Systemic Treatment Options for Generalized Lichen Planus
ConditionLichen Planus
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSheikh Zayed Medical College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnancy and lactating females
Bleeding disorders
Abnormal liver function tests
Platelet count less than 100000
Trial design
Design model
Parallel
Treatments tested in this trial
Methotrexate (drug)
Drugoral methotrexate 10 mg per week for 12 weeks
Acitretin
Drugoral acitretin 50 mg once daily for 12 weeks
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: Oral methotrexate group (Group A)Active comparator 1 intervention
Group B: Oral Acitretin group (Group B)Active comparator 1 intervention
Trial outcomes
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.
Time frame
Clinical assessment for efficacy will be done 4 weekly for 12 weeks.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: