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Evaluation the Topical Apremilast Nanoformulation in Treatment of Localized Plaque Psoriasis
Sponsor: Assiut University
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.
Official title: Evaluation of Topical Apremilast Nanoparticles in the Treatment of Plaque Psoriasis: Clinical, Histopathological and Immunohistochemical Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-05
Completion Date
2028-03
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
Apremilast Nanoformula 0.3٪
the nano based formula of apremilast will be prepared from its raw powder at Assuit international center of nanomedicine, Alrajhy Liver hospital, Assuit university. Nanoparticles loaded-apremilast 0.3% will be filled into sealed containers labeled as (number 1) and provided to patients and they will be instructed to apply thin a film twice daily for 12 weeks
betamethasone valerate 0.1% cream
• Betamethsone valerate cream 0.1%: The commercially available betamethasone valerate cream will be re-packaged into identical, non-identifiable containers labeled (number 2 ) in order to ensure patient blinding and it will be applied twice daily for 12 weeks