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NCT Number: NCT06739551

Systemic Treatment Options 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.

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Key information

Conditions

Lichen Planus Lichenoid Eruptions Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sheikh zayed Medical College and Hospital

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location contact

Sheikh zayed Medical college SZMC/H

CONTACT

[email protected]

+92689230168

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methotrexate (drug)

Drug

oral methotrexate 10 mg per week for 12 weeks

acitretin

Drug

oral acitretin 50 mg once daily for 12 weeks

Primary outcomes

  1. 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:

    • Remission: It is defined as complete resolution of all lesions leaving behind normal skin or post inflammatory pigmentation.
    • Improvement: It is defined as a more than 50% decrease of the disease, as clinically measured by the surface area from the baseline.
    • No improvement: It is defined as less than a 50% improvement in the disease, as measured clinically by the surface area from the baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohibullah, Post graduate resident

CONTACT

[email protected]

+923168716717

Sponsors and collaborators

Lead sponsor

Sheikh Zayed Medical College

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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