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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03098342
Other study ID # CU_MBPDT_for_Onychomycosis
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 20, 2017
Last updated March 27, 2017
Start date June 1, 2017
Est. completion date January 31, 2019

Study information

Verified date February 2017
Source Chulalongkorn University
Contact Einapak Amnarttrakul, MD
Phone 7521182743
Email einapak.b@chula.ac.th
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 42
Est. completion date January 31, 2019
Est. primary completion date December 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Thailand King Chulalongkorn Memorial Hospital Bangkok

Sponsors (2)

Lead Sponsor Collaborator
Chulalongkorn University King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Onychomycosis severity index (OSI) Photographs taken by using a dermoscope were evaluated by two independent dermatologists. 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.
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