PsoriasisNCT07366268
Evaluation the Topical Apremilast Nanoformulation in Treatment of Localized Plaque Psoriasis
A study testing Apremilast Nanoformula 0.3٪ and betamethasone valerate 0.1% cream in people with Psoriasis, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Apremilast Nanoformula 0.3٪ and betamethasone valerate 0.1% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years.
- Pattern: Patients with chronic plaque psoriasis not exceeding 10% of the body surface area.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Topical Apremilast Nanoparticles in the Treatment of Plaque Psoriasis: Clinical, Histopathological and Immunohistochemical Study
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.
Read the 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.
PDE4 has four subtypes (A, B, C and D). These subtypes are encoded on separate genes. Expression of the PDE4A subtype increased in nearly all cell types of the skin of psoriasis patients. PDE4B is present in vessels and in immune cells, whereas PDE4D is expressed in fibroblasts and endothelial cells .
Management of mild to moderate psoriasis usually begins with topical therapies, including emollients, topical corticosteroids, calcipotriol, tar preparations, and dithranol. There is little evidence to guide the selection of topical treatments, so it can be based on patient and prescriber preference .
Topical glucocorticoids are the first-line therapy in mild to moderate psoriasis and areas where other topical treatments may cause irritation, such as joints or genitals . Corticosteroids bind to intracellular corticosteroid receptor and regulate gene transcription of numerous genes, particularly those that code for pro-inflammatory cytokines. They act as vasoconstrictive, antiproliferative, anti-inflammatory and immunosuppressive.
However, long-term application of topical corticosteroids may cause skin atrophy, striae, telangiectasia, adrenal suppression and hypopigmentation. Additionally, abrupt discontinuation can precipitate early disease relapse or rebound flares.
Apremilast is classified as a small-molecule phosphodiesterase4 (PDE4) inhibitor , It inhibits PDE4 isoforms from all four sub-families (A,B,C,D) Apremilast acts by hindering the conversion of cyclic adenosine monophosphate (cAMP) to AMP . further causing an intracellular accumulation of cyclic adenosine monophosphate (cAMP) causing a reduction in the production of inflammatory mediators such as CX-CL9, CX-CL10, IFN-γ, TNF-α, IL-2, IL-8, IL-12, and IL-23, thereby attenuating the inflammatory cascade .
Its oral form is FDA approved for plaque psoriasis in adult patients eligible for systemic therapy or phototherapy, as well as for adults with moderately to severely active psoriatic arthritis. . It is recommended that apremilast be titrated to the recommended dose of 30 mg twice daily, to be taken orally starting on day 6 .
The results of long-term, placebo-controlled study (ESTEEM 2) established the efficacy of oral apremilast in patients with plaque psoriasis, and are consistent with those reported in ESTEEM 1.The primary end point in this study was met, with a significantly greater proportion of patients treated with apremilast achieving a PASI 75 response at week 16 vs. placebo. Across different phases of study, PASI 75 responses at week 16 have ranged from 29% to 41%.
Apremilast is low soluble and low permeable classifying the drug as biopharmaceutical classification system (BCS) class 4 molecule with a poor solubility of 10-14 μg/mL. The oral medication of apremilast has systemic side effects such as diarrhea, nausea, vomiting, weight loss, and depression in some cases .
These limitations highlight the need for alternative routes of administration that enhance drug delivery to affected skin while minimizing systemic exposure. Topical delivery of apremilast represents a promising strategy to achieve localized therapeutic effects with fewer systemic side effects and improve patient outcomes .
Nevertheless, poor solubility and limited skin penetration restrict the effectiveness of topical apremilast, particularly in psoriatic skin, which is thickened and inflamed . Hence, the incorporation into nanotechnology-based drug delivery systems could be used as a strategy to improve its solubility and permeability in order to improve dermal bioavailability and consequently to achieve local anti-inflammatory efficacy .
Several ex vivo studies have demonstrated that apremilast loaded nanoparticles significantly increase skin retention compared with conventional gel formulations, resulting in improved therapeutic outcomes. Cytotoxicity and skin irritation studies further indicate that nano formulations are safe and well tolerated .
- Conditions
- Psoriasis
- Being tested
- Apremilast Nanoformula 0.3٪, betamethasone valerate 0.1% cream
- Keywords
- Psoriasis, Apremilast, Nanotechnology, Topical
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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% creamDrug
- 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 group | Role | What they receive |
|---|---|---|
| Topical Apremilast Nanoformula | Experimental | Participants will receive topical apremilast nanoformula 0.3% applied twice daily for 12 weeks. Receives: 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. Receives: 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. Receives: Drug: Apremilast Nanoformula 0.3٪; Drug: betamethasone valerate 0.1% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline to week 12
Change in histopathological features of psoriatic plaques from baseline to Week 12
Measured: Baseline to week 12
Change in immunohistochemical expression of PDE4( B/C/D) from baseline to Week 12
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each Participant will receive the different treatment included within the study( intrapatient study)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Effat Saied Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366268
- Sponsor's protocol ID
- Nano Apremilast in psoriasis
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23437104Nestor 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.
PubMed 32129962Louden 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.
PubMed 15530297Parmar 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.
PubMed 32588281Rapalli 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.
PubMed 37018989Sarango-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.
PubMed 33371334Papp 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.
PubMed 22748702Papp 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.
PubMed 26089047Paul 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.
PubMed 26357944Schafer 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.
PubMed 24882690Ahmed 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.
PubMed 37822388Chan JJ. Psoriasis: an update on topical and systemic therapies. Aust Prescr. 2025 Jun;48(3):87-92. doi: 10.18773/austprescr.2025.026.
PubMed 40568686Schafer 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.
PubMed 26806620Ponikowska 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.
PubMed 40330837Parisi 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.
PubMed 32467098
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical Apremilast Nanoparticles in the Treatment of Plaque Psoriasis: Clinical, Histopathological and Immunohistochemical Study
- ClinicalTrials.gov ID
- NCT07366268
- Acronym / sponsor ID
- Nano Apremilast in psoriasis
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Apremilast, Nanotechnology, Topical
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
PDE4 has four subtypes (A, B, C and D). These subtypes are encoded on separate genes. Expression of the PDE4A subtype increased in nearly all cell types of the skin of psoriasis patients. PDE4B is present in vessels and in immune cells, whereas PDE4D is expressed in fibroblasts and endothelial cells .
Management of mild to moderate psoriasis usually begins with topical therapies, including emollients, topical corticosteroids, calcipotriol, tar preparations, and dithranol. There is little evidence to guide the selection of topical treatments, so it can be based on patient and prescriber preference .
Topical glucocorticoids are the first-line therapy in mild to moderate psoriasis and areas where other topical treatments may cause irritation, such as joints or genitals . Corticosteroids bind to intracellular corticosteroid receptor and regulate gene transcription of numerous genes, particularly those that code for pro-inflammatory cytokines. They act as vasoconstrictive, antiproliferative, anti-inflammatory and immunosuppressive.
However, long-term application of topical corticosteroids may cause skin atrophy, striae, telangiectasia, adrenal suppression and hypopigmentation. Additionally, abrupt discontinuation can precipitate early disease relapse or rebound flares.
Apremilast is classified as a small-molecule phosphodiesterase4 (PDE4) inhibitor , It inhibits PDE4 isoforms from all four sub-families (A,B,C,D) Apremilast acts by hindering the conversion of cyclic adenosine monophosphate (cAMP) to AMP . further causing an intracellular accumulation of cyclic adenosine monophosphate (cAMP) causing a reduction in the production of inflammatory mediators such as CX-CL9, CX-CL10, IFN-γ, TNF-α, IL-2, IL-8, IL-12, and IL-23, thereby attenuating the inflammatory cascade .
Its oral form is FDA approved for plaque psoriasis in adult patients eligible for systemic therapy or phototherapy, as well as for adults with moderately to severely active psoriatic arthritis. . It is recommended that apremilast be titrated to the recommended dose of 30 mg twice daily, to be taken orally starting on day 6 .
The results of long-term, placebo-controlled study (ESTEEM 2) established the efficacy of oral apremilast in patients with plaque psoriasis, and are consistent with those reported in ESTEEM 1.The primary end point in this study was met, with a significantly greater proportion of patients treated with apremilast achieving a PASI 75 response at week 16 vs. placebo. Across different phases of study, PASI 75 responses at week 16 have ranged from 29% to 41%.
Apremilast is low soluble and low permeable classifying the drug as biopharmaceutical classification system (BCS) class 4 molecule with a poor solubility of 10-14 μg/mL. The oral medication of apremilast has systemic side effects such as diarrhea, nausea, vomiting, weight loss, and depression in some cases .
These limitations highlight the need for alternative routes of administration that enhance drug delivery to affected skin while minimizing systemic exposure. Topical delivery of apremilast represents a promising strategy to achieve localized therapeutic effects with fewer systemic side effects and improve patient outcomes .
Nevertheless, poor solubility and limited skin penetration restrict the effectiveness of topical apremilast, particularly in psoriatic skin, which is thickened and inflamed . Hence, the incorporation into nanotechnology-based drug delivery systems could be used as a strategy to improve its solubility and permeability in order to improve dermal bioavailability and consequently to achieve local anti-inflammatory efficacy .
Several ex vivo studies have demonstrated that apremilast loaded nanoparticles significantly increase skin retention compared with conventional gel formulations, resulting in improved therapeutic outcomes. Cytotoxicity and skin irritation studies further indicate that nano formulations are safe and well tolerated .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Each Participant will receive the different treatment included within the study( intrapatient study)
| Arm | Type | Receives |
|---|---|---|
| Topical Apremilast Nanoformula | Experimental | Drug: Apremilast Nanoformula 0.3٪Participants will receive topical apremilast nanoformula 0.3% applied twice daily for 12 weeks. |
| Topical betamethasone valerate | Active comparator | Drug: betamethasone valerate 0.1% creamParticipants will receive topical betamethasone valerate 0.1% cream applied twice daily for 12 weeks. |
| Combination therapy | Experimental | Drug: Apremilast Nanoformula 0.3٪, Drug: betamethasone valerate 0.1% creamParticipants will receive combined topical apremilast nanoformula 0.3% and topical betamethasone valerate 0.1% cream applied for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: ≥18 years.
- Pattern: Patients with chronic plaque psoriasis not exceeding 10% of the body surface area.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Combination therapy, Topical Apremilast Nanoformula |
| 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 | Drug | Combination therapy, Topical betamethasone valerate |
Primary outcome
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
3 secondary outcomes
Change in dermoscopic features of psoriatic plaques from baseline to Week 12
Time frame: Baseline to week 12
Change in histopathological features of psoriatic plaques from baseline to Week 12
Time frame: Baseline to week 12
Change in immunohistochemical expression of PDE4( B/C/D) from baseline to Week 12
Time frame: Baseline to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 23437104Delestras 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: PubMed 32129962Nestor 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: PubMed 15530297Louden 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: PubMed 32588281Parmar 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: PubMed 37018989Rapalli 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: PubMed 33371334Sarango-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: PubMed 22748702Papp 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: PubMed 26089047Papp 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: PubMed 26357944Paul 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: PubMed 24882690Schafer 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: PubMed 37822388Ahmed 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: PubMed 40568686Chan JJ. Psoriasis: an update on topical and systemic therapies. Aust Prescr. 2025 Jun;48(3):87-92. doi: 10.18773/austprescr.2025.026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Apremilast Nanoformula 0.3٪ and betamethasone valerate 0.1% cream in people with Psoriasis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heba Hassan Hassan, Dr (01002866919, hebahasan16888@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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 .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07366268, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.