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A clinical trial to compare the safety and efficacy of laser treatment when compared to oral antifungal therapy in fungal nail infection

A Randomized Control study to compare the safety and efficacy of Q-switched ND-YAG laser in comparison to Itraconazole pulse therapy in treatment of onychomycosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012815
Enrollment
106
Registered
2018-03-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with toe nail onychomycosis

Interventions

Intervention1: Nd:YAG laser: The Q- switched Nd:YAG laser protocol will include 02 sessions at Day 0 and Day 30. Each session will include a total of 02 passes over the nail with a 02 minute waiting

Sponsors

Institutional Research Committee
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Clinically by â??Onychomycosis Severity Index", Confirmed by nail clipping (KOH mount) or culture at 12 weeks. Complete cure is accepted as the combination of mycological and clinical cure. Timepoint: week 0,4,12,52

Secondary

MeasureTime frame
Clear nail growth, erythema, onycholysis will be followed up every week for 01 yearTimepoint: 01 year

Countries

India

Contacts

Public ContactLt Col Vikas Pathania

Armed Forces Medical College

vikascongo@yahoo.co.in9599847519

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026