A clinical Trial in-patients with Dermatomycoses.. Clinical trial is to study efficacy, safety and tolerability of Flutrimazole cream in comparison to Terbinafine Hydrochloride cream (reference product).

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000141

Enrollment

200

Registered

2010-02-23

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- Dermatomycoses Health Condition 2: B998- Other infectious disease

Interventions

Intervention1: Flutrimazole 1% cream: Twice Daily for 28 Days Control Intervention1: Terbinafine Hydrochloride 1% cream: Twice daily for 28 Days

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of Dermatomycoses confirmed by laboratory evaluation (microscopic examination confirmed by a positive potassium hydroxide test). 2. Written informed consent by patient. 3. Patient willing to follow up.

Exclusion criteria

Exclusion criteria: 1. Pregnant or nursing females. 2. Patients with severe chronic diseases. 3. Individuals who present a history of hypersensitivity to other antifungal imidazolic, or any of the components of the pharmaceutical form used. 4. Patients who might have required concomitant medication with other antimycotics administered by another route.

Design outcomes

Primary

Measure	Time frame
Ring-like lesion, Scaling, Erythema, Burning, Itching and VesiclesTimepoint: Day 0, Day 7, Day 14 and Day 28.	—

Secondary

Measure	Time frame
Global Assessment of treatmentTimepoint: Day 28;Mycological assessmentTimepoint: Day 0 and Day 28;Safety and TolerabilityTimepoint: Day 0, Day 7, Day 14 and 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