NCT06555497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

August 7, 2024

Last Update Submit

August 14, 2024

Conditions

Pilot StudyPsoriasis

Keywords

topical methotrexate gelClobetasol

Outcome Measures

Primary Outcomes (1)

  • Change in Psoriasis Area and Severity Index (PASI) score computed

    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 Outcomes (5)

  • Change in baseline laboratory results

    8 weeks

  • Change in baseline laboratory results

    8 weeks

  • Change in baseline laboratory results

    8 weeks

  • Change in baseline laboratory results

    8 weeks

  • Change in baseline laboratory results

    8 weeks

Study Arms (2)

topical 1% methotrexate gel

EXPERIMENTAL

topical 1% methotrexate gel 2x a day for 6 weeks

Drug: topical 1% methotrexate gel

clobetasol propionate 0.05% ointment

ACTIVE COMPARATOR

clobetasol propionate 0.05% ointment 2x a day for 6 weeks

Drug: clobetasol propionate 0.05% ointment

Interventions

topical 1% methotrexate gelDRUG

topical 1% methotrexate gel

Also known as: clobetasol propionate 0.05% ointment
topical 1% methotrexate gel
clobetasol propionate 0.05% ointmentDRUG

clobetasol propionate 0.05% ointment

clobetasol propionate 0.05% ointment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium

Caloocan, National Capital Region, 1427, Philippines

Location

Related Publications (9)

  • Kimwell MJM, de Guzman DC, Onda AJM, Dofitas BL, Frez MLF, Mendoza CG, Rivera FD 4th, Almirol BJQ, Malaluan MJQ, Guce K. Economic Evaluation of Selected Interleukin Inhibitors Versus Methotrexate for Moderate-to-Severe Plaque Psoriasis From the Philippine Payer Perspective. Value Health Reg Issues. 2023 Mar;34:100-107. doi: 10.1016/j.vhri.2022.12.001. Epub 2023 Jan 11.

    PMID: 36638606BACKGROUND

  • Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.

    PMID: 19641206BACKGROUND

  • Sarac G, Koca TT, Baglan T. A brief summary of clinical types of psoriasis. North Clin Istanb. 2016 Jun 14;3(1):79-82. doi: 10.14744/nci.2016.16023. eCollection 2016.

    PMID: 28058392BACKGROUND

  • Hsu S, Papp KA, Lebwohl MG, Bagel J, Blauvelt A, Duffin KC, Crowley J, Eichenfield LF, Feldman SR, Fiorentino DF, Gelfand JM, Gottlieb AB, Jacobsen C, Kalb RE, Kavanaugh A, Korman NJ, Krueger GG, Michelon MA, Morison W, Ritchlin CT, Stein Gold L, Stone SP, Strober BE, Van Voorhees AS, Weiss SC, Wanat K, Bebo BF Jr; National Psoriasis Foundation Medical Board. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. doi: 10.1001/archdermatol.2011.1410.

    PMID: 22250239BACKGROUND

  • Haider S, Wahid Z, Najam-Us-Saher, Riaz F. Efficacy of Methotrexate in patients with plaque type psoriasis. Pak J Med Sci. 2014 Sep;30(5):1050-3. doi: 10.12669/pjms.305.4451.

    PMID: 25225524BACKGROUND

  • Pinto MF, Moura CC, Nunes C, Segundo MA, Costa Lima SA, Reis S. A new topical formulation for psoriasis: development of methotrexate-loaded nanostructured lipid carriers. Int J Pharm. 2014 Dec 30;477(1-2):519-26. doi: 10.1016/j.ijpharm.2014.10.067. Epub 2014 Nov 1.

    PMID: 25445970BACKGROUND

  • Dawson, B., & Trapp, R. G. (2001). Basic et clinical biostatistics. Buch. Lange Med. Books/Mcgraw-Hill.

    BACKGROUND

  • Coondoo A, Phiske M, Verma S, Lahiri K. Side-effects of topical steroids: A long overdue revisit. Indian Dermatol Online J. 2014 Oct;5(4):416-25. doi: 10.4103/2229-5178.142483.

    PMID: 25396122BACKGROUND

  • Zhou Y, Yang L, Lyu Y, Wu D, Zhu Y, Li J, Jiang D, Xin X, Yin L. Topical Delivery of ROS-Responsive Methotrexate Prodrug Nanoassemblies by a Dissolvable Microneedle Patch for Psoriasis Therapy. Int J Nanomedicine. 2023 Feb 18;18:899-915. doi: 10.2147/IJN.S394957. eCollection 2023.

    PMID: 36824414BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

ClobetasolOintments

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BetamethasoneSteroids, FluorinatedSteroidsFused-Ring CompoundsPolycyclic CompoundsDosage FormsPharmaceutical Preparations

Study Officials

  • John Benjamin B Gochoco, MD

    Dr. Jose N. Rodriguez Memorial Hospital and Sanitarium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2024

First Posted

August 15, 2024

Study Start

January 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 16, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

The whole study will be available

Shared Documents
STUDY PROTOCOL
Time Frame
1 year
Access Criteria
Access to all

Locations

PH(1)