Evaluation the Topical Apremilast Nanoformulation in Treatment of Localized Plaque Psoriasis

Sponsor
Assiut University
Study ID
NCT07366268
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apremilast Nanoformula 0.3٪ — DRUG
    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 — DRUG
    • 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

Study Details

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.

Key Dates

First listed
Jan 26, 2026
Start date
May 31, 2026
Status verified
Jan 2026
Primary completion
May 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Topical Apremilast Nanoformula
    Participants will receive topical apremilast nanoformula 0.3% applied twice daily for 12 weeks.
  • Active Comparator: Topical betamethasone valerate
    Participants will receive topical betamethasone valerate 0.1% cream applied twice daily for 12 weeks.
  • Experimental: Combination therapy
    Participants will receive combined topical apremilast nanoformula 0.3% and topical betamethasone valerate 0.1% cream applied for 12 weeks.

Primary Outcome Measure

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 . ]

Central Contacts

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