Itraconazole in the Management of Superficial Fungal Infections in India. A Pilot Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- Percentage of Participants with Clinical Response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Itraconazole
Participants with Tinea cruris or Tinea corporis infection that have been prescribed itraconazole 200 milligram (mg) daily by their treating physician will be enrolled in this study. 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.
Intervention: Itraconazole (Drug)
Outcomes
Primary Outcomes
Percentage of Participants with Clinical Response
Time Frame: 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 Outcomes
- Baseline Minimum Inhibitory Concentration (MIC) of Itraconazole(Baseline (Day 0))
- Percentage of Participants with Clinical Response(Day 14)
- Percentage of Participants who Have Mycological Cure(Day 14)
- Plasma Concentrations of Itraconazole and Hydroxy-Itraconazole(Days 7 and 14: Pre-dose, 2 and 4.5 hours)