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

Primary Purpose

Mycoses

Status
Terminated
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Itraconazole
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mycoses

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Post Graduate Institute of Medical Education & Research (PGIMER)
  • Sri Ramachandra Medical Centre
  • Yenepoya Medical College
  • Lata Mangeshkar Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Itraconazole

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Participants with Clinical Response
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

Percentage of Participants who Have Mycological Cure
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
Plasma concentrations of itraconazole and hydroxy-itraconazole will be measured.
Baseline Minimum Inhibitory Concentration (MIC) of Itraconazole
Minimum inhibitory concentration of itraconazole toward fungal pathogens will be determined.
Percentage of Participants with Clinical Response
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).

Full Information

First Posted
April 18, 2019
Last Updated
August 27, 2021
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03923010
Brief Title
A Study of Itraconazole in the Management of Superficial Fungal Infections in India
Official Title
Itraconazole in the Management of Superficial Fungal Infections in India. A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Further recruitment not possible due to COVID 19 impact. Hence a decision to close study was taken by the sponsor in Aug 2020
Study Start Date
August 6, 2019 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
March 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycoses

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Itraconazole
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Itraconazole
Other Intervention Name(s)
JNJ-16269994
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants with Clinical Response
Description
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).
Time Frame
Day 7 (End of Treatment)
Secondary Outcome Measure Information:
Title
Percentage of Participants who Have Mycological Cure
Description
Percentage of participants who have mycological cure will be reported. Mycological cure is defined as both culture and microscopy negative to causative fungi.
Time Frame
Day 14
Title
Plasma Concentrations of Itraconazole and Hydroxy-Itraconazole
Description
Plasma concentrations of itraconazole and hydroxy-itraconazole will be measured.
Time Frame
Days 7 and 14: Pre-dose, 2 and 4.5 hours
Title
Baseline Minimum Inhibitory Concentration (MIC) of Itraconazole
Description
Minimum inhibitory concentration of itraconazole toward fungal pathogens will be determined.
Time Frame
Baseline (Day 0)
Title
Percentage of Participants with Clinical Response
Description
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).
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Post Graduate Institute of Medical Education & Research (PGIMER)
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Sri Ramachandra Medical Centre
City
Chennai
Country
India
Facility Name
Yenepoya Medical College
City
Mangalore
ZIP/Postal Code
575018
Country
India
Facility Name
Lata Mangeshkar Hospital
City
Nagpur
ZIP/Postal Code
440001
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&amp;parentIdentifier=CR108518&amp;attachmentIdentifier=6ff38044-aee3-45d2-80df-d52197752d2a&amp;fileName=CR108518_CSR-Synopsis.pdf&amp;versionIdentifier=
Description
Itraconazole in the Management of Superficial Fungal Infections in India. A Pilot Study

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

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