Evidence map›Paper›PMID 34611418›Full record

ArticleClinical, cosmetic and investigational dermatology2021

An Open-Label, Randomized, Double-Arm Clinical Trial to Compare the Effectiveness and Safety of Super Bioavailable Itraconazole Capsules and Itraconazole Capsules in the Management of Dermatophytosis in India.

Manjunath Shenoy, Dhiraj Dhoot, Harshal Mahajan, Hanmant Barkate

Open access · goldAbstract read
In one paragraph

Article in Clinical, cosmetic and investigational dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 16 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Manjunath ShenoyDepartment of Dermatology, Yenepoya Medical College, Deralakatte, Mangalore, India.
Dhiraj DhootGlobal Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, India.ORCID 0000-0002-2045-9324
Harshal MahajanGlobal Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, India.
Hanmant BarkateGlobal Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, India.
Glenmark Pharmaceuticals (India) · INYenepoya University · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeA new oral formulation of itraconazole, called super bioavailable itraconazole (SBITZ), has been launched in India, exhibiting greater bioavailability than conventional itraconazole (CITZ). No clinical studies on its effectiveness and safety in dermatophytosis in comparison with CITZ have been conducted in India. Hence, the aim of this clinical study was to compare the effectiveness and safety of SBITZ capsules and CITZ capsules in dermatophytosis. PATIENTS AND

methodsThis was an open-label, randomized, double-arm clinical study in which 70 patients (≥18 years of age) of either gender and diagnosed with tinea cruris, tinea corporis, and/or tinea faciei were included. The study was divided into two parts, the first part comprising a treatment period of 4 weeks and the second part an observation period for recurrence, comprised of another 4 weeks, thus making an entire study duration of 8 weeks.

resultsOf the 70 patients enrolled in this study, 59 (33 patients in the CITZ group and 26 patients in the SBITZ group) were included in the final analysis. In both groups, most patients were diagnosed with tinea cruris et corporis, with five or more lesions. At week 4, 11 patients (33.33%) and 17 patients (65.38%) had achieved complete cure (

conclusionIn the light of real-world evidence on effectiveness and safety, SBITZ should be considered as a potent therapeutic choice to effectively control the current menace of dermatophytosis in India.

Indexed as

conventional itraconazoledermatophytosisIndiasuper bioavailable itraconazole

Identifiers

PMID34611418
PMCPMC8485852
OpenAlexW3202329215

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.