Topical Methotrexate Microemulsion in the Treatment of Plaque Psoriasis

NCT04971239 | Unknown Phase 4

• 1 other identifier: MTXPSORIASIS
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

• Psoriasis is a chronic relapsing dermatological disease which often necessitates a long-term therapy and occurs in a significant percent of the population . It affects the skin and sometimes the nails and joints of patients .
• Psoriatic patients are frequently categorized into two groups: mild or moderate to severe psoriasis, depending on the clinical severity of the lesions, the percentage of affected body surface area, and patient quality of life .
• Topical drug therapy is the cornerstone in the treatment of mild to moderate psoriasis. It offers a direct targeting of affected skin by avoiding systemic adverse events .
• Several topical therapies are available for the treatment of psoriasis such as topical steroid , topical vitamin D3 analogues (calcipotriol),tar, anthraline, topical tacrolimus (a non-steroidal calcineurin inhibitor) and tazarotene (a third-generation retinoid) . However, they do not provide an adequate response owing to the inadequate percutaneous absorption and poor patient compliance caused by greasiness and stickiness of some formulations, and some patients even remain untreated .
• So that, patient satisfaction with available topical treatments remains modest .

Conditions

Psoriasis; Methotrexate

Keywords

psoriasis

Outcome Measures

Primary Outcomes (1)

• percentage of clinically improved patients using psoriasis severity index

  clinical assessment using psoriasis severity index

  three months

Study Arms (3)

topical methotrexate microemulsion

ACTIVE COMPARATOR

Group(A): topical methotrexate micro emulsion formulation, each patient will be instructed to apply a very thin film of 0.5 ml of it over the three psoriatic plaques three times weekly .

Drug: topical methotrexate micoemulsion

combination of topical methotrexate microemulsion and excimer light

EXPERIMENTAL

Group(B) : excimer laser will be done twice weekly on a different psoriatic plaques in combination with topical methotrexate micro emulsion for a total treatment course of 12 weeks.

Drug: topical methotrexate micoemulsion; Device: Excimer light

combination of topical methotrexate microemulsion and narrow band-ultraviolet B

EXPERIMENTAL

Group(C) : Narrow band ultraviolet B will be done twice weekly on a different psoriatic plaques in combination with topical methotrexate micro emulsion for a total treatment course of 12 weeks

Drug: topical methotrexate micoemulsion; Device: Narrow band ultraviolet B

Interventions

topical methotrexate micoemulsion DRUG

The selected microemulsion composition consists of 40% Jojoba oil, 45% Tween-80 and Span-85 at a ratio of 3:1 as surfactant and co surfactant, respectively and 15% water. The chosen concentration was based on preliminary studies conducted which delineated that these ratios provided the best skin deposition based on factorial skin modelling.The prepared microemulsions contains 0.1% methotrexate

Also known as: Methotrexate nano-emulsion

combination of topical methotrexate microemulsion and excimer light; combination of topical methotrexate microemulsion and narrow band-ultraviolet B; topical methotrexate microemulsion

Excimer light DEVICE

the excimer laser will be done twice weekly for a total treatment course of 12 weeks.

combination of topical methotrexate microemulsion and excimer light

Narrow band ultraviolet B DEVICE

the Narrow band ultraviolet B will be done twice weekly for a total treatment course of 12 weeks.

Also known as: NB-UVB

combination of topical methotrexate microemulsion and narrow band-ultraviolet B

Eligibility Criteria

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

You may qualify if:

• Thirty patients with mild psoriasis will be recruited from the Dermatology Outpatient Clinic, Assiut University Hospital.
• The diagnosis will be based upon the clinical characteristics of plaque psoriasis.
• Patients will be included after they have stopped any systemic therapy for at least 8 weeks and topical therapy for at least 2 weeks.

You may not qualify if:

• Patients having cardiovascular, renal or liver diseases.
• Patients with photosensitive or psychological disorders or immunodeficient patients.
• Pregnant or lactating woman

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• Goff KL, Karimkhani C, Boyers LN, Weinstock MA, Lott JP, Hay RJ, Coffeng LE, Norton SA, Naldi L, Dunnick C, Armstrong AW, Dellavalle RP. The global burden of psoriatic skin disease. Br J Dermatol. 2015 Jun;172(6):1665-1668. doi: 10.1111/bjd.13715. Epub 2015 May 6. No abstract available.

  PMID: 25645671 RESULT

• Mrowietz U, Kragballe K, Reich K, Spuls P, Griffiths CE, Nast A, Franke J, Antoniou C, Arenberger P, Balieva F, Bylaite M, Correia O, Dauden E, Gisondi P, Iversen L, Kemeny L, Lahfa M, Nijsten T, Rantanen T, Reich A, Rosenbach T, Segaert S, Smith C, Talme T, Volc-Platzer B, Yawalkar N. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan;303(1):1-10. doi: 10.1007/s00403-010-1080-1. Epub 2010 Sep 21.

  PMID: 20857129 RESULT

• Wollina U, Tirant M, Vojvodic A, Lotti T. Treatment of Psoriasis: Novel Approaches to Topical Delivery. Open Access Maced J Med Sci. 2019 Aug 30;7(18):3018-3025. doi: 10.3889/oamjms.2019.414. eCollection 2019 Sep 30.

  PMID: 31850114 RESULT

• Abdelgawad R, Nasr M, Moftah NH, Hamza MY. Phospholipid membrane tubulation using ceramide doping "Cerosomes": Characterization and clinical application in psoriasis treatment. Eur J Pharm Sci. 2017 Apr 1;101:258-268. doi: 10.1016/j.ejps.2017.02.030. Epub 2017 Feb 21.

  PMID: 28232140 RESULT

• Florek AG, Wang CJ, Armstrong AW. Treatment preferences and treatment satisfaction among psoriasis patients: a systematic review. Arch Dermatol Res. 2018 May;310(4):271-319. doi: 10.1007/s00403-018-1808-x. Epub 2018 Feb 13.

  PMID: 29442137 RESULT

• Carretero G, Puig L, Dehesa L, Carrascosa JM, Ribera M, Sanchez-Regana M, Dauden E, Vidal D, Alsina M, Munoz-Santos C, Lopez-Estebaranz JL, Notario J, Ferrandiz C, Vanaclocha F, Garcia-Bustinduy M, Taberner R, Belinchon I, Sanchez-Carazo J, Moreno JC; Grupo de Psoriasis de la AEDV. [Guidelines on the use of methotrexate in psoriasis]. Actas Dermosifiliogr. 2010 Sep;101(7):600-13. Spanish.

  PMID: 20858386 RESULT

• Ramez SA, Soliman MM, Fadel M, Nour El-Deen F, Nasr M, Youness ER, Aboel-Fadl DM. Novel methotrexate soft nanocarrier/fractional erbium YAG laser combination for clinical treatment of plaque psoriasis. Artif Cells Nanomed Biotechnol. 2018;46(sup1):996-1002. doi: 10.1080/21691401.2018.1440236. Epub 2018 Feb 15.

  PMID: 29448838 RESULT

• Ali MF, Salah M, Rafea M, Saleh N. Liposomal methotrexate hydrogel for treatment of localized psoriasis: preparation, characterization and laser targeting. Med Sci Monit. 2008 Dec;14(12):PI66-74.

  PMID: 19043379 RESULT

• Wong TW, Zhao YL, Sen A, Hui SW. Pilot study of topical delivery of methotrexate by electroporation. Br J Dermatol. 2005 Mar;152(3):524-30. doi: 10.1111/j.1365-2133.2005.06455.x.

  PMID: 15787822 RESULT

• Nasr M, Abdel-Hamid S, Moftah NH, Fadel M, Alyoussef AA. Jojoba Oil Soft Colloidal Nanocarrier of a Synthetic Retinoid: Preparation, Characterization and Clinical Efficacy in Psoriatic Patients. Curr Drug Deliv. 2017;14(3):426-432. doi: 10.2174/1567201813666160513132321.

  PMID: 27174314 RESULT

• Gianfaldoni S, Gianfaldoni R, Wollina U, Lotti J, Tchernev G, Lotti T. An Overview on Radiotherapy: From Its History to Its Current Applications in Dermatology. Open Access Maced J Med Sci. 2017 Jul 18;5(4):521-525. doi: 10.3889/oamjms.2017.122. eCollection 2017 Jul 25.

  PMID: 28785349 RESULT

• Mehraban S, Feily A. 308nm excimer laser in dermatology. J Lasers Med Sci. 2014 Winter;5(1):8-12.

  PMID: 25606333 RESULT

• Langley RG, Ellis CN. Evaluating psoriasis with Psoriasis Area and Severity Index, Psoriasis Global Assessment, and Lattice System Physician's Global Assessment. J Am Acad Dermatol. 2004 Oct;51(4):563-9. doi: 10.1016/j.jaad.2004.04.012.

  PMID: 15389191 RESULT

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dalia A Ahmed, professor

CONTACT

+201005677229; daliaattallah@yahoo.com

Rofaida R Shehata, Lecturer

CONTACT

+201006897580; Rofaida.refaat@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ayat Mahmoud Abdel Salam

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 21, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share