Isotretinoin Versus Excimer Light an Adjuvant in Treating Onychomycosis

Efficacy of Low Dose Isotretinoin Versus Excimer Light as an Adjuvant for Itraconazole in Treatment of Onychomycosis: a Randomized Controlled Trial.

3 groups of patients with onychomycosis will be recruited. Group A will receive itraconazole alone. Group B will receive itraconazole + low dose isotretinoin and group C will be treated with itraconazole + excimer light sessions.

Study Overview

• Status: Recruiting
• Conditions: Onychomycosis
• Intervention / Treatment: Drug: Itraconazole 200 mg; Drug: ISOtretinoin 10 MG; Device: excimer light

Detailed Description

The sample size will be calculated by a statistician based upon the rate of onychomycosis cases attending at the outpatient clinical. 3 equal groups of patients will be included. inclusion criteria include: -definite diagnosis of dermatophyte onychomycosis using KOH examination and a fungal culture - a washout period of at least 1 month of any previous therapy -age> 16 years Exclusion criteria include: -pregnancy and lactation -Any active infection or inflammation in or around the nails other than onychomycosis -patients with liver diseases, heart disease and diabetes

Steps of performance and techniques used:

1. Complete history taking.
2. Detailed local examination:

Local examination will be done for the nail to detect swelling, induration, erythema around the nail, local pain and presence of pus during the sessions.

Patients with proven onychomycosis clinically, dermoscopically and through culture will be included in the study.

The included patients will sign an informed written consent before the beginning of the study, and the study will be done under the approval of the ethical committee for postgraduate studies and research of faculty of Medicine, Zagazig University.

Onychomycosis severity index (OSI) will be used for grading of onychomycosis severity where 0=no onychomycosis,1-5= mild onychomycosis,6- 15=moderate onychomycosis, and 16-35=severe onychomycosis.

The patients will be divided into 3 equal groups:

GROUP 1: (itraconazole group); all patients will be prescribed Itraconazole in the dose of 200mg twice daily for 1 week per month, for 3 consecutive months after screening of complete blood count, liver, and renal function tests. patients were advised to record any side effects.

GROUP 2 : will be given low dose of isotretinoin as an adjuvant to itraconazole in the same previously mentioned protocol.

Treatment protocol consists of low dose isotretinoin 20mg, every other day for a 3- month course. After completion of the course, treating dose of isotretinoin will be maintained for 4-6 weeks to prevent recurrence, and to improve healing. During treatment, an infrequent application of the previous therapies will be permitted.

GROUP 3: will be treated with excimer light as an adjuvant to itraconazole in the same previously mentioned protocol. Nails will be treated with XeCl2 excimer light (Eximal Elite Device).

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Zagazig
    • Zagazig, Zagazig, Egypt, 44519
      • Recruiting
      • Zagazig University Hospitals
      • Contact: mona Elradi, MD; Phone Number: +201067070550; Email: monaelradi@medicine.zu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients with onychomycosis

Exclusion Criteria:

• pregnant and lactating females patients on statin therapy or photosensitizing drugs patients with liver disease, heart disease and diabetes milletus.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Itraconazole; all patients will be prescribed Itraconazole in the dose of 200mg twice daily for 1 week per month, for 3 consecutive months after screening of complete blood count, liver, and renal function tests. patients were advised to record any side effects	Drug: Itraconazole 200 mg; Itraconazole alone
Experimental: Itraconazole + Low dose Isotretinoin; patients will be given low dose of isotretinoin as an adjuvant to itraconazole in the same previously mentioned protocol. Treatment protocol consists of low dose isotretinoin (20mg, every other day for pediatrics) for a 3- month course. After completion of the course, treating dose of isotretinoin was maintained for 4-6 weeks to prevent recurrence, and to improve healing. During treatment, an infrequent application of the previous therapies was permitted.	Drug: ISOtretinoin 10 MG; Low dose isotretinoin as an adjuvant for itraconazole in treating onychomycosis
Experimental: Itraconazole +Excimer light; will be treated with excimer light as an adjuvant to itraconazole in the same previously mentioned protocol. Nails will be treated with XeCl2 excimer light (Eximal Elite Device).	Device: excimer light; excimer light as an adjuvant for itraconazole in treating onychomycosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical improvement	using onychomycosis severity index at baseline, last session and follow up vistis	6 month frame: clinical assessment will be done at first presentation of the patients, monthly during the treatment course, at the last visit and 3 month after stoppage of treatment at the follow up visit in a total span of 6 months
Culture	Fungal culture to detect fungal cause and presence after treatment	6 month frame: Fungal culture will be done at first presentation of the patients, at the last visit and 3 month after stoppage of treatment at the follow up visit in a total span of 6 months

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Nail Diseases; Mycoses; Dermatomycoses; Tinea; Skin and Connective Tissue Diseases; Onychomycosis; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Triazoles; Piperazines; Isotretinoin; Itraconazole
• Other Study ID Numbers: Onychomycosis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No