Evidence map›Paper›PMID 40913212›Full record

Trial reportDrug delivery and translational research2026

Exploring topical atorvastatin hyalurosomal gel as an adjuvant for reducing systemic corticosteroid dosage: a randomized clinical trial in severe oral lichen planus patients.

Mahitab Elsayed, Aya Essawy, Radwa M Ismail, Yasmine Gamil, Mohamed G Hamed, Dalia Elsabaawy, Eman Abdelhakeem, Doaa Hegazy, Radwa M A Abd-Elal

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug delivery and translational research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

9 authors.

Mahitab ElsayedClinical Pharmacy Department, Faculty of Pharmacy, Modern University for Technology & Information, Cairo, Egypt.
Aya EssawyClinical Pharmacy Department, Faculty of Pharmacy, Modern University for Technology & Information, Cairo, Egypt.
Radwa M IsmailOral Medicine, Periodontology and Oral Diagnosis, College of Oral and Dental Surgery, Misr University for Science and Technology, Cairo, Egypt.
Yasmine GamilDepartment of Oral Medicine and Periodontology, Faculty of Dentistry, Modern University for Technology & Information, Cairo, Egypt.
Mohamed G HamedOtolaryngology, Faculty of Medicine, Helwan University, Cairo, Egypt.
Dalia ElsabaawyClinical Pharmacy Department, Faculty of Pharmacy, Menofia University, Cairo, Egypt.
Eman AbdelhakeemDepartment of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt. eman.abdelhakeem@pharma.cu.edu.eg.ORCID 0000-0001-6077-3441
Doaa HegazyDepartment of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
Radwa M A Abd-ElalPharmaceutics and Drug Manufacturing Department, Faculty of Pharmacy, Modern University for Technology and Information (MTI), Cairo, 11571, Egypt.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Oral lichen planus (OLP) is a chronic inflammatory disorder with limited topical treatment options and long-term corticosteroid dependency. This study investigates a novel atorvastatin-loaded hyalurosomal gel (ATV-Hyalugel) as a topical adjuvant to reduce systemic corticosteroid use in severe OLP. The objective of the study is to develop, optimize, characterize ATV-Hyalugel and evaluate its clinical efficacy in a randomized controlled clinical trial. ATV-loaded hyalurosomes (ATV-HAs) were prepared via thin-film hydration and optimized using an I-optimal mixture design (independent variables: phospholipid, Tween 80, and hyaluronic acid; responses: entrapment efficiency (EE%), particle size (PS), and zeta potential (ZP). The optimal formulation was incorporated into a chitosan gel, which was characterized for its pH, rheological behavior, and in-vitro drug release. Four weeks randomized controlled trial (n = 90) compared: group one received standard prednisolone (40 mg/day) while group two received half-dose prednisolone (20 mg/day) in combination with ATV-Hyalugel (topically, three times daily). Pain and ulcer scores were recorded weekly. Between-group comparisons were performed using the Mann-Whitney U test (non-parametric; α = 0.05), and within-group improvement from baseline to Week 4 was assessed using the Kruskal-Wallis test. Optimized ATV-HAs demonstrated high EE% (79.1 ± 0.4%), uniform PS (221.2 ± 5.1 nm), and stable ZP (-31.6 ± 0.2 mV). ATV-Hyalugel exhibited mucosa-compatible pH (6.48 ± 0.2), pseudoplastic rheology, and a sustained release profile dominated by diffusion-driven kinetics. Clinically, group two achieved therapeutic equivalence to group one by Week 2 (p > 0.05), despite receiving 50% less corticosteroid. Both groups showed significant symptom reduction from baseline to Week four (p < 0.0001, Kruskal-Wallis). No adverse events were reported with ATV-Hyalugel. ATV-Hyalugel enables a 50% corticosteroid dose reduction while maintaining clinical efficacy. Its favorable release kinetics and safety profile support its use as an innovative adjuvant therapy for severe OLP.

Indexed as

Adrenal Cortex HormonesAtorvastatinHyaluronic AcidLichen Planus, OralPrednisoloneAdministration, TopicalAdultAgedChitosanDrug LiberationFemaleGelsHumansMaleMiddle AgedParticle SizeAdrenal Cortex HormonesAtorvastatinChitosanGelsHyaluronic AcidPrednisoloneAtorvastatinClinical studyHyalurosomesI-optimal mixture designOLP

Identifiers

PMID40913212
PMCPMC13038854

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.