NCT00869336

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

June 21, 2011

Status Verified

June 1, 2011

Enrollment Period

6 months

First QC Date

March 25, 2009

Last Update Submit

June 6, 2011

Conditions

Tinea Pedis

Keywords

Tinea PedisAthlete's Foot

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects who achieve complete clearance at 2 weeks post treatment

    Two weeks post treatment

Secondary Outcomes (1)

  • Proportion of subjects who achieve effective treatment at 2 and 4 weeks post treatment

    2 and 4 weeks post treatment

Study Arms (4)

Luliconazole Cream 1% - 2 wks

EXPERIMENTAL

Daily treatment with Luliconazole Cream 1% for 2 weeks

Drug: Luliconazole Cream 1% - 2 wks

Luliconazole Cream 1% - 4 wks

EXPERIMENTAL

Daily treatment with Luliconazole Cream 1% for 4 weeks

Drug: Luliconazole Cream 1% - 4 wks

Placebo Comparator - 2 wks

PLACEBO COMPARATOR

Daily treatment with Vehicle Cream for 2 weeks

Drug: Placebo Comparator -2 wks

Placebo Comparator - 4 wks

PLACEBO COMPARATOR

Daily treatment with Vehicle Cream for 4 weeks

Drug: Placebo Comparator - 4 wks

Interventions

Luliconazole Cream 1% - 2 wksDRUG

Topical cream applied daily for 2 weeks

Luliconazole Cream 1% - 2 wks
Placebo Comparator -2 wksDRUG

Placebo cream applied daily for 2 weeks

Placebo Comparator - 2 wks
Luliconazole Cream 1% - 4 wksDRUG

Topical cream applied daily for 4 weeks

Luliconazole Cream 1% - 4 wks
Placebo Comparator - 4 wksDRUG

Placebo cream applied daily for 4 weeks

Placebo Comparator - 4 wks

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects of either gender must be 12 years of age or older.
  • 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.
  • Subjects with a mycological diagnosis of interdigital tinea pedis confirmed by the detection of fungal hyphae on a microscopic KOH wet mount
  • Females of child-bearing potential must have a negative urine pregnancy test and must agree to use an effective form of contraception

You may not qualify if:

  • 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;
  • Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
  • Subjects who are immunocompromised (due to disease, e.g., HIV or medications
  • Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the cream;
  • Subjects with a life-threatening condition (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
  • Subjects using the following medications:
  • topical antifungal agent within 30 days of the baseline visit
  • systemic antifungals within 8 weeks of the baseline visit (8 months for oral terbinafine)
  • topical corticosteroid in treatment area(s) within 30 days of the baseline visit.
  • systemic corticosteroids within 30 days of the baseline visit;
  • any other topical medicated topical treatments to the treatment area(s) within 7 days of baseline visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Fridley, Minnesota, 55432, United States

Location

Unknown Facility

Portland, Oregon, 97210, United States

Location

Unknown Facility

Austin, Texas, 78759, United States

Location

Unknown Facility

College Station, Texas, 77840, United States

Location

MeSH Terms

Conditions

Tinea Pedis

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousFoot DermatosesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPruritusSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

March 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

June 21, 2011

Record last verified: 2011-06

Locations

US(4)