ClinicalTrials.Veeva

Menu

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

T

Topica Pharmaceuticals

Status and phase

Completed
Phase 2
Phase 1

Conditions

Onychomycosis

Treatments

Drug: Luliconazole Solution, 10%

Study type

Interventional

Funder types

Industry

Identifiers

NCT01044381
TP-0901-S

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Luliconazole Solution, 10%
Experimental group
Treatment:
Drug: Luliconazole Solution, 10%

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems