Clinical trial NCT06555497: Topical 1% Methotrexate Gel Versus Clobetasol Propionate in Patients With Psoriasis
Official title: A Pilot Study of Topical 1% Methotrexate Gel Versus Clobetasol Propionate in Patients With Mild-moderate Plaque-type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pilot Study
Psoriasis
Keywords: topical methotrexate gel
Clobetasol
Lead sponsor: Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Psoriasis Area and Severity Index (PASI) score computed
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in baseline laboratory results
timeFrame: 8 weeks
measure: Change in baseline laboratory results
timeFrame: 8 weeks
measure: Change in baseline laboratory results
timeFrame: 8 weeks
measure: Change in baseline laboratory results
timeFrame: 8 weeks
measure: Change in baseline laboratory results
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Caloocan
country: Philippines
facility: Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium
state: Metro Manila
Study officials:
affiliation: Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium
name: John Benjamin B Gochoco, MD
role: PRINCIPAL_INVESTIGATOR
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