Clinical trial NCT03923010: A Study of Itraconazole in the Management of Superficial Fungal Infections in India
Official title: Itraconazole in the Management of Superficial Fungal Infections in India. A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Mycoses
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants with Clinical Response
timeFrame: Day 7 (End of Treatment)
Secondary outcomes:
measure: Percentage of Participants who Have Mycological Cure
timeFrame: Day 14
measure: Plasma Concentrations of Itraconazole and Hydroxy-Itraconazole
timeFrame: Days 7 and 14: Pre-dose, 2 and 4.5 hours
measure: Baseline Minimum Inhibitory Concentration (MIC) of Itraconazole
timeFrame: Baseline (Day 0)
measure: Percentage of Participants with Clinical Response
timeFrame: Day 14
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education & Research (PGIMER)
city: Chennai
country: India
facility: Sri Ramachandra Medical Centre
city: Mangalore
country: India
facility: Yenepoya Medical College
city: Nagpur
country: India
facility: Lata Mangeshkar Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: