efficacy and safety of adding oral pioglitazone to standard treatment in lichen planopilaris
Design
Clinical trial with a control group, with parallel groups, three blinded, randomized, phase 3 on 30 patients.
Settings and conduct
The study population includes all patients with lichen planopilaris who refer to the dermatology clinic of the academic center.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- A disease that is resistant to treatment. It means that topical treatment along with at least 6 months of treatment has been ineffective.
2- Newly diagnosed patients who have not yet received treatment.
3-.Patients who have been treated before and whose disease is still active.
4-Patients who, for any reason, have discontinued any previous medication 1 month before entering the study and have not used any other medication.
5- Patients between 18 and 50 years old Criteria for not entering the study:
1-Pregnancy or breastfeeding
2- Wbc<3000
3-Platelets <100,000
4-Hemoglobin<9
5-Excessive liver enzymes and active liver disease
6- Positive of viral hepatitis tests
7- Heart failure
8- Type 1 diabetes
9- Allergy to pioglitazone and methotrexate
10- Bladder cancer
11- Tissue edema
Intervention groups
In the group of methotrexate and pioglitazone, MTX dose test is first given in the amount of 15 mg by injection. 1 week later, CBC, liver enzymes and kidney function will be checked. If the tests are normal, the dose of 15 mg weekly systemically along with oral pioglitazone 15 mg daily is started for the patient.
In the systemic methotrexate group, CBC, liver enzymes and kidney function are checked first, MTX is given as in the previous group.
efficacy and safety of adding oral pioglitazone to standard treatment in lichen planopilaris
Public title
efficacy and safety of oral pioglitazone in treatment of lichen planopilaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
a disease that is resistant to treatment. It means that the treatment has been ineffective for at least 6 months.
Newly diagnosed patients who have not yet received treatment.
Patients who have been treated before and whose disease is still active.
Patients who, for any reason, have discontinued any previous medication 1 month before entering the study and have not used any other medication at the time of the study.
Patients between 18 and 50 years old
Exclusion criteria:
Pregnancy or breastfeeding
wbc<3000
platelet<100000
hemoglobin<9
Liver enzymes that are too normal for reference and active liver disease
Positive tests for viral hepatitis
Heart failure
Type 1 diabetes
Allergy to pioglitazone and methotrexate
Bladder cancer
Tissue edema
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
By random allocation software, they are divided into two treatment groups with methotrexate and methotrexate and pioglitazone, and patients are selected by a simple random table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient and the main executive of the plan, those who check the outcome, know that there are two treatment groups, but the assistant of the main executive knows who is in which group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Science
Street address
NO13, between 6 and 8 Vatan alley, East Haft Dast St ,Isfahan town
City
ISFAHAN
Province
Isfehan
Postal code
8164654933
Approval date
2023-04-14, 1402/01/25
Ethics committee reference number
IR.MUI.MED.REC.1402.040
Health conditions studied
1
Description of health condition studied
Lichen planopilaris
ICD-10 code
L66.1
ICD-10 code description
Lichen planopilaris
Primary outcomes
1
Description
Lichen Planopilaris Activity Index
Timepoint
Months 0, 2, 4, and 6 after starting the drug
Method of measurement
Handyscope dermatoskope (FotoFinder System GmbH, Bad Brinbach, Germany
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Methotrexate group with pioglitazone, test dose of MTX is given in the amount of 15 mg by injection. 1 week later, CBC, liver enzymes and kidney function will be checked. If the tests are normal, the dose of 15 mg weekly systemically along with oral pioglitazone 15 mg daily is started for the patient.The minimum duration of treatment and follow-up is 6 months, and follow-up is done in months 0, 2, 4, and 6.
Category
Treatment - Drugs
2
Description
Control group: Methotrexate group, the test dose of MTX is given in the amount of 15 mg by injection. 1 week later, CBC, liver enzymes and kidney function will be checked. If the tests are normal, a weekly dose of 15 mg is started for the patient. The minimum duration of treatment and follow-up is 6 months, and follow-up is done in months 0, 2, 4, and 6.