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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

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

Clinicaltrials.gov identifier NCT03923010

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted August 5, 2020

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:Mycoses
  • Intervention/Treatment: Drug: Itraconazole
  • Phase: Phase 4
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 50 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
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: September 2020
  • Estimated Study Completion Date: September 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.
Outcome Measures
  • 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).
Eligibility Criteria
  • Ages Eligible for Study: 18 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

Contacts and Locations
Contacts

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

Locations

India
Post Graduate Institute of Medical Education & Research (PGIMER)
Chandigarh

India
Sri Ramachandra Medical Centre
Chennai

India
Yenepoya Medical College
Mangalore

India
K J Somaiya Medical College
Mumbai

India
Lata Mangeshkar Hospital
Nagpur

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

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

More Information
  • Responsible Party: Janssen Research & Development, LLC
  • ClinicalTrials.gov Identifier: NCT03923010 History of Changes
  • Other Study ID Numbers: CR108518, R051211FUN4058
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: August 5, 2020
  • Last Verified: August 2020
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Mycoses