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A Study of Itraconazole in the Management of Superficial Fungal Infections in India

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ClinicalTrials.gov Identifier: NCT03923010
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Mycoses Drug: Itraconazole Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Itraconazole in the Management of Superficial Fungal Infections in India. A Pilot Study
Estimated Study Start Date : May 25, 2019
Estimated Primary Completion Date : December 14, 2019
Estimated Study Completion Date : December 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Itraconazole
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.
Other Name: JNJ-16269994




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Percentage of Participants who Have Mycological Cure [ Time Frame: 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.

  2. Plasma Concentrations of Itraconazole and Hydroxy-Itraconazole [ Time Frame: Days 7 and 14: Pre-dose, 2 and 4.5 hours ]
    Plasma concentrations of itraconazole and hydroxy-itraconazole will be measured.

  3. Baseline Minimum Inhibitory Concentration (MIC) of Itraconazole [ Time Frame: Baseline (Day 0) ]
    Minimum inhibitory concentration of itraconazole toward fungal pathogens will be determined.

  4. Percentage of Participants with Clinical Response [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923010


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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India
Post Graduate Institute of Medical Education & Research (PGIMER) Not yet recruiting
Chandigarh, India, 160012
K J Somaiya Medical College Suspended
Mumbai, India, 400 022
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03923010     History of Changes
Other Study ID Numbers: CR108518
R051211FUN4058 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Mycoses
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors