Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis

Onychomycosis Clinical Trial

Official title:

A Phase 1/2a, Open-Label Study Evaluating the Pharmacokinetics, Safety and Tolerability of Luliconazole Solution, 10% in Subjects With Moderate to Severe Distal Subungual Onychomycosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044381
• Other study ID #: TP-0901-S
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 4, 2010
• Last updated: November 13, 2014
• Start date: December 2010
• Est. completion date: May 2011

Study information

• Verified date: November 2014
• Source: Topica Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine the safety, tolerability, systemic exposure and pharmacokinetics of luliconazole after repeat daily topical application of Luliconazole Solution, 10% in a maximal use setting in adults with distal subungual onychomycosis of the toenails.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 years

• Distal Subungual Onychomycosis(DSO)on both great toenails with >=50%involvement of at least 1 great toenail

• At least 4 additional toenails with DSO

• Positive KOH and culture

• Normal renal and hepatic function

Exclusion Criteria:

• Subjects with hypersensitivity to imidazole compounds or any other ingredient

• Subjects unwilling to refrain from use of nail cosmetics until end of study

• Subjects with symptomatic tinea pedis

• Subjects with any history of cardiac disease of cardiac rhythm abnormalities

• Female subjects who are pregnant, nursing, or planning a pregnancy

• Subjects who have not undergone the specified washout period(s) for the following or requiring the concurrent use of: topical antifungal within 4 weeks; topical anti-inflammatory, corticosteroids, topical immunomodulators within 2 weeks; systemic corticosteroids within 2 weeks; systemic immunomodulators within 4 weeks.

• Subjects receiving systemic antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophytes within the previous 12 weeks or 5 half-lives of the drug, whichever is longer

• Subjects receiving any other treatment/therapy for the onychomycosis not previously mentioned (e.g., laser treatment) within 4 weeks

• Subjects with a history of significant internal disease or with a life threatening condition within the last 6 months

• Subjects with anatomic abnormalities of the toe(s) and or toenails

• Subject who have donated or lost a large volume of blood (~500 mL or more, during the previous 6 weeks

• Subjects with a recent history of or currently known to abuse drugs or alcohol

• Subjects currently participating in another investigational medication or device study or have participated in a clinical trial within 30 days or five half-lives of the test medication

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• Luliconazole Solution, 10%
28 days of daily application

Locations

Country	Name	City	State
United States	J&S Studies	College Station	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Topica Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters (AUC, Cmax, Tmax, t1/2) will be measured at days 1 (Baseline), 9, 15 and 29. Safety assessments include monitoring of adverse events, local site tolerability, ECG monitoring, and changes in laboratory values and vital signs.		March 2011	No
Secondary	Evaluation of linear toenail growth.		March 2011	No