Health Condition 1: B351- Tinea unguium
Conditions
Interventions
Intervention1: Fractional CO2 Laser + Ciclopirox 8% nail lacquer: Participants will receive Fractional CO2 laser therapy applied to affected nails at baseline, in addition to daily topical application
Sponsors
Institute of Naval Medicine
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria Age between 18 to 75 years. Involvement of two or more fingernails or toenails. Positive KOH microscopy for fungal elements. Treatment-na ve patients (no prior antifungal treatment for onychomycosis).
Exclusion criteria
Exclusion criteria: Age below 18 years. Involvement of less than two fingernails or toenails. Negative KOH mount for fungal elements. Female subjects who are pregnant, nursing, or planning to become pregnant during the study period. Presence of other conditions causing nail dystrophy such as psoriasis, eczema, lichen planus, or immunodeficiency states (e.g., HIV infection, post-organ transplantation, long-term immunosuppressive therapy, chemotherapy, or radiotherapy). Any significant disease of the hepatic, renal, endocrine (including diabetes mellitus), or immune systems, or other medical conditions which may interfere with or confound study assessments (e.g., pre-existing chronic foot pain, neurologic deficit, or skin disease/injury of the treated foot).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure improvement in nail appearance, reduction in discoloration and thickness, assessed at 12 weeks and 24 weeks. Mycological cure negative KOH microscopy and culture at 12 weeks and 24 weeks.Timepoint: 12 AND 24 WEEKS POST INITIATION OF TREATMENT | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate patient-reported outcomes including pain, discomfort, and cosmetic improvement.Timepoint: 24 WEEKS POST INITIATION OF TREATMENT | — |
Countries
India
Contacts
Public ContactAnkush Kumar Somvanshi
Institute Of Naval Medicine, INHS Asvini
Outcome results
None listed