Mycoses
Conditions
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.
Interventions
DRUGItraconazole
Participants will receive itraconazole 200 mg orally once daily for 7 days and at the discretion of the treating physician on Day 14. Participants will also get their regular clinical care at the discretion of their treating physician.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Clinical Response | Day 7 (End of Treatment) | Percentage of participants with clinical response will be reported. Assessment of clinical response will be done by using Investigator Global Evaluation tool based on the signs and symptoms and clinical improvement scores. The percentage of clinical improvement will be measured at the score ranging from 1 to 5 where Score 1: Healed (absence of signs and symptoms), Score 2: Markedly improved (greater than \[\>\] 50 percentage \[%\] clinical improvement), Score 3: Considerable residual lesion (less than \[\<\] 50% clinical improvement), Score 4: No change (same as baseline), and Score 5: Worse (deterioration from baseline). Clinical response will be defined as having Scores 1 or 2 (healed or markedly improved). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants who Have Mycological Cure | Day 14 | Percentage of participants who have mycological cure will be reported. Mycological cure is defined as both culture and microscopy negative to causative fungi. |
| Plasma Concentrations of Itraconazole and Hydroxy-Itraconazole | Days 7 and 14: Pre-dose, 2 and 4.5 hours | Plasma concentrations of itraconazole and hydroxy-itraconazole will be measured. |
| Baseline Minimum Inhibitory Concentration (MIC) of Itraconazole | Baseline (Day 0) | Minimum inhibitory concentration of itraconazole toward fungal pathogens will be determined. |
| Percentage of Participants with Clinical Response | Day 14 | Percentage of participants with clinical response will be reported. Assessment of clinical response will be done by using Investigator Global Evaluation tool based on the signs and symptoms and clinical improvement scores. The percentage of clinical improvement will be measured at the score ranging from 1 to 5 where Score 1: Healed (Absence of signs and symptoms), Score 2: Markedly improved (greater than \[\>\] 50 percentage \[%\] clinical improvement), Score 3: Considerable residual lesion (less than \[\<\] 50% clinical improvement), Score 4: No change (same as baseline), and Score 5: Worse (deterioration from baseline). Clinical response will be defined as having Scores 1 or 2 (healed or markedly improved). |
Countries
India
Outcome results
None listed