A Study of Itraconazole in the Management of Superficial Fungal Infections in India

• Status: Terminated
• Trial end date: 2020-03-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to estimate the proportion of participants prescribed itraconazole for Tinea cruris or Tinea corporis who have clinical response after 7 days of treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

Inclusion Criteria:

• Clinically diagnosed with Tinea cruris or Tinea corporis with or without history of treatment

• Are prescribed itraconazole at 200 milligram/day orally for the treatment of T. cruris or T. corporis and taken once a day

• A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin [beta hCG]) at screening on Day -3 to 0 before start of study drug

• A woman must be (a) not of childbearing potential (b) of childbearing potential and:

Practicing a highly effective method of contraception (failure rate of less than [<] 1 percentage [%] per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study drug and until 30 days after last dose (that is, the end of relevant systemic exposure)

• A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last dose of study drug

Exclusion Criteria:

• History of ventricular dysfunction such as congestive heart failure (CHF) or receiving treatment for CHF, liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances at any time prior to the start of study

• Known achlorhydria or on treatment of gastric acidity

• Presence of other dermatoses, example. psoriasis, seborrhoeic or atopic dermatitis

• Infected with organism with known or established resistance to itraconazole

• Co-existing fungal infection of other body area