A study of efficacy of Fractional CO2 Laser along with topical 1% Terbinafine in treatment of onychomycosis

Onychomycosis is fungal infection of the nail apparatus. It can involve either toenails or fingernails. Onychomycosis causes pain, discomfort, and disfigurement and the discolouration of nails which is the most common complaint and may produce serious physical and occupational limitations, as well as affect the quality of life. Present treatment modalities are ineffective in complete clearance or cur of onychomycosis 

The study aims 

·     To objectively assess the efficacy and side effect profile of Fractional CO2 laser   on patients suffering from onychomycosis

·     To review published evidence regarding the effectiveness of laser technologies in the treatment of onychomycosis

·     To formulate guidelines for use of Fractional CO2 laser in onychomycosis if found effective.

1.    MATERIAL

(a)Study Sample Size       - Total sample size is 50 onychomycotic nails of patients presenting with  onychomycosis.

 (b) Study Population        - Patients presenting with onychomycosis at dermatology

department of Command  Hospital  Airforce Bangalore

during the study period.

(c)  Place of Study            - Department of Dermatology, Command  Hospital               A

Air force Bangalore

(d)  Period of Study          - 01 September 2016 to 31 August 2017.

(a)      Inclusioncriteria

1.   Malesand females over the age of 18 years

2.   Patientwith one or more toenail and/or fingernail fungal infections of the followingtypes: distal subungual onychomycosis, proximal subungual onychomycosis,superficial white or black onychomycosis, mixed patterns or total dystrophictype onychomycosis.

3.   Confirmdiagnosis using fungal culture and direct microscopy

 (b)   Exclusion Criteria

1.   Fungalculture negative or no evidence on direct microscopy.

2.   Thosepatients who used systemic or topical antifungal in the past three months ofthe first scheduled laser session to be excluded.

3.   Conditions,like bacterial infections, subungual hematoma, associated nail disorders whichproduce changes in the nail plate like psoriasis, atopic dermatitis, lichenplanus.

4.   Pregnantwomen.

(c) Informed consent will be takenfrom individual   participating in thestudy.

(d) All the cases will be assessed clinically for onychomycosis andobjectively scored using ONYCHOMYCOSIS SEVERITY INDEX (OSI) and further will beconfirmed by nail clipping (KOH mount) and mycotic culture.

(e) Only culture positive cases shall be included in the study.

(f) Treatment- All the infected nails will be treated with fractional CO2laser (CIS Fi, SellasLaser Technology Co) usingpulse energy of 110 mJ, a density of 256 spots/cm2,pulse interval of 0.5 mm, pulse duration of 0.1milliseconds, and a rectangular spot size of 2- to10-mm length and 0.6- to 5-mm breadth. These parameterswere chosen after a pilot study in department withdifferent parameters. 3 passes will be given at the same site in static operating mode over the affected area including 1-mm normal-appearing areas around them. Altogether 4 sessions of laser therapy were given, each at 4-week intervals. Subjectiveevaluation of pain using a visual analogue scale was done during each session. Thepatients were prescribed Topical 1% Terbinafine cream for application over theaffected nails twice daily during the study period.

(g) Follow-up shall be performed at each visit at 4 weeks interval withassessment of clinical improvement using OSI score, photography and patientsubjective assessment sore. After four sessions of LASER treatment in additionto the above modalities assessment will be done with mycological cultures andKOH mount. The patient will again be followed up at 6 months from the initialtreatment.

(h) Adverse effects shall be recorded and all participants will be asked to complete"subjective assessment score" rating their level of satisfaction.

(j) Complete cure is accepted as the combination of mycological and clinicalcure.

(k)  Instructions

-Should not apply moisturiser or any anti-fungal cream other than theprescribed.

-Should not take any oral antifungaldrug.

-Regular follow-up for the treatments

(l) After the trial period of 16 and 24 weeks, the participating patientsanswers the Post- Trial Questionnaire and analysis of the data will be carriedout.

(m) The data will be maintained prospectively in a computerized database,along with hard copies of proformas which will be analyzed using appropriatestatistical techniques.

(n) Side effect, if any due to fractional CO2 laser will be monitored.

(q)Endpoints of Study: Signs and symptoms like Scaling, erythema, and Vesiculareruptions, Fissures, itching or burning will be followed up every week for 16weeks