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

Phase 4 Terminated 40 enrolled Janssen Research & Development, LLC

NaSingle-groupOpen-labelPrevention

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.

Timeline

Start: 2019-08-06
Primary completion: 2020-03-25
Completion: 2020-03-27

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped (Enrollment): “Further recruitment not possible due to COVID 19 impact. Hence a decision to close study was taken by the sponsor in Aug 2020”

paper Clinical response of "healed" or "markedly improved" based on the Investigator Global Evaluation Tool at day 7 (primary objective) was 42.9% PMID 36787305 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Itraconazole	Small molecule	200 mg	Oral