Efficacy of Low Dose Isotretinoin Versus Excimer Light as an Adjuvant for Itraconazole in Treatment of Onychomycosis: a Randomized Controlled Trial.
Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• patients with onychomycosis
Locations
Other Locations
Egypt
Zagazig University Hospitals
RECRUITING
Zagazig
Time Frame
Start Date: 2024-07-12
Estimated Completion Date: 2026-12
Participants
Target number of participants: 36
Treatments
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
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.
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).
Related Therapeutic Areas
Sponsors
Leads: Zagazig University