Amorolfine versus Luliconazole in superficial fungal infection

COMPARISION OF EFFICACY OF LULICONAZOLE 1% W/W Vs AMOROLFINE 0.25% W/W IN THE TREATMENT OF TINEA CRURIS.A SINGLE CENTRE , RANDOMISED , DOUBLE BLIND , NON INFERIORITY STUDY.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/041348

Enrollment

Registered

2022-03-24

Start date

Unknown

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue

Interventions

Intervention1: Amorolfine 0.25% cream: The patients meeting all the inclusion criteria and not meeting any exclusion criteria shall be considered to participate in the study. A detailed history inclu

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients >18 years of age. 2) Tinea cruris affecting

Exclusion criteria

Exclusion criteria: 1. Patients treated with topical or systemic antifungal or any formulation containing antifungals within the last 4 weeks. 2. Pregnant or lactating females. 3. Patients on any immunosuppressive drugs. 4. Coexisting onychomycosis. 5. Patients with known chronic diseases.(Hypertension/Diabetes Mellitus /Tuberculosis/Asthma)

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of Luliconazole 1% w/w vs Amorolfine 0.25% w/w in the treatment of tinea cruris. Erythema,scaling,pruritus and KOH status compared in the first and follow up visit. Erythema and scaling are measured by clinical examination by the assessor and measured in a scale of 0-3.Pruritus is measured in the visual analogue scale. Presence of fungal elements shall be detected by KOH mount(potassium hydroxide mount).Timepoint: At the end of 2 weeks	—

Measure

Time frame

To compare the efficacy of Luliconazole 1% w/w vs Amorolfine 0.25% w/w in the treatment of tinea cruris. Erythema,scaling,pruritus and KOH status compared in the first and follow up visit. Erythema and scaling are measured by clinical examination by the assessor and measured in a scale of 0-3.Pruritus is measured in the visual analogue scale. Presence of fungal elements shall be detected by KOH mount(potassium hydroxide mount).Timepoint: At the end of 2 weeks

—

Secondary

Measure	Time frame
To compare the safety of Luliconazole 1% w/w and Amorolfine 0.25%w/w in the treatment of tinea cruris. The complaints of the patient shall be recorded. Clinically,the site examination will be done to check for any allergic or irritant contact dermatitis or any other adverse reaction.Timepoint: At the end of 2 weeks	—

Countries

India

Contacts

Public ContactAbhipsa Samal

Department of Skin & VD, Institute of Medical Sciences and SUM Hospital

bikashkar@soa.ac.in9937428181

Outcome results

None listed

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