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| ID | Type | Description | Link |
|---|---|---|---|
| R051211FUN4058 | Other Identifier | Janssen Research & Development, LLC |
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Further recruitment not possible due to COVID 19 impact. Hence a decision to close study was taken by the sponsor in Aug 2020
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Plasma Concentrations of Itraconazole and Hydroxy-Itraconazole |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Post Graduate Institute of Medical Education & Research (PGIMER) | Chandigarh | 160012 | India | |||
| Sri Ramachandra Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36787305 | Derived | 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. |
| Label | URL |
|---|---|
| Itraconazole in the Management of Superficial Fungal Infections in India. A Pilot Study | View source |
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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
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Plasma concentrations of itraconazole and hydroxy-itraconazole will be measured. |
| Days 7 and 14: Pre-dose, 2 and 4.5 hours |
| Baseline Minimum Inhibitory Concentration (MIC) of Itraconazole | Minimum inhibitory concentration of itraconazole toward fungal pathogens will be determined. | Baseline (Day 0) |
| 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 |
| Chennai |
| India |
| Yenepoya Medical College | Mangalore | 575018 | India |
| Lata Mangeshkar Hospital | Nagpur | 440001 | India |
| D010879 |
| Piperazines |