Evaluation the Topical Apremilast Nanoformulation in Treatment of Localized Plaque Psoriasis

NCT07366268 | Not Yet Recruiting

• 1 other identifier: Nano Apremilast in psoriasis
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Keywords

Psoriasis; Apremilast; Nanotechnology; Topical

Outcome Measures

Primary Outcomes (1)

• Change in Psoriasis thickness,erythema, and scaling (TES score) from baseline to Week 12

  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

  Baseline to week 12 and two months after to detect recurrence .

Secondary Outcomes (3)

• 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

Study Arms (3)

Topical Apremilast Nanoformula

EXPERIMENTAL

Participants will receive topical apremilast nanoformula 0.3% applied twice daily for 12 weeks.

Drug: Apremilast Nanoformula 0.3٪

Topical betamethasone valerate

ACTIVE COMPARATOR

Participants will receive topical betamethasone valerate 0.1% cream applied twice daily for 12 weeks.

Drug: betamethasone valerate 0.1% cream

Combination therapy

EXPERIMENTAL

Participants will receive combined topical apremilast nanoformula 0.3% and topical betamethasone valerate 0.1% cream applied for 12 weeks.

Drug: Apremilast Nanoformula 0.3٪; Drug: betamethasone valerate 0.1% cream

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

Combination therapy; Topical Apremilast Nanoformula

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

Combination therapy; Topical betamethasone valerate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥18 years.
• Pattern: Patients with chronic plaque psoriasis not exceeding 10% of the body surface area.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (15)

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MeSH Terms

Conditions

Psoriasis

Interventions

Betamethasone Valerate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Heba Hassan Hassan, Dr

CONTACT

01002866919; hebahasan16888@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Each Participant will receive the different treatment included within the study( intrapatient study)

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: January 26, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-01