Evaluation the Topical Apremilast Nanoformulation in Treatment of Localized Plaque Psoriasis

Summary

This study is a comparative randomized clinical trial evaluating the efficacy and safety of topical apremilast nanoemulsion 0.3% in the treatment of localized mild to moderate plaque psoriasis.Clinical efficacy will be assessed using TES score, Physician Global Assessment (PGA), dermoscopy, and patient satisfaction, while safety is monitored through adverse effect reporting. In addition, histopathological and immunohistochemical evaluation of PDE4 expression will be performed before and after treatment to assess tissue-level responses. The study aims to determine whether topical apremilast nano-formulation, alone or combined with corticosteroids, offers an effective and safer alternative to conventional topical therapy, with improved local efficacy and reduced corticosteroid-related adverse effects.

Timeline

Start

2026-05

Primary completion

2027-05

Completion

2028-03

Publications

• Background Delestras S, Roustit M, Bedouch P, Minoves M, Dobremez V, Mazet R, Lehmann A, Baudrant M, Allenet B. Comparison between two generic questionnaires to assess satisfaction with medication in chronic diseases. PLoS One. 2013;8(2):e56247. doi: 10.1371/journal.pone.0056247. Epub 2013 Feb 20.
• Background Nestor MS, Fischer D, Arnold D. Randomized, Investigator-Blinded Study to Compare the Efficacy and Tolerance of a 650-microsecond, 1064-nm YAG Laser to a 308-nm Excimer Laser for the Treatment of Mild to Moderate Psoriasis Vulgaris. J Drugs Dermatol. 2020 Feb 1;19(2):176-183. doi: 10.36849/JDD.2020.4769.
• Background Louden BA, Pearce DJ, Lang W, Feldman SR. A Simplified Psoriasis Area Severity Index (SPASI) for rating psoriasis severity in clinic patients. Dermatol Online J. 2004 Oct 15;10(2):7.
• Background Parmar PK, Bansal AK. Novel nanocrystal-based formulations of apremilast for improved topical delivery. Drug Deliv Transl Res. 2021 Jun;11(3):966-983. doi: 10.1007/s13346-020-00809-1.
• Background Rapalli VK, Tomar Y, Sharma S, Roy A, Singhvi G. Apremilast loaded lyotropic liquid crystalline nanoparticles embedded hydrogel for improved permeation and skin retention: An effective approach for psoriasis treatment. Biomed Pharmacother. 2023 Jun;162:114634. doi: 10.1016/j.biopha.2023.114634. Epub 2023 Apr 3.
• Background Sarango-Granda P, Silva-Abreu M, Calpena AC, Halbaut L, Fabrega MJ, Rodriguez-Lagunas MJ, Diaz-Garrido N, Badia J, Espinoza LC. Apremilast Microemulsion as Topical Therapy for Local Inflammation: Design, Characterization and Efficacy Evaluation. Pharmaceuticals (Basel). 2020 Dec 21;13(12):484. doi: 10.3390/ph13120484.
• Background Papp K, Cather JC, Rosoph L, Sofen H, Langley RG, Matheson RT, Hu C, Day RM. Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial. Lancet. 2012 Aug 25;380(9843):738-46. doi: 10.1016/S0140-6736(12)60642-4. Epub 2012 Jun 29.
• Background Papp K, Reich K, Leonardi CL, Kircik L, Chimenti S, Langley RG, Hu C, Stevens RM, Day RM, Gordon KB, Korman NJ, Griffiths CE. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1). J Am Acad Dermatol. 2015 Jul;73(1):37-49. doi: 10.1016/j.jaad.2015.03.049.
• Background Paul C, Cather J, Gooderham M, Poulin Y, Mrowietz U, Ferrandiz C, Crowley J, Hu C, Stevens RM, Shah K, Day RM, Girolomoni G, Gottlieb AB. Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate-to-severe plaque psoriasis over 52 weeks: a phase III, randomized controlled trial (ESTEEM 2). Br J Dermatol. 2015 Dec;173(6):1387-99. doi: 10.1111/bjd.14164. Epub 2015 Nov 7.
• Background Schafer PH, Parton A, Capone L, Cedzik D, Brady H, Evans JF, Man HW, Muller GW, Stirling DI, Chopra R. Apremilast is a selective PDE4 inhibitor with regulatory effects on innate immunity. Cell Signal. 2014 Sep;26(9):2016-29. doi: 10.1016/j.cellsig.2014.05.014. Epub 2014 May 29.
• Background Ahmed SS, Manchanda Y, De A, Das S, Kumar R. Topical Therapy in Psoriasis. Indian J Dermatol. 2023 Jul-Aug;68(4):437-445. doi: 10.4103/ijd.ijd_422_23.
• Background Chan JJ. Psoriasis: an update on topical and systemic therapies. Aust Prescr. 2025 Jun;48(3):87-92. doi: 10.18773/austprescr.2025.026.
• Background Schafer PH, Truzzi F, Parton A, Wu L, Kosek J, Zhang LH, Horan G, Saltari A, Quadri M, Lotti R, Marconi A, Pincelli C. Phosphodiesterase 4 in inflammatory diseases: Effects of apremilast in psoriatic blood and in dermal myofibroblasts through the PDE4/CD271 complex. Cell Signal. 2016 Jul;28(7):753-63. doi: 10.1016/j.cellsig.2016.01.007. Epub 2016 Jan 22.
• Background Ponikowska M, Vellone E, Czapla M, Uchmanowicz I. Challenges Psoriasis and Its Impact on Quality of Life: Challenges in Treatment and Management. Psoriasis (Auckl). 2025 May 1;15:175-183. doi: 10.2147/PTT.S519420. eCollection 2025.
• Background Parisi R, Iskandar IYK, Kontopantelis E, Augustin M, Griffiths CEM, Ashcroft DM; Global Psoriasis Atlas. National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study. BMJ. 2020 May 28;369:m1590. doi: 10.1136/bmj.m1590.

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