Evaluation of Topical Apremilast Nanoparticles in the Treatment of Plaque Psoriasis: Clinical, Histopathological and Immunohistochemical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 36
- Primary Endpoint
- Change in Psoriasis thickness,erythema, and scaling (TES score) from baseline to Week 12
Study Overview
Brief 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.
Detailed Description
Psoriasis is a chronic immune-mediated inflammatory skin condition with a strong genetic predisposition and an autoimmune pathogenic characteristic . Its worldwide prevalence is up to 2% but this varies between different geographic regions . In Egypt, the prevalence of psoriasis ranges between 0.19% and 3% .
Individuals with psoriasis frequently endure marked psychological distress. This includes social embarrassment, reduced self esteem, anxiety, depression, and an increased tendency toward suicidal ideation and behavior .
Psoriasis Skin lesions are usually symmetrical, sharply demarcated, with red or pink raised plaques, and covered with silvery scales. These plaques reflect key pathological processes, including inflammation, keratinocyte hyperproliferation, and angiogenesis .
Cellular responses to environmental stimuli and intracellular signaling in various cell types-including myeloid, lymphoid, and other inflammatory cells-are mediated by intracellular "second messengers," particularly cyclic adenosine monophosphate (cAMP) .
Phosphodiesterase4 (PDE4) is one of the major cAMP-selective PDEs expressed in epithelial cells . It is also present in several mesenchymal cell types, including dermal keratinocytes, smooth muscle cells, vascular endothelial cells, and chondrocytes, By decreasing intracellular cAMP, PDE4 promotes production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. Conversely, inhibition of PDE4 increases the intracellular concentration of cAMP and selectively blocks pro-inflammatory cytokines, such as TNF-α, IFN-γ, and IL-2 production from peripheral blood monocytes and T cells.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: ≥18 years.
- •Pattern: Patients with chronic plaque psoriasis not exceeding 10% of the body surface area.
Exclusion Criteria
- •History of phototherapy or systemic treatment in the previous 12 weeks, topical psoriasis treatment within the last 4 weeks.
- •Renal, hepatic disease, cardiovascular, Immunosuppressive therapy, endocrine and blood disease or mental illness.
- •Pregnancy, breast-feeding or women planning to become pregnant within 3 months.
- •Psoriasis exceeding 10% of body surface area or other severe types of psoriasis requiring systemic treatment.
Arms & Interventions
Topical Apremilast Nanoformula
Participants will receive topical apremilast nanoformula 0.3% applied twice daily for 12 weeks.
Intervention: Apremilast Nanoformula 0.3٪ (Drug)
Topical betamethasone valerate
Participants will receive topical betamethasone valerate 0.1% cream applied twice daily for 12 weeks.
Intervention: betamethasone valerate 0.1% cream (Drug)
Combination therapy
Participants will receive combined topical apremilast nanoformula 0.3% and topical betamethasone valerate 0.1% cream applied for 12 weeks.
Intervention: Apremilast Nanoformula 0.3٪ (Drug)
Combination therapy
Participants will receive combined topical apremilast nanoformula 0.3% and topical betamethasone valerate 0.1% cream applied for 12 weeks.
Intervention: betamethasone valerate 0.1% cream (Drug)
Outcomes
Primary Outcomes
Change in Psoriasis thickness,erythema, and scaling (TES score) from baseline to Week 12
Time Frame: Baseline to week 12 and two months after to detect recurrence .
To evaluate the efficacy and safety of topical apremilast nanoemulsion 0.3٪ for treatment of localized plaque psoriasis as a monotherapy versus topical betamethasone valerate 0.1٪ cream alone and its combination with a topical betamethasone valerate 0.1٪ cream
Secondary Outcomes
- Change in dermoscopic features of psoriatic plaques from baseline to Week 12(Baseline to week 12)
- Change in histopathological features of psoriatic plaques from baseline to Week 12(Baseline to week 12)
- Change in immunohistochemical expression of PDE4( B/C/D) from baseline to Week 12(Baseline to week 12)
Investigators
Aliaa Effat Saied Sayed
Assistant lecturer
Assiut University