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Comparison between treatment of fungal infection of nail by laser and surgery

Not yet recruiting
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
Inclusion Criteria
  1. Presence of fungus in nail clipping demonstrated by KOH/fungal culture 2) Dermoscopic findings suggestive of Onychomycosis.
Exclusion Criteria
  1. 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
NameTimeMethod
1) Clinical cure rate by nail examination and photographic evaluationAt baseline and at the end of 6 months (for finger nails) and 9 months (for toe nails)
2) Mycological cure rate by KOH microscopic examinationAt 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
NameTimeMethod
1) To study adverse drug reactions due to topical and oral antifungal agents2) 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, India
Dr Drishti Rajde
Principal investigator
9978926129
drdrishtirajde@gmail.com

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