of onychomycosis as following:

      • Discoloration
      • Dystrophy of nail plate
      • Subungual hyperkeratosis
      • Onycholysis
    • Confirmed by:

      • Positive culture of dermatophyte or non-dermatophyte (must be isolated from sequential specimens) and/or
      • Positive microscopic evidence*
    • *any of these methods, direct microscopy (KOH preparation), nail plate culture on Sabouraud's dextrose agar (SDA), histopathological examination of nail clippings using PAS staining (HPE-PAS), histopathological examination of nail clippings using GMS staining (HPE-GMS), polymerase chain reaction

Exclusion Criteria:

  • Those with nail changes because of skin disease or associated systemic diseases
  • Pregnancy or lactating woman
  • Those who are allergic to amorolfine, methylene blue
  • Those who are photosensitive to visible light
  • Those who had previously used anti-fungal medications within 3 months for systemic and 1 month for topical therapy.

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): NCT03098342


Contacts
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Contact: Einapak Amnarttrakul, MD 7521182743 einapak.b@chula.ac.th
Contact: Pravit Asawanonda, MD, PhD 66818129393 pravit.a@chula.ac.th, fibrosis@gmail.com

Locations
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Thailand
King Chulalongkorn Memorial Hospital Not yet recruiting
Bangkok, Thailand, 10330
Contact: Nutthamon Bowornsathitchai, M.D.    66818239488    bee_o_bo@hotmail.com   
Contact: Jaruwan Pemcharoen, B.Sc.    66823573912    photochulateam@gmail.com   
Sub-Investigator: Anukorn Sriaram, B.Eng.         
Sponsors and Collaborators
Chulalongkorn University
King Chulalongkorn Memorial Hospital
Investigators
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Principal Investigator: Natthamon Bowornsathitchai, MD Chulalongkorn University

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Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03098342     History of Changes
Other Study ID Numbers: CU_MBPDT_for_Onychomycosis
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: February 2017
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Chulalongkorn University:
Onychomycosis
photodynamic therapy
methylene blue
amorolfine, nail lacquer
Asians
Additional relevant MeSH terms:
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Onychomycosis
Amorolfine
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents