Systemic Treatment Options for Generalized Lichen Planus

NCT06739551 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SheikhZMC/H
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lichen Planus

Keywords

Lichen Planus; Acitretin; Methotrexate; Efficacy

Outcome Measures

Primary Outcomes (1)

• Efficacy of oral methotrexate vs. oral acitretin in the treatment of generalized lichen planus

  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.

Study Arms (2)

Oral methotrexate group (Group A)

ACTIVE COMPARATOR

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

Drug: Methotrexate (drug)

Oral Acitretin group (Group B)

ACTIVE COMPARATOR

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

Drug: Acitretin

Interventions

Methotrexate (drug) DRUG

oral methotrexate 10 mg per week for 12 weeks

Oral methotrexate group (Group A)

Acitretin DRUG

oral acitretin 50 mg once daily for 12 weeks

Oral Acitretin group (Group B)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

Study Sites (1)

Sheikh zayed Medical College and Hospital

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location

MeSH Terms

Conditions

Lichen Planus

Interventions

Methotrexate; Pharmaceutical Preparations; Acitretin

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Terpenes; Pigments, Biological; Biological Factors

Central Study Contacts

Mohibullah, Post graduate resident

CONTACT

+923168716717; mohibzahidi.123@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident in Dermatology

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 18, 2024
• Study Start: December 10, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 20, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)