Systemic Treatment Options for Generalized Lichen Planus

December 17, 2024 updated by: Mohibullah Zahidi, Sheikh Zayed Medical College

Comparison of Efficacy of Oral Methotrexate and Acitretin for Generalized Lichen Planus

Lichen planus is a chronic inflammatory skin condition with unknown etiology. It requires a long term treatment. Evaulating the most efficacious, safe and affordable treatment option is the need of the hour. This study is going to compare the efficacy of two familiar drugs (acitretin and methotrexate) in the treatment of generalized lichen planus as to find out the relatively more effective and safer treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Lichen planus (LP) is a chronic mucocutaneous condition of an unknown cause. It presents clinically as purple, itchy papules and plaques on the lower back, body folds, oral mucosa, and on the scalp(1). It is recurrent condition with a prolonged course and requires an effective, safer and relatively cheaper treatment option (2).

Objective: "To compare the efficacy of oral methotrexate vs. oral acitretin in the treatment of generalized lichen planus".

Material & Methods: This randomized comarative study will be carried out in Outpatient Dermatology Department, Sheikh Zayed Hospital Rahim Yar Khan, Pakistan. Approval of the study has been taken from ethical review committee of the hospital.Data will be collected on prescribed form. Patient will be selected on basis of inclusion & exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will include 124 patients which will be divided into 2 groups A & B, 62 in each group. Group A will receive oral methotrexate 10mg once weekly for 12 weeks. Group B will receive oral acitretin 50mg daily for 12 weeks. Folic acid will be given to all patients in group A at a dose of five milligram per day. Patient will be followed at 4 weekly interval and final efficacy will be determined at 12th week.Data will be analyzed by SPSS v25.0.

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Phase 2

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 Locations

  • Pakistan
    • Punjab
      • Rahim Yar Khan, Punjab, Pakistan, 64200
        • Sheikh zayed Medical College and Hospital
        • Contact:
          • Sheikh zayed Medical college SZMC/H
          • Phone Number: +92689230168
          • Email: info@szmc.edu.pk

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: 18-60 years
  • Gender: both male and female
  • Type of Lichen planus: generalized lichen planus
  • Patients not taking prior treatment in last 1 month

Exclusion Criteria:

  • Pregnancy and lactating females
  • Bleeding disorders
  • Abnormal liver function tests
  • Platelet count less than 100000
  • Hypersensitivity to Methotrexate or Acitretin
  • Unrealistic expectations

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: Oral methotrexate group (Group A)
Patients with generalized lichen planus will be given 10 mg per week
Drug: Methotrexate (drug)
oral methotrexate 10 mg per week for 12 weeks
Active Comparator: Oral Acitretin group (Group B)
Patients with generalized lichen planus will be given oral acitretin 50 mg once daily
Drug: Acitretin
oral acitretin 50 mg once daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of oral methotrexate vs. oral acitretin in the treatment of generalized lichen planus
Time Frame: Clinical assessment for efficacy will be done 4 weekly for 12 weeks.

Efficacy will be assesssed clinically at each follow up visit. Final efficacy of each treatment will be determined at last follow up visit( i.e. at 12 th week after start of treatment).The final efficacy will be divided into following groups on the basis of clinical resolution of disease:

  1. Remission: It is defined as complete resolution of all lesions leaving behind normal skin or post inflammatory pigmentation.
  2. Improvement: It is defined as a more than 50% decrease of the disease, as clinically measured by the surface area from the baseline.
  3. No improvement: It is defined as less than a 50% improvement in the disease, as measured clinically by the surface area from the baseline.
Clinical assessment for efficacy will be done 4 weekly for 12 weeks.

Collaborators and Investigators

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

Sponsor

Sheikh Zayed Medical College

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 (Estimated)

December 10, 2024

Primary Completion (Estimated)

March 15, 2025

Study Completion (Estimated)

March 20, 2025

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SheikhZMC/H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Subscribe