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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Terminated
CT.gov ID
NCT03923010
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
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
Actual Study Start Date :
Aug 6, 2019
Actual Primary Completion Date :
Mar 25, 2020
Actual Study Completion Date :
Mar 27, 2020

Arms and Interventions

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 Names:
  • JNJ-16269994
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with Clinical Response [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 [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 [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 [Baseline (Day 0)]

      Minimum inhibitory concentration of itraconazole toward fungal pathogens will be determined.

    4. Percentage of Participants with Clinical Response [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Post Graduate Institute of Medical Education & Research (PGIMER) Chandigarh India 160012
    2 Sri Ramachandra Medical Centre Chennai India
    3 Yenepoya Medical College Mangalore India 575018
    4 Lata Mangeshkar Hospital Nagpur India 440001

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT03923010
    Other Study ID Numbers:
    • CR108518
    • R051211FUN4058
    First Posted:
    Apr 22, 2019
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 1, 2021