Topical Methotrexate Microemulsion in the Treatment of Plaque Psoriasis

July 12, 2021 updated by: Ayat Mahmoud Abdelsalam, Assiut University

The Efficacy and Safety of Topical Methotrexate Microemulsion in Combination With Excimer Light and Narrow Band-ultraviolet B in the Treatment of Plaque Psoriasis

  • 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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  • Methotrexate was US Food and Drug Administration approved for the treatment of psoriasis, and is currently recommended for practically all forms of moderate or severe psoriasis, including psoriatic arthritis .
  • Methotrexate competitively inhibits dihydrofolate reductase enzyme which converts dihydrofolate to tetrahydrofolate (fully reduced folic acid); the latter being a necessary cofactor in the synthesis of DNA . Because systemic Methotrexate is associated with several adverse effects, topical Methotrexate has become a more-interesting alternative .
  • However, the topical action of Methotrexate is challenging, since it suffers limited percutaneous diffusivity owing to its aqueous solubility, its ionization at physiological pH, and unfavorable lipid/water coefficient .
  • A remedy to this problem might be the utilization of a suitable customized nano-based delivery system for enhancing the topical percutaneous penetration of MTX for treatment of psoriasis .
  • Micro emulsions are among the most promising nanocarriers, being composed of aqueous and oily phases in addition to surfactants and cosurfactants . Only one study used micro emulsion as a topical nanocarrier for MTX, and jojoba oil will be selected as the oily phase of the micro emulsion since it exhibits moisturizing and anti-inflammatory effects which are beneficial in psoriasis treatment .
  • The physical therapies used for the treatment of psoriasis include PUVA, broad band ultraviolet ray, Narrowband ultraviolet B and monochromatic excimer laser and light.
  • Narrowband ultraviolet B (307-311 nm) showed efficacy in the treatment of psoriasis. This therapeutic approach considers that psoriasis patients undergoing phototherapy usually receive high cumulative doses of radiation during their lives, thus leading to secondary cutaneous disorders, like photoaging, telangiectasias, excessive tanning .
  • On the contrary, The monochromatic excimer light device delivers ultraviolet B wavelength at 308 nm only to the lesional skin, could lower all these collateral effects dramatically and decreasing the total dose of radiation. Moreover, the treatment may be tailored to each affected area with different doses of ultraviolet makes monochromatic excimer laser and light mostly appreciated to a large part of patients, thus increasing treatment compliance, which is particularly useful when we have to deal with long-lasting therapeutic protocols.
  • Finally, the possibility to focus the radiations on skin lesions is believed to reduces the risks of acute and chronic side effects in the uninvolved safe skin
  • Several studies showed its effectiveness in the treatment of psoriasis as a monotherapy or in combination with several topical therapies such as flumetasone, dithranol, calcipotriol , but no study investigate its efficacy in combination with topical methotrexate yet.
  • In recent years, the new biological therapies (monoclonal antibodies, receptor fusion proteins and similar) have been developed to manage psoriasis in its inner mechanisms of immune regulation. However, the legal (i.e. FDA and EMA-approved use of biologics in psoriasis) and scientific limitations (i.e. guidelines) for the use of biologics, together with the major possible medical involvements connected to this category of therapeutic agents and their expensive cost, make of them a treatment dedicated to a few well-chosen patients .

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: topical methotrexate microemulsion
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
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
Other Names:
  • Methotrexate nano-emulsion
Experimental: combination of topical methotrexate microemulsion and excimer light
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
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
Other Names:
  • Methotrexate nano-emulsion
Device: Excimer light
the excimer laser will be done twice weekly for a total treatment course of 12 weeks.
Experimental: combination of topical methotrexate microemulsion and narrow band-ultraviolet B
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
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
Other Names:
  • Methotrexate nano-emulsion
Device: Narrow band ultraviolet B
the Narrow band ultraviolet B will be done twice weekly for a total treatment course of 12 weeks.
Other Names:
  • NB-UVB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of clinically improved patients using psoriasis severity index
Time Frame: three months
clinical assessment using psoriasis severity index
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTXPSORIASIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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