Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)

Tinea Pedis Clinical Trial

Official title:

Phase 2 Study - A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Duration Finding Study Evaluating the Efficacy and Safety of Two Week and Four Week Once Daily Treatment of Luliconazole Cream 1% in Patients With Tinea Pedis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869336
• Other study ID #: TP-0801
• Status: Completed
• Phase: Phase 2
• First received: March 25, 2009
• Last updated: June 6, 2011
• Start date: March 2009
• Est. completion date: September 2009

Study information

• Verified date: June 2011
• Source: Tinea Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To examine the safety and optimal duration of Luliconazole Cream 1% treatments for 14 days or 28 days to achieve "complete clearance" at 2 weeks post treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Subjects of either gender must be 12 years of age or older.

2. Subjects with a clinical diagnosis of interdigital tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling, and mild pruritus) based on signs and symptoms.

3. Subjects with a mycological diagnosis of interdigital tinea pedis confirmed by the detection of fungal hyphae on a microscopic KOH wet mount

4. Females of child-bearing potential must have a negative urine pregnancy test and must agree to use an effective form of contraception

Exclusion Criteria:

1. Subjects with moccasin (dry type) tinea pedis; with concomitant onychomycosis of the fingernails and/or toenails on the evaluated foot, with severe dermatophytoses, a concurrent tinea infection or bacterial skin infection on the evaluated foot;

2. Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.

3. Subjects who are immunocompromised (due to disease, e.g., HIV or medications

4. Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the cream;

5. Subjects with a life-threatening condition (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.

6. Subjects using the following medications:

1. topical antifungal agent within 30 days of the baseline visit

2. systemic antifungals within 8 weeks of the baseline visit (8 months for oral terbinafine)

3. topical corticosteroid in treatment area(s) within 30 days of the baseline visit.

4. systemic corticosteroids within 30 days of the baseline visit;

5. any other topical medicated topical treatments to the treatment area(s) within 7 days of baseline visit.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• Luliconazole Cream 1% - 2 wks
Topical cream applied daily for 2 weeks
• Placebo Comparator -2 wks
Placebo cream applied daily for 2 weeks
• Luliconazole Cream 1% - 4 wks
Topical cream applied daily for 4 weeks
• Placebo Comparator - 4 wks
Placebo cream applied daily for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tinea Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who achieve complete clearance at 2 weeks post treatment		Two weeks post treatment	Yes
Secondary	Proportion of subjects who achieve effective treatment at 2 and 4 weeks post treatment		2 and 4 weeks post treatment	Yes