Isotretinoin Versus Excimer Light an Adjuvant in Treating Onychomycosis

NCT06485505 | Recruiting Phase 1

• 1 other identifier: Onychomycosis
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Itraconazole

ACTIVE COMPARATOR

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 + Low dose Isotretinoin

EXPERIMENTAL

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

Itraconazole +Excimer light

EXPERIMENTAL

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

Interventions

ISOtretinoin 10 MG DRUG

Low dose isotretinoin as an adjuvant for itraconazole in treating onychomycosis

Itraconazole + Low dose Isotretinoin

excimer light DEVICE

excimer light as an adjuvant for itraconazole in treating onychomycosis

Itraconazole +Excimer light

Itraconazole 200 mg DRUG

Itraconazole alone

Itraconazole

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with onychomycosis

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Zagazig, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Onychomycosis

Interventions

Isotretinoin; Itraconazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: July 3, 2024
• Study Start: July 12, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)