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A comparative study to ascertain efficacy of oral antifungal therapy and laser in fungal nail infection.

A SINGLE BLIND RANDOMIZED CONTROLLED TRIAL TO COMPARE EFFECTIVENESS OF ORAL ITRACONAZOLE PULSE THERAPY V/S ORAL ITRACONAZOLE PULSE THERAPY PLUS 1064 nm Q-SWITCHED Nd: YAG LASER V/S 1064 nm Q-SWITCHED Nd: YAG LASER FOR THE TREATMENT OF ONYCHOMYCOSIS WITH SPECIES STUDY IN A TERTIARY HEALTH CARE CENTRE

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024536
Enrollment
90
Registered
2020-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: L608- Other nail disorders

Interventions

Intervention1: oral itraconazole pulse therapy: The cases were given oral itraconazole 400 mg daily for the first week only of each month, for 3 months, followed by a drug-free follow-up period of 9 m

Sponsors

Dr Prasenjeet Mohanty
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients having one or more toenail and/or fingernail fungal infections of the following types: distal subungual onychomycosis, proximal subungual onychomycosis, superficial white/black onychomycosis, endonyx onychomycosis, total dystrophic type onychomycosis or mixed onychomycosis. 2. Patients with diabetes mellitus, immunocompromised patients, and organ transplant patients will be included, although we consider that these patient groups success rates could be considerably less.

Exclusion criteria

Exclusion criteria: 1. Patients who used systemic antifungal or isotretinoin within 6months. 2. Permanent or semi-permanent discoloration of the nail plate (e.g. topical therapeutics, cosmetics or professional dye exposure) as they can cause various physiological changes to the nail plate in addition to discoloration. 3. Subungual hematoma, nevoid subungual formation, bacterial nail infections, and concomitant nail disorders such as psoriasis of nail plate, lichen planus and atopic dermatitis. 4. Fungal infections of other body parts. 5. Any generalized skin disease. 6. Pregnancy. 7. Patients having liver or renal disease.

Design outcomes

Primary

MeasureTime frame
% of patients with excellent outcomeTimepoint: December 2019 to December 2020

Secondary

MeasureTime frame
1. Species detection 2. % of incomplete cure and relapse. 3. Safety profile of interventionTimepoint: December 2019 to December 2020

Countries

India

Contacts

Public ContactSiddhartha Dash

S.C.B. Medical College and Hospital

titoon@rediffmail.com7381231102

Outcome results

None listed

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