Comparison between treatment of fungal infection of nail by laser and surgery
- Conditions
- Other nail disorders, (2) ICD-10 Condition: O||Medical and Surgical,
- Registration Number
- CTRI/2021/05/033344
- Lead Sponsor
- GCS Medical College Hospital and Research Centre
- Brief Summary
Currently available treatment options for onychomycosis such as topical and systemic antifungals are often of limited efficacy, difficult to administer or associated with relevant side effects. The disease is notoriously difficult to treat due to the deep-seated nature of fungi within the nail plate, prolonged treatment requirements, poor patient adherence and frequent recurrences. Given the poor efficacy of currently available topical and systemic therapies, there is a renewed interest in exploring alternative treatment modalities for onychomycosis.
Aim of the current study is to compare the benefit of adding urea application followed by CO2 laser ablation and nail avulsion as an adjuvant to conventional therapy in treatment of onychomycosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 321
- Presence of fungus in nail clipping demonstrated by KOH/fungal culture 2) Dermoscopic findings suggestive of Onychomycosis.
- Individuals with photosensitive dermatoses 2) Individuals with contraindications to CO2 laser therapy like Isotretinoin use within the previous six months, history of keloid formation or hypertrophic scarring, ongoing ultraviolet exposure, prior radiation therapy to treatment area, collagen vascular disease 3) Individuals with deranged bleeding time, clotting time, PT, APTT 4) Individuals on antiplatelet therapy (Aspirin, clopidogrel, ticagrelor, etc) 5) Pregnant and lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Clinical cure rate by nail examination and photographic evaluation At baseline and at the end of 6 months (for finger nails) and 9 months (for toe nails) 2) Mycological cure rate by KOH microscopic examination At baseline and at the end of 6 months (for finger nails) and 9 months (for toe nails) 3) Change in OSI (onychomycosis severity index score) At baseline and at the end of 6 months (for finger nails) and 9 months (for toe nails)
- Secondary Outcome Measures
Name Time Method 1) To study adverse drug reactions due to topical and oral antifungal agents 2) To study post operative complications after nail avulsion
Trial Locations
- Locations (1)
GCS Medical College, Hospital and Research Centre
🇮🇳Ahmadabad, GUJARAT, India
GCS Medical College, Hospital and Research Centre🇮🇳Ahmadabad, GUJARAT, IndiaDr Drishti RajdePrincipal investigator9978926129drdrishtirajde@gmail.com