Evidence map›Paper›PMID 37125212›Full record

ArticleInfection and drug resistance2023

Comparative Efficacy of Super Bioavailable Itraconazole Capsules 50 mg vs 65 mg Twice Daily in the Management of Glabrous Tinea.

Bela Shah, Deval Mistry, Dharmender Jairam, Kajal Kansara, Rutvi Pandya, Presha Vasani, Dhiraj Dhoot, Namrata Mahadkar, Sumit Bhushan, Hanmant Barkate

Abstract read
In one paragraph

Article in Infection and drug resistance, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Review
  2. Review
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

10 authors.

Bela ShahDepartment of Dermatology, B J Medical College, Civil Hospital, Ahmedabad, Gujarat, India.
Deval MistryMistry Skin Clinic, Ahmedabad, Gujarat, India.
Dharmender JairamDepartment of Dermatology, B J Medical College, Civil Hospital, Ahmedabad, Gujarat, India.ORCID 0000-0001-5217-7762
Kajal KansaraDepartment of Dermatology, B J Medical College, Civil Hospital, Ahmedabad, Gujarat, India.
Rutvi PandyaDepartment of Dermatology, B J Medical College, Civil Hospital, Ahmedabad, Gujarat, India.ORCID 0000-0002-4207-9955
Presha VasaniDepartment of Dermatology, B J Medical College, Civil Hospital, Ahmedabad, Gujarat, India.
Dhiraj DhootDepartment of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, India.ORCID 0000-0002-2045-9324
Namrata MahadkarDepartment of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, India.
Sumit BhushanDepartment of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, India.
Hanmant BarkateDepartment of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Owing to pharmacokinetic challenges of itraconazole, super-bioavailable itraconazole (SB) was developed and recently approved in strengths of 50mg and 65mg. But comparative study was lacking between these two strengths in glabrous tinea (dermatophytosis) management. Hence, this study was planned to compare the efficacy of both these strengths in dermatophytosis. Methods: One hundred eligible patients were enrolled in this prospective, randomized, clinical study during May-2022 to September-2022 at tertiary hospital in Ahmedabad in adults. Efficacy and safety assessments were done at week-3 and 6 with follow up at week-10 for relapse. Primary objective was to assess the proportion of patients achieving complete cure at week-6 following treatment in both the groups. Secondary outcomes compared safety, clinical and mycological cure rates. Results: Of the 100 patients enrolled, 98 patients (50 in SB-50mg and 48 in SB-65mg group) included in the final analysis. At week 6, 20 patients (40%) and 30 patients (62.5%) achieved complete cure (p < 0.05) in SB-50mg and SB-65mg groups, respectively. In completely cured patients, relapse was reported in 3 (15%) and 5 (17%) patients of SB-50mg and SB-65mg groups, respectively (p = 1). A significant difference was noted in clearance of symptoms and lesions in SB-65mg group (p < 0.05). Moreover, similar results were also obtained in sub-group analysis of recalcitrant dermatophytosis. Both the treatments were found to be safe and well tolerated with no discontinuation. Conclusion: Study result concluded the superiority of SB-65mg over SB-50mg in terms of cure rate and resolution of symptoms in dermatophytosis management.

Indexed as

50mg65mgcomparisondermatophytosisefficacysuper-bioavailable itraconazole

Identifiers

PMID37125212
PMCPMC10146068

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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.