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A study to evaluate the efficacy and safety of 3 study drugs in treatment of patients with with any type of eczematous disorder associated with underlying tinea / yeast infection

A Randomized, open label, comparative, parallel group, three-arm study to evaluate the efficacy, safety and tolerability of a combination of clobetasol, neomycin and miconazole versus combination of betamethasone, clotrimazole, neomycin versus combination of betamethasone, gentamicin, miconazole in patients with any type of eczematous disorder associated with underlying tinea / yeast infection

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/09/003000
Enrollment
54
Registered
2012-09-17
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- eczematous disorder with underlying tinea/yeast infection

Interventions

Intervention1: A combination of clobetasol, neomycin and miconazole: combination of clobetasol, neomycin and miconazole ) to be applied twice daily to the affected areas for 1 week Control Interven

Sponsors

Abbott Healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Patients aged 18 years and above diagnosed with any type of eczematous disorder associated presenting clinical features of underlying tinea/yeast infection •Patients who agree to adhere to the study design •Patients who give their consent for participation in this study

Exclusion criteria

Exclusion criteria: •Pregnant or lactating females •Indications for use of systemic therapy •Patients sensitive to corticosteroids •Patients who have immune deficiency, hepatic or renal impairment •Patients who have been on any therapy within 1 month prior to enrollment in the study •Patients who are using any other concomitant therapy

Design outcomes

Primary

MeasureTime frame
â?¢ Improvement in clinical score from baselineTimepoint: Baseline, Day3, Day5 and Day7

Secondary

MeasureTime frame
â?¢ Improvement in scaling and inflammation â?¢ Improvement in burning and itching â?¢ Adverse event assessment â?¢ Acceptability of the treatment â?¢ Tolerance of the treatment â?¢ Global assessment for efficacy by Investigator and Patient â?¢ Global assessment for tolerability by Investigator and Patient Timepoint: Baseline, Day3, Day5 and Day7

Countries

India

Contacts

Public ContactMrManoj Prabhu

Abbott Healthcare Pvt Ltd

manoj.naik@abbott.in022-39536910

Outcome results

None listed

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