A COMPARATIVE STUDY OF TWO DIFFERENT LASERS IN TREATMENT OF FUNGAL NAIL INFECTION
Phase 3
Completed
- Conditions
- Other nail disorders,
- Registration Number
- CTRI/2020/04/024710
- Lead Sponsor
- COMMAND HOSPITAL
- Brief Summary
study will be comparing the efficacy and side effect profile of Fractional CO2 LASER as compared to ,Nd-YAG LASER which is an accepted modality of treatment for onychomycosis.For the above study three passes of each laser will be given to two different diseased nail on each sitting , and result will be compared after 6weeks, and 16 weeks of treatment
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- a)All consecutive patients over the age of 18 years of either gender reporting to the department of Dermatology, CHAF Bangalore with one or more toenail and/or fingernail fungal infections of the following types: distal subungual onychomycosis, proximal subungual onychomycosis, superficial white or black onychomycosis, mixed patterns or total dystrophic type onychomycosis.
- b)Diagnosis of Onychomycosis confirmed on demonstration of fungal hyphae on direct microscopy or fungal culture.
- c)Subjects should be willing and able to comply with all follow-up requirements d)Not on any medication for past 06 months for Onychomycosis.
Exclusion Criteria
- a)Cases where KOH mount for fungal hyphae and fungal culture are negative.
- b)Patients who were on systemic or topical antifungals in the past three months.
- c)Nail disorders due to psoriasis, chronic eczema, lichen planus, bacterial infections, subungual hematoma, and non-onychomycosis causes of nail dystrophy.
- d)Pregnant and lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TREATMENT OF NAIL FUNGAL INFECTION-l)Follow-up shall be performed at each visit at 4 weeks interval with assessment of clinical improvement using OSI score, photography and patient subjective assessment score. In addition to the above modalities, assessment will be done with mycological cultures and KOH mount after 16 weeks and 6 months from initiation of treatment. Analysis of the data will be carried out at 6 months after initiation of treatment . After 6weeks and 6 month of 1st sitting of laser treatment.
- Secondary Outcome Measures
Name Time Method REDUCTION IN QSI SCORE 16 weeks and 6 months from initiation of treatment
Trial Locations
- Locations (1)
COMMAND HOSPITAL
🇮🇳Bangalore, KARNATAKA, India
COMMAND HOSPITAL🇮🇳Bangalore, KARNATAKA, IndiaDR DEVINDER KUMAR SUHAGPrincipal investigator9650488406devindersuhag@yahoo.com