Lichen PlanusPhase 2NCT06739551
Systemic Treatment Options for Generalized Lichen Planus
A Phase 2 study testing Methotrexate (drug) and Acitretin in people with Lichen Planus, run by Sheikh Zayed Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lichen Planus
- What is being tested?
- Methotrexate (drug) and Acitretin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Dec 2024to 20 Mar 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy and lactating females
- Bleeding disorders
- Abnormal liver function tests
- Platelet count less than 100000
- Hypersensitivity to Methotrexate or Acitretin
- Unrealistic expectations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Sheikh zayed Medical College and Hospital
Rahim Yar Khan, Punjab Province, 64200
Sheikh zayed Medical college SZMC/H, +92689230168, info@szmc.edu.pk
About this study
Official title: 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.
Read the 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.
- Conditions
- Lichen Planus
- Being tested
- Methotrexate (drug), Acitretin
- Keywords
- Lichen Planus, Acitretin, Methotrexate, Efficacy
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methotrexate (drug)Drug
oral methotrexate 10 mg per week for 12 weeks
AcitretinDrug
oral acitretin 50 mg once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Oral methotrexate group (Group A) | Active comparator | Patients with generalized lichen planus will be given 10 mg per week Receives: Drug: Methotrexate (drug) |
| Oral Acitretin group (Group B) | Active comparator | Patients with generalized lichen planus will be given oral acitretin 50 mg once daily Receives: Drug: Acitretin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: Clinical assessment for efficacy will be done 4 weekly for 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start10 Dec 2024 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohibullah Zahidi, Sheikh Zayed Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739551
- Sponsor's protocol ID
- SheikhZMC/H
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Oral Methotrexate and Acitretin for Generalized Lichen Planus
- ClinicalTrials.gov ID
- NCT06739551
- Acronym / sponsor ID
- SheikhZMC/H
- Conditions
- Lichen Planus
- Keywords
- Lichen Planus, Acitretin, Methotrexate, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral methotrexate group (Group A) | Active comparator | Drug: Methotrexate (drug)Patients with generalized lichen planus will be given 10 mg per week |
| Oral Acitretin group (Group B) | Active comparator | Drug: AcitretinPatients with generalized lichen planus will be given oral acitretin 50 mg once daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnancy and lactating females
- Bleeding disorders
- Abnormal liver function tests
- Platelet count less than 100000
- Hypersensitivity to Methotrexate or Acitretin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methotrexate (drug)oral methotrexate 10 mg per week for 12 weeks | Drug | Oral methotrexate group (Group A) |
| Acitretinoral acitretin 50 mg once daily for 12 weeks | Drug | Oral Acitretin group (Group B) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-controlled Study.
Lichen Penis Planus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methotrexate (drug) and Acitretin in people with Lichen Planus, run by Sheikh Zayed Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohibullah, Post graduate resident (+923168716717, mohibzahidi.123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.