A comparative study of Fractional CO2 Laser with 1% Terbinafine cream versus Itraconazole in the management of Onychomycosis

Onychomycosis is afungal infection of the nail apparatus. It can involve either toenails orfingernails. Onychomycosis causes pain, discomfort, and disfigurement and thediscoloration of nails which is the most common complaint and may produceserious physical and occupational limitations, as well as affect the quality oflife. Different treatment options are available to treat nail onychomycosisincluding multiple systemic and topical antifungal agents or surgical nailremoval. Long treatment regimens with incomplete cure are some disadvantages ofthe current treatment options. Newer techniques like photodynamic therapy andFractional CO2 lasers are showing promising results.

 This study will becomparing the efficacy and side effect profile of Fractional CO2 LASER ascompared to oral Itraconazole.

 Material and methods

 1. Source of data

a) Study design:Prospective, randomized, interventional study

b) Cases: All consecutivepatients presenting with onychomycosis at dermatology department of CommandHospital (Air Force) Bangalore during the study period reporting to Dermatologydepartment of CHAF Bangalore

c) Duration of study: 18months

d) Sample size: 100patients (50 patients in each arm).

 2. Inclusion criteria

a) All consecutivepatients over the age of 18 years of either gender reporting with one or moretoenail and/or fingernail fungal infections

b) Diagnosis ofOnychomycosis confirmed on demonstration of fungal hyphae on direct microscopyand fungal culture.

c) Subjects should bewilling and able to comply with all follow-up requirements

 3. Exclusion criteria

a) Cases where KOH mountfor fungal hyphae and fungal culture are negative

b) Patients who were onsystemic or topical antifungals in the past three months.

c) Nail disorders due topsoriasis, chronic eczema, lichen planus, bacterial infections, subungualhematoma, and other non-onychomycosis causes of nail dystrophy

d) Pregnant andlactating women

 4. Intervention

a) Informed consent willbe taken from individuals participating in the study.

 b) All the cases will beassessed clinically for onychomycosis and objectively scored usingONYCHOMYCOSIS SEVERITY INDEX(OSI) and further will be confirmed by nailclipping (KOH mount) and mycotic culture.

 c) Only culture positivecases shall be included in the study.

 d) The patients shall berandomized through draw of cards and allocated to either study arm. One studyarm shall include treatment with Fractional CO2 LASER intermittently along withtopical application of 1% Terbinafine cream and the other shall be administeredCapsule Itraconazole.

 e) Pre-treatment- Fortopical anesthesia before laser therapy, EMLA (Lidocaine 7% w/w + Tetracaine 7%w/w) will be applied under occlusion on the infected nail and periungual areafor 45 minutes.

 f) All the infectednails will be treated with fractional CO2 laser using pulse energy of 110 mJ,energy density of 256 spots/cm2, pulse interval of 0.5 mm, pulse duration of0.1 milliseconds, and a rectangular spot size of 2 to 10 mm length and 0.6 to 5mm breadth. 3 passes will be given at the same site in static operating modeover the affected area including 1 mm normal-appearing areas around them.Altogether 4 sessions of laser therapy will be given, each at 4-week intervals.Topical 1% Terbinafine cream will then be applied to the affected nails twicedaily.

 g) Itraconazole shall beadministered in the dose of 200mg twice daily for one week per month for 3months.

 h) Follow-up shall beperformed at each visit at 4 weeks interval with assessment of clinicalimprovement using OSI score, photography and patient subjective assessmentscore. In addition to the above modalities, assessment will be done withmycological cultures and KOH mount after 12 weeks and 6 months from initiationof treatment. Analysis of the data will be carried out at 6 months.

 i) All participants willbe asked to complete "subjective assessment score" rating their levelof satisfaction

 j) Complete cure isaccepted as the combination of both mycological and clinical cure.

 k) Instructions

• Should not apply moisturizer or any other anti-fungalcream.

• Should not take any oral antifungal drug.

• Regular follow-up for the treatments

 l) The data will bemaintained prospectively in a computerized database, along with hard copies ofproformas which will be analyzed using appropriate statistical techniques.

 m) Side effects, if anydue to Fractional CO2 LASER or with oral Itraconazole will be monitored. Signsand symptoms like, erythema, and Vesicular eruptions, Fissures, itching or burningwill be followed up every week for 12 weeks. Liver function tests will be doneevery month in patients taking Itraconazole.