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

Mycoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03923010
• Other study ID #: CR108518
• Secondary ID: R051211FUN4058
• Status: Terminated
• Phase: Phase 4
• Start date: August 6, 2019
• Est. completion date: March 27, 2020

Study information

• Verified date: August 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: March 27, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Mycoses

Intervention

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.

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education & Research (PGIMER)	Chandigarh
India	Sri Ramachandra Medical Centre	Chennai
India	Yenepoya Medical College	Mangalore
India	Lata Mangeshkar Hospital	Nagpur

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day 14
Secondary	Plasma Concentrations of Itraconazole and Hydroxy-Itraconazole	Plasma concentrations of itraconazole and hydroxy-itraconazole will be measured.	Days 7 and 14: Pre-dose, 2 and 4.5 hours
Secondary	Baseline Minimum Inhibitory Concentration (MIC) of Itraconazole	Minimum inhibitory concentration of itraconazole toward fungal pathogens will be determined.	Baseline (Day 0)
Secondary	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 14

External Links

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