Health Condition 1: B354- Tinea corporis Health Condition 2: B356- Tinea cruris
Conditions
Interventions
Intervention1: 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
Sponsors
Johnson Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Each potential participant must satisfy all of the following criteria to be enrolled in the study: 1. Clinically diagnosed with T. cruris or T. corporis with or without history of treatment 2. Are prescribed itraconazole at 200 mg/day orally for the treatment of T. cruris or T. corporis and taken once a day 3. 18 to 60 years of age (both inclusive) 4. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study 5. A woman of childbearing potential must have a negative highly sensitive serum (B-human chorionic gonadotropin [B-hCG]) at screening on Day -3 to 0 before start of study drug. 6. A woman must be (as defined in Section 10, Appendix 10.3, Contraceptive Guidance and Collection of Pregnancy Information) a. Not of childbearing potential b. Of childbearing potential and: Practicing a highly effective method of contraception (failure rate of used consistently and correctly) and agrees to remain on a highly effective method while receiving study drug and until 30 days after last dose (ie, the end of relevant systemic exposure). Examples of highly effective methods of contraception are located in Appendix 10.3, Contraceptive and Barrier Guidance and Collection of Pregnancy Information. Typical use failure rates may differ from those when used consistently and correctly 7. 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
Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: 1. History of ventricular dysfunction such as 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 2. Known achlorhydria or on treatment of gastric acidity 3. Presence of other dermatoses, e.g. psoriasis, seborrhoeic or atopic dermatitis 4. Infected with organism with known or established resistance to itraconazole 5. Co-existing fungal infection of other body area 6. Known allergies, hypersensitivity, or intolerance to itraconazole or its excipients or to any other azole. 7. Pregnant, or breastfeeding women 8. Women of childbearing potential not on any effective contraceptive precautions or planning to become pregnant while enrolled in this study or within 2 weeks after the last dose of study drug 9. Taking drugs that are CYP3A4 substrates (see Section 6.5, Concomitant Therapy before the planned first dose of study drug for disallowed therapies) 10. Received oral itraconazole within 14 days before screening 11. Use of other systemic antifungal or corticosteroid therapy unless such therapy has been discontinued for at least 30 days prior to the start of therapy 12. Use of topical antifungal or corticosteroid therapy within 14 days before screening 13. If at criteria of the treating physician there is a proven or suspected infection with Fusarium species, mucorales or other agents considered not susceptible to itraconazole 14. Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the planned first dose of study drug or is currently enrolled in an investigational study 15. Plans to father a child while enrolled in this study or within 2 weeks after the last dose of study drug 16. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Clinical Response Timepoint: Day 7 (End of Treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline Minimum Inhibitory Concentration (MIC) of Itraconazole Timepoint: Baseline (Day 0);Percentage of Participants who Have Mycological Cure Timepoint: Day 14;Plasma Concentrations of Itraconazole and Hydroxy-Itraconazole Timepoint: Days 7 and 14: Pre-dose, 2 and 4.5 hours | — |
Countries
India
Contacts
Public ContactPrashant Desai
Johnson & Johnson Private Limited
Outcome results
None listed