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A comparison between the efficacy and tolerability of topical sertaconazole and topical terbinafine in localized fungal infections of the skin

Efficacy and tolerability of topical sertaconazole versus topical terbinafine in localized dermatophytosis: a comparative study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/09/005029
Enrollment
194
Registered
2014-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Localized epidermal dermatophytosis (epidermomycosis)

Interventions

Intervention1: Sertaconazole (2%) cream: Sertaconazole (2%) cream to be applied locally once daily for 4 weeks Control Intervention1: Terbinafine (1%) cream: Terbinafine (1%) cream to be applied local

Sponsors

R G Kar Medical College and Hospital Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18-65 years 2. Patients of both sexes 3. Patients capable of giving informed consent 4. Patients with localized epidermal dermatophytosis confirmed by presence of fungal hyphae in KOH (potassium hydroxide) preparation of skin scrapings from over the lesion at baseline visit

Exclusion criteria

Exclusion criteria: 1. Patients with underlying immunosuppression 2. Pregnant or lactating women 3. Secondarily infected or eczematized lesions 4. Lesions over multiple anatomical regions 5. Lesions with nail or scalp involvement 6. Patients who received any type of anti-fungal therapy within 30 days prior to baseline visit 7. Patients who applied any other topical agent over the lesions prior to baseline visit 8. Patients incapable of understanding the protocol

Design outcomes

Primary

MeasureTime frame
1. "Complete clinical cure" defined as complete absence of erythema, scaling and pruritus and overall global assessment. 2. "Mycological cure" defined as absence of fungal hyphae in KOH preparation of skin scrapings from over the lesion.Timepoint: 2 and 4 weeks after randomization

Secondary

MeasureTime frame
Local adverse effects such as dryness, irritation, eczema, tenderness.Timepoint: 2 and 4 weeks after randomization;Scores of erythema, pruritus, scalingTimepoint: baseline, 2 and 4 weeks after randomization

Countries

India

Contacts

Public ContactDattatreyo Chatterjee

R G Kar Medical College and Hospital Kolkata

dr_skghosh@yahoo.co.in09434401290

Outcome results

None listed

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