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

NCT03923010 | Terminated Phase 4

• 2 other identifiers: CR108518R051211FUN4058
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Mycoses

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 7 (End of Treatment)

Secondary Outcomes (4)

• Percentage of Participants who Have Mycological Cure

  Day 14

• Plasma Concentrations of Itraconazole and Hydroxy-Itraconazole

  Days 7 and 14: Pre-dose, 2 and 4.5 hours

• Baseline Minimum Inhibitory Concentration (MIC) of Itraconazole

  Baseline (Day 0)

• Percentage of Participants with Clinical Response

  Day 14

Study Arms (1)

Itraconazole

EXPERIMENTAL

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

Interventions

Itraconazole DRUG

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.

Also known as: JNJ-16269994

Itraconazole

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (4)

Post Graduate Institute of Medical Education & Research (PGIMER)

Chandigarh, 160012, India

Location

Sri Ramachandra Medical Centre

Chennai, India

Location

Yenepoya Medical College

Mangalore, 575018, India

Location

Lata Mangeshkar Hospital

Nagpur, 440001, India

Location

Related Publications (1)

• Handa S, Villasis-Keever A, Shenoy M, Anandan S, Bhrushundi M, Garodia N, Fife D, De Doncker P, Shalayda K, Hu P, Fonseca S, Cure-Bolt N. No evidence of resistance to itraconazole in a prospective real-world trial of dermatomycosis in India. PLoS One. 2023 Feb 14;18(2):e0281514. doi: 10.1371/journal.pone.0281514. eCollection 2023.

  PMID: 36787305 DERIVED

Related Links

• Itraconazole in the Management of Superficial Fungal Infections in India. A Pilot Study

MeSH Terms

Conditions

Mycoses

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 22, 2019
• Study Start: August 6, 2019
• Primary Completion: March 25, 2020
• Study Completion: March 27, 2020
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

IN (4)