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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00869336
Other study ID # TP-0801
Secondary ID
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


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
See also
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Terminated NCT02842021 - Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis Phase 2
Completed NCT01712360 - Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis Phase 4
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Completed NCT01519752 - A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis Phase 1
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Completed NCT02633813 - BE Study of Naftifine HCL Phase 3
Recruiting NCT00856596 - Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females Phase 3
Completed NCT00768599 - A Study of Econazole Foam 1% in Athlete's Foot Phase 2
Recruiting NCT00233493 - Spread of Dermatophytes Among Families N/A
Completed NCT03897257 - A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis Phase 2
Completed NCT03129321 - Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis Phase 3
Completed NCT02335255 - Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis Phase 1
Withdrawn NCT02606383 - Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis Phase 3