A study to compare two medicines used to treat fungal infection of nails

To evaluate the comparative efficacy and effectiveness of amorolfine nail lacquer vs clotrimazole lotion in the treatment of onychomycosis-A comparative study - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099059

Enrollment

Registered

2025-12-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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: clotrimazole lotion and oral itraconazole pulse: this is compared to the former Control Intervention1: Amorolfine nail lacquer and oral itraconazole pulse: Participants will be randomiz

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 to 65 years with clinical suspicion of onychomycosis, confirmed by positive KOH mount and/or fungal culture. 2.Patients with distal lateral subungual, superficial white, or proximal subungual onychomycosis 3.Willingness to give informed written consent and comply with study visits and treatment protocol. 4.Both fingernail and toenail involvement considered eligible

Exclusion criteria

Exclusion criteria: 1.History of systemic antifungal therapy or topical antifungal use on affected nails within the past 3 months. 2.Presence of psoriasis, lichen planus, eczema, or other nail disorders that may mimic onychomycosis. 3.Known hypersensitivity or allergic reactions to clotrimazole or ingredients in the nail lacquer or Oral itraconazole. 4.Patients with peripheral vascular disease, diabetes mellitus with complications, or immunocompromised conditions (e.g., HIV). 5.Pregnant or lactating women. 6.Participation in any other investigational drug study within past 30 days.

Design outcomes

Primary

Measure	Time frame
To compare the clinical and mycological efficacy and effectiveness of Amorolfine nail lacquer with Oral itraconazole pulse versus clotrimazole lotion with Oral itraconazole pulse in treating onychomycosisTimepoint: Day 0, 4th week, 8th week, 12th week, 16th week, 20th week, 24th week	—

Secondary

Measure	Time frame
1.To assess the time taken for visible clinical improvement in both treatment groups. 2.To measure patient satisfaction and perceived improvement using a standardized Patient Global Assessment (PtGA) scale. 3.To monitor and compare any adverse effects, both systemic and local, associated with the two treatment approaches. 4.To evaluate treatment adherence and ease of use as reported by patients. Timepoint: Day 0, 4th week, 8th week, 12th week, 16th week, 20th week, 24th week	—

Measure

Time frame

1.To assess the time taken for visible clinical improvement in both treatment groups. 2.To measure patient satisfaction and perceived improvement using a standardized Patient Global Assessment (PtGA) scale. 3.To monitor and compare any adverse effects, both systemic and local, associated with the two treatment approaches. 4.To evaluate treatment adherence and ease of use as reported by patients. Timepoint: Day 0, 4th week, 8th week, 12th week, 16th week, 20th week, 24th week

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Countries

India

Contacts

Public ContactDrKeerthanaKS

Chettinad Hiospital and research institute

hod.dermatology@care.edu.in04447428101

Outcome results

None listed

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