Topical 1% Methotrexate Gel Versus Clobetasol Propionate in Patients With Psoriasis

August 14, 2024 updated by: John Benjamin B. Gochoco, Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium

A Pilot Study of Topical 1% Methotrexate Gel Versus Clobetasol Propionate in Patients With Mild-moderate Plaque-type Psoriasis

A pilot study on the formulation of topical methotrexate was conducted. Patients after baseline evaluation were randomly placed into either topical 1% methotrexate gel or clobetasol propionate 0.05% ointment which was applied for 6 weeks. PASI score was assessed at two-week intervals for a total of eight weeks. Blood chemistry parameters, whole abdomen ultrasound, and adverse drug reactions while on treatment and after eight weeks were monitored as secondary outcome measures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a pilot study done for a year at the dermatologic clinic of a tertiary hospital. The study was approved by the Institutional Review Board and followed the declaration of Helsinki Principles for patient rights.

Patients clinically diagnosed with psoriasis were chosen for the study. Inclusion criteria for the participants include the following: patients with stable mild-moderate plaque psoriasis, regardless of chronicity of the disease, involving less than 30% of the body surface area (BSA) with a negative pregnancy test for female participants of reproductive age. On the other hand, the exclusion criteria for the participants include the following: patients with psoriatic lesions on the face and/or scalp, administration of topical, systemic, or intralesional therapy or UV radiation therapy for at least 2 weeks before the study. Patients with deranged laboratory results at the baseline of the study, minors or lactating mothers, and patients planning a pregnancy with their spouses/partners in the next three months.

The gathered patients with psoriasis were randomly and equally divided, by a tossed coin, into two groups according to the type of treatment the participant received. Group I was treated with the MTX 1% gel while the other group was treated with clobetasol propionate 0.05% ointment. The sampling method used was complete enumeration sampling was used for patients with psoriasis from 2022 to 2023. Should the number of willing participants for the study exceed the determined sample size, only the first patients to satisfy the inclusion criteria were included in the study. The study blinded the participants, the investigators, and the statistician when it came to the treatment involved until the trial was finished.

After the patient agreed to the set guidelines of the study, photographs of the lesions, PASI score, and laboratory parameters including blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and whole abdomen ultrasound were taken at baseline of the study. These laboratories were once again done on week 6 at the end of the application of the assigned topical. The participants were asked to return for follow-up after two weeks of wash-out period, week 8, to see if there was sustained remission defined as no new psoriatic lesion after two weeks of discontinuation of the assigned topical medication. The procedure for this study is detailed in Figure 1.

The withdrawal criteria for the participants in the study were as follows: experienced exacerbation defined as a 125% increase of PASI from the baseline, failure to apply the medication for two consecutive days, failure to appear in one of the follow-up consultations which was done every two weeks. Appearance of adverse drug reactions such as, but not limited to: new lesions, increase in erythema, scaling, or thickening of previous lesions, and intractable pruritus. If any of the abovementioned criteria were present, the participant was asked to discontinue the use of the trial medication and was given the standard treatment therapy (topical corticosteroid) instead.

The intervention used in the study comprised of identical blue-green containers filled with either MTX 1% gel or clobetasol propionate 0.05% ointment and were given to the study participants. They were instructed to apply only to the psoriatic lesion. Participants were educated to recognize common side effects such as stings of dermatitis, irritation, and burning. Each Participant was instructed to apply the given topical formula twice daily for six weeks. No occlusion dressings were used. Avoidance to prolonged sunlight exposure as well as the use of other emollients were advised.

Primary endpoints is the BSA involved in the psoriasis lesions and PASI score. Secondary endpoints include the result of the laboratory parameters of the patient after week six and determination of noted adverse drug reactions on both treatment arms.

The PASI scores of the participants were assessed with an independent sample t-test for comparison between variables.7 Data were analyzed on Statistical Package for Social Science (SPSS) version 11. A p-value of less than 0.05 was considered as significant.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Early Phase 1

Contacts and Locations

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

Study Locations

  • Philippines
    • Metro Manila
      • Caloocan, Metro Manila, Philippines, 1427
        • Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients with stable mild-moderate plaque psoriasis, regardless of chronicity of the disease,
  • involving less than 30% of the body surface area (BSA)
  • negative pregnancy test for female participants of reproductive age

Exclusion Criteria:

  • patients with psoriatic lesions on the face and/or scalp,
  • administration of topical, systemic, or intralesional therapy or UV radiation therapy for at least 2 weeks before the study.
  • Patients with deranged laboratory results at the baseline of the study, minors or lactating mothers
  • patients planning a pregnancy with their spouses/partners in the next three months.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: topical 1% methotrexate gel
topical 1% methotrexate gel 2x a day for 6 weeks
Drug: topical 1% methotrexate gel
topical 1% methotrexate gel
Other Names:
  • clobetasol propionate 0.05% ointment
Active Comparator: clobetasol propionate 0.05% ointment
clobetasol propionate 0.05% ointment 2x a day for 6 weeks
Drug: clobetasol propionate 0.05% ointment
clobetasol propionate 0.05% ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Psoriasis Area and Severity Index (PASI) score computed
Time Frame: 8 weeks
Psoriasis Area and Severity Index scores range from 0 to 72. In general, the higher the PASI score, the more severe is the disease
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in baseline laboratory results
Time Frame: 8 weeks
blood urea nitrogen (BUN)
8 weeks
Change in baseline laboratory results
Time Frame: 8 weeks
creatinine
8 weeks
Change in baseline laboratory results
Time Frame: 8 weeks
alanine aminotransferase (ALT)
8 weeks
Change in baseline laboratory results
Time Frame: 8 weeks
aspartate aminotransferase (AST)
8 weeks
Change in baseline laboratory results
Time Frame: 8 weeks
whole abdomen ultrasound
8 weeks

Collaborators and Investigators

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

Sponsor

Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium

Investigators

  • Principal Investigator: John Benjamin B Gochoco, MD, Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium

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 (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JNRodriguezMHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The whole study will be available

IPD Sharing Time Frame

1 year

IPD Sharing Access Criteria

Access to all

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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