A Study of Itraconazole in the Management of Superficial Fungal Infections in India
- Conditions
- Health Condition 1: B354- Tinea corporisHealth Condition 2: B356- Tinea cruris
- Registration Number
- CTRI/2019/06/019547
- Lead Sponsor
- Johnson Johnson Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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 <1% 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 (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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants with Clinical Response <br/ ><br>Timepoint: Day 7 (End of Treatment)
- Secondary Outcome Measures
Name Time Method Baseline Minimum Inhibitory Concentration (MIC) of Itraconazole <br/ ><br>Timepoint: Baseline (Day 0);Percentage of Participants who Have Mycological Cure <br/ ><br>Timepoint: Day 14;Plasma Concentrations of Itraconazole and Hydroxy-Itraconazole <br/ ><br>Timepoint: Days 7 and 14: Pre-dose, 2 and 4.5 hours