Isotretinoin Versus Excimer Light an Adjuvant in Treating Onychomycosis

ConditionOnychomycosis

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-60

SponsorZagazig University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with onychomycosis

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

ISOtretinoin 10 MG
Drug
Low dose isotretinoin as an adjuvant for itraconazole in treating onychomycosis
excimer light
Device
excimer light as an adjuvant for itraconazole in treating onychomycosis
Itraconazole 200 mg
Drug
Itraconazole alone

Treatment groups

36 Participants

are divided into 3 treatment groups

Group A: ItraconazoleActive comparator 1 intervention

Group B: Itraconazole + Low dose IsotretinoinExperimental treatment 1 intervention

Group C: Itraconazole +Excimer lightExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Clinical improvement

using onychomycosis severity index at baseline, last session and follow up vistis

Time frame

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

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zagazig University

Lead sponsor

Source ClinicalTrials.gov

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