A clinical Trial in patients with Tinea pedis and Tinea cruris. Clinical trial is to study efficacy, safety and tolerability of Naftifine Hydrochloride 1% cream in comparison to Terbinafine Hydrochloride 1% cream (reference product).

A Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Naftifine Hydrochloride 1% cream Vs. Terbinafine Hydrochloride 1% cream in patients with Tinea pedis and Tinea cruris.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/001025

Enrollment

200

Registered

2009-12-14

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: L989- Disorder of the skin and subcutaneous tissue, unspecified Health Condition 2: null- Tinea pedis and Tinea cruris infection

Interventions

Intervention1: Naftifine Hydrochloride 1% cream: Twice a day, in the morning and evening for 28 days Control Intervention1: Terbinafine Hydrochloride 1% cream: Twice a day, in the morning and evening

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males and female patients with age 18 to 70 years. 2. Clinical diagnosis of Tinea pedis and Tinea cruris confirmed by laboratory evaluation (microscopic examination confirmed by a positive potassium hydroxide test). 3. Written informed consent by patient. 4. Patient willing to follow up.

Exclusion criteria

Exclusion criteria: 1. Pregnant or nursing females. 2. Patients suffering from onchomycosis, candidiasis, pityriasis versicolor or tinea capitis. 3. Patients with severe chronic diseases. 4. Hypersensitivity to components of Niftifine such as benzyl alcohol,cetyl alcohol ,cetyl esters wax,isopropyl myristate,polysorbat 60,sodium hydroxide,sorbitan monostearate etc. 5. Patients who might have required concomitant medication with other antimycotics administered by another route.

Design outcomes

Primary

Measure	Time frame
Itching, Erythema, Scaling/Crusting, Vesicles and papulesTimepoint: Day 0, Day 7,Day 14 and Day 28.	—

Secondary

Measure	Time frame
Overall response by mycological assessment (KOH mount)Timepoint: Day 0 and Day 28;Patients and physicians Global Assessment of treatment efficacy and tolerabilityTimepoint: Day 28	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shaileshs@ajantapharma.com022-66062112

Outcome results

None listed

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