A clinical trial to compare the safety and efficacy of laser treatment when compared to oral antifungal therapy in fungal nail infectio
- Conditions
- Health Condition 1: null- Patients with toe nail onychomycosis
- Registration Number
- CTRI/2018/03/012815
- Lead Sponsor
- Institutional Research Committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Males and females between the ages of 18 years and 70 years
2. Confirmed diagnosis using fungal culture and/or direct microscopy
3. Patient with one or more toenail fungal infections of any of the following types:
a) distal subungual onychomycosis
b) proximal subungual onychomycosis
c) superficial white onychomycosis
d) total dystrophic type onychomycosis.
1. Fungal culture negative/ Failure to demonstrate fungus on nail KOH mount
2. Those patients who used systemic or topical antifungal in the past three months of the first scheduled laser session
3. Following conditions:
a) bacterial infections
b) subungual hematoma
c) associated nail disorders which produce changes in the nail plate like psoriasis, atopic dermatitis, lichen planus
4. Pregnant women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinically by â??Onychomycosis Severity Index, <br/ ><br>Confirmed by nail clipping (KOH mount) or culture at 12 weeks. Complete cure is accepted as the combination of mycological and clinical cure. <br/ ><br>Timepoint: week 0,4,12,52
- Secondary Outcome Measures
Name Time Method Clear nail growth, erythema, onycholysis will be followed up every week for 01 yearTimepoint: 01 year