ArticleIndian journal of dermatology
Topical Tofacitinib for Atopic Dermatitis - Outcomes from Randomized Phase 3 Clinical Trial: First Approval.
Article in Indian journal of dermatology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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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.
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.
Who cites it
1 citing paper in PubMed.
- JAK-STAT pathway-associated skin diseases: a refined functional framework for inflammatory skin diseases.Frontiers in immunology · 2026Review
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: The Janus kinase (JAK) enzyme plays a crucial role in the pathophysiology of atopic dermatitis (AD). The United States Food and Drug Administration (USFDA) has recently granted approval for three JAK inhibitors intended for AD treatment. These comprise topical Ruxolitinib, oral Abrocitinib, and Upadacitinib. In alignment with these advancements, we developed a topical formulation of Tofacitinib, a JAK inhibitor, and evaluated its potential in mild-to-moderate AD, which has been recently approved on the basis of a phase 3 clinical trial. Aims and Objectives: The present trial was conducted to evaluate the efficacy and safety of tofacitinib ointment 2% w/w (Tof-O) versus pimecrolimus cream 1% w/w (Pim-C) in adult patients with mild-to-moderate AD. Materials and Methods: In this prospective, open-label, multicenter phase 3 trial, 184 patients with mild-to-moderate AD were randomized (1:1) to receive either Tof-O or Pim-C for 4 weeks. The efficacy evaluations included percent change in Eczema Area and Severity Index (EASI) score, percentage of patients achieving EASI 50, 75, and 90% improvement, change in validated Investigator Global Assessment (vIGA-AD) score, change in affected percentage body surface area (BSA), and change in pruritus using numeric scale. Safety and tolerability were assessed by laboratory parameters, physical examination, and adverse events (AEs). Results: Tof-O significantly (P < 0.05, mean: 1.9709, CI: -4.3327, 8.2745) improved EASI score from baseline after 4 weeks of treatment; the improvement was comparable to Pim-C. Both treatment groups also demonstrated a significant ( Conclusion: Tof-O demonstrated favourable safety and efficacy in mild-to-moderate AD patients following 4 weeks of treatment. Trial Registration: Clinical Trial Registry-India (CTRI). CTRI/2022/07/044136 [Registered on: 19/07/2022] Trial Registered Prospectively. URL: https://ctri.nic.in/Clinicaltrials/showallp.php?mid1=71771&EncHid=&userName=tofacitinib%20ointment. Type of Trial: Interventional.
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