A study of Q-switched Nd:Yag laser in treatment of onychomycosis.
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Nail clearance 3mm in 12 weeks
Study Overview
Brief Summary
Onychomycosis, worldwide in distribution accounts for approximately 20-40% percent of all nail disorders. Individuals wearing shoes for prolonged durations, those with co morbiditieslike diabetes, peripheral vascular disease, HIV, immunosuppression are moreprone to this infection. Further it serves as a source of infection to selfor others and affects the quality of life by causing disfigurement of the nail,pain and discomfort, physical and occupational limitations resulting in negativeeffect on the social, emotional and occupational functioning of the individualand in severe cases may even lead to depression.
Slow growth of the nail along with increasing resistance to anti fungal drugs makes definitive treatment of this condition challenging. Options include debridementof nail; mechanical and chemical palliative care, oral and topical antifungaldrugs, and their various combinations. Choice of treatment depends upon thedisease severity but is subject to relatively high failure rates, is time consumingand costly.The cure rate is only 40-80% even after several monthsof use of potent systemic antifungals which is worse in face of increasingdermatophyte resistance. Oral medications may be associatedwith side effects like vomiting, constipation, headache, drowsiness and skinrash.
Q switched Nd:Yag laser is now approved for management of onychomycosis, however conflicting reports exist in literature about its efficacy. No reports from India exist in such management.
This study was hence conducted with the aim to studythe efficacy of Q Switched Nd Yag laser management of onychomycosis in comparison toItraconazole which is also approved for dermatophyte onychomycosis and is used as an off-labelindication for non-dermatophyte onychomycosis.
The study was initiated with a Null hypothesis that Q switched Nd Yag Laser is not as effective as capsule Itraconazole in management of onychomycosis.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Confirmed diagnosis of Onychomycosis in either fungal culture or direct microscopy
- •No history of past treatment.
Exclusion Criteria
- •Fungal culture negative/failure to demonstrate fungus on nail KOH mount
- •Periungual bacterial infections, subungual hematoma
- •Associated nail disorders which produce changes in the nail plate like psoriasis, pityriasis rubra pilaris, atopic dermatitis and lichen planus
- •Pregnant women
- •Deranged liver functions.
Outcomes
Primary Outcomes
Nail clearance 3mm in 12 weeks
Time Frame: 0,3 months, 12 months
Secondary Outcomes
- Onychomycosis severity Index(0, 3 months, 12 months)
- Visual Analogue Scale(0,3 months, 12 months)