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Systemic Treatment Options for Generalized Lichen Planus

NCT ID: NCT06739551

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2025-03-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lichen Planus

Keywords

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Lichen Planus Acitretin Methotrexate Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral methotrexate group (Group A)

Patients with generalized lichen planus will be given 10 mg per week

Group Type ACTIVE_COMPARATOR

Methotrexate (drug)

Intervention Type DRUG

oral methotrexate 10 mg per week for 12 weeks

Oral Acitretin group (Group B)

Patients with generalized lichen planus will be given oral acitretin 50 mg once daily

Group Type ACTIVE_COMPARATOR

Acitretin

Intervention Type DRUG

oral acitretin 50 mg once daily for 12 weeks

Interventions

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Methotrexate (drug)

oral methotrexate 10 mg per week for 12 weeks

Intervention Type DRUG

Acitretin

oral acitretin 50 mg once daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheikh Zayed Medical College

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mohibullah Zahidi

Post Graduate Resident in Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheikh zayed Medical College and Hospital

Rahim Yar Khan, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Mohibullah, Post graduate resident

Role: CONTACT

Phone: +923168716717

Email: [email protected]

Facility Contacts

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Sheikh zayed Medical college SZMC/H

Role: primary

Other Identifiers

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SheikhZMC/H

Identifier Type: -

Identifier Source: org_study_id