Efficacy and Safety of 1% Terbinafine Film-Forming Solution Single Application versus 1% Clotrimazole Cream Standard Dose in the Treatment of Tinea Pedis in Correctional Setting

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250319015

Enrollment

Registered

2025-03-19

Start date

2025-06-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Tinea Pedis Tinea Pedis, Terbinafine, Clotrimazole, Antifungal Agents, Film-Forming Solutions

Interventions

Dose: A single application of 1% terbinafine film-forming solution (FFS). Duration: One-time application with no repeated dosing. Mode of Administration: Topical application to the affected area of th

Experimental Drug,Experimental Drug

Terbinafine Film Forming Solution,Clotrimazole Cream

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Male or female prisoners aged equal or more than 18 years. 2.Diagnosed with interdigital type tinea pedis or chronic hyperkeratotic (moccasin-type) tinea pedis, with scaling but less than 1 mm thick, based on clinical and laboratory examination. 3.Willing to participate in the study and provide signed informed consent. 4.Able to attend follow-up visits on Day 1, Week 2, Week 6, and Week 12.

Exclusion criteria

Exclusion criteria: 1.Patients with disseminated fungal infections or concurrent non-dermatophyte fungal infections: 1.1Systemic symptoms or abnormal vital signs indicating disseminated fungal infection. 1.2Presence of onychomycosis (fungal nail infection) or fungal infection at other skin sites. 2.Patients requiring oral antifungal treatment due to severe or extensive disease: 2.1Pustular, vesicobullous, or ulcerative tinea pedis with severe symptoms. 2.2Severe chronic hyperkeratotic tinea pedis requiring systemic therapy. 3.Patients with a history of prohibited medication use within the past 3 months, including: 3.1Topical or systemic corticosteroids. 3.2Topical or systemic immunosuppressive agents. 3.3Topical or systemic antifungal medications. 4.Patients with a history of allergy or contraindications to any of the study medications or their components (1% terbinafine film-forming solution or 1% clotrimazole cream). 5.Patients with comorbid conditions that may interfere with the study, including: Diabetes mellitus.

Design outcomes

Primary

Measure	Time frame
Clinical and Mycologic Cure Rate baseline, Week 2, Week 6, Week 12 Infection Rating Scale, KOH exam, fungal culture	—

Secondary

Measure	Time frame
Adverse Events and Safety Profile Throughout the study (up to Week 12) Patient-reported symptoms and investigator-assessed side effects.,Recurrence Rate Week 12 Percentage of patients with returning symptoms and positive mycologic tests after initial cure. ,Patient treatment satisfaction Week 2, Week 6, Week 12 Patient Satisfaction Score,Patient's Quality of Life Week 2, Week 6, Week 12 Dermatology Life Quality Index (DLQI) Score	—

Measure

Time frame

Adverse Events and Safety Profile Throughout the study (up to Week 12) Patient-reported symptoms and investigator-assessed side effects.,Recurrence Rate Week 12 Percentage of patients with returning symptoms and positive mycologic tests after initial cure. ,Patient treatment satisfaction Week 2, Week 6, Week 12 Patient Satisfaction Score,Patient's Quality of Life Week 2, Week 6, Week 12 Dermatology Life Quality Index (DLQI) Score

—

Countries

Thailand

Contacts

Public ContactSalinee Rojhirunsakool

Department of Dermatology, Faculty of Medicine, Srinakharinwirot University

salinee.roj@gmail.com0894159665

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026