Efficacy and safety of fractional CO2 laser with oral superbioavailable itraconazole versus oral superbioavaible itraconazole in treatment of onychomycosis among patients attending tertiary care hospital bhavnagar- a randomized controlled trial

Onychomycosis,a fungal infectionof nail,is a refractory chronic infectious disease.

•It is the mostcommon infectious disorder in adults accounting for upto 50% of allnail diseases.

•It does notonly affect the appearance of affected nail but can also spread to other partsof the body and lead to complications such as cellulitis.

•Laser therapyfor onychomycosis is a newer treatment modality.

•Using theprinciple of selective photothermolysis,lasers have a photothermaleffect on fungi, with chitin augmenting the heating effect.

•Itraconazoleis the first orally bioavailable triazole with broad spectrum antifungalaction.

•Superbioavailable itraconazole has higher bioavailability than conventionalitraconazole and targeted drug release.

•Dermoscopic patternin onychomycosis shows jagged edges with longitudinal streaks and distalirregular termination.

•Traditionaltreatment of onychomycosis comprise of topical,oral,mechanical andchemical therapies.

•Oral superbioavailable itraconazole has low water solubility and high intestinalpermeability which increases the bioavailabilty of the drug.

•Fractional CO2laser with principal of selective photothermolysis can also aid intreatment of onychomycosis.

•There ispaucity of study of CO2 laser in onychomycosis and this study will add to it.

**Study Design:**This study will berandomized comparative double arm study

**StudyPopulation :**All theclinically diagnosed cases of onychomycosis coming to Dermatology OPD of Sir THospital, Bhavnagar from 1 July 2022 To 30 June 2023.

Study Duration: 15months

Duration ofData Collection : 12 months

**Sample size:**Fractional  CO2laser+Oral super bioavailable Itraconazole=163 nails

Oral super bioavailable Itraconazole=163 nails

**Sampling method:**Patients will be randomizedin both the groups by using random number generator  after taking theconsent according to the inclusion and exclusion criteria.

Inclusioncriteria :

•Patients equalor more than 18 years of age, of either gender presenting with one or morefinger nail onychomycosis.

•Exclusioncriteria :

•Pregnant andlactating female

•Patients withother nail disorders due to psoriasis ,chronic eczema ,lichen planus ,bacterialinfection , subungual hematoma.

•Patients whohad used topical and systemic antifungal in the preceding 3 months.

•Patients withSGOT and SGPT more than the normal range.

•Patients withhistory of cardiac disease.