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studing the therapeutic effect of baricitinib and its side effects in LPP (Lichen Plano Pilaris)

studing the therapeutic effect of baricitinib and its side effects and comparing it with clobetasol in LPP (Lichen Plano Pilaris)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221101056374N1
Enrollment
22
Registered
2022-11-15
Start date
2022-12-22
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lichen planopilaris. Chapter XII Diseases of the skin and subcutaneous tissue(L00-L99)

Interventions

Intervention 1: Intervention group: tablet baricitinib 4 miligram daily oral intake. Intervention 2: Control group: clobetasol topical lotion 0.05% once daily ,topical.

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age between 15 and 70 years Acceptance of all provisions of informed consent regarding the plan Absence of contraindications for baricitinib use, including chronic renal failure with GFR below 30, severe liver failure, sensitivity to baricitinib, severe anemia with hemoglobin below 8, lymphopenia with an absolute lymphocyte count below 500, or neutropenia with an absolute neutrophil count below 1000, pregnancy and breastfeeding Not being pregnant and not taking OCP Severe and expanding multifocal disease that is a candidate for receiving systemic medication according to the opinion of the main executive of the plan. Not taking drugs that interact with baricitinib The patient's consent to enter the plan

Exclusion criteria

Exclusion criteria: For any reason, the patient does not agree to enter the plan For any reason, the patient does not agree with the provisions of informed consent in the plan Contraindications to baricitinib use include chronic renal failure with GFR below 30, severe liver failure, sensitivity to baricitinib, severe anemia with hemoglobin below 8, lymphopenia with an absolute lymphocyte count below 500, or neutropenia with an absolute neutrophil count below 1000, pregnancy and breastfeeding Pregnancy or OCP consumption Local and limited disease that is not a candidate for receiving systemic and immunosuppressive drugs according to the opinion of the main executive of the plan. Taking drugs that interfere with baricitinib

Design outcomes

Primary

MeasureTime frame
Percentage reduction of LICHEN PLANOPILARIS ACTIVITY INDEX score. Timepoint: At the beginning of the study (before the start of the intervention) and 2, 4 and 6 months after the start of the study. Method of measurement: Lichen planopilaris disease activity index questionnaire.

Secondary

MeasureTime frame
Aspartate aminotransferase. Timepoint: The beginning of the study (before the start of the intervention) and 2, 4, and 6 months after the start of the study. Method of measurement: blood test.;Alanine aminotransferase. Timepoint: The beginning of the study (before the start of the intervention) and 2, 4, and 6 months after the start of the study. Method of measurement: blood test.;Alkaline phosphatase. Timepoint: The beginning of the study (before the start of the intervention) and 2, 4, and 6 months after the start of the study. Method of measurement: blood test.;Creatinine. Timepoint: The beginning of the study (before the start of the intervention) and 2, 4, and 6 months after the start of the study. Method of measurement: blood test.;Blood urea nitrogen. Timepoint: The beginning of the study (before the start of the intervention) and 2, 4, and 6 months after the start of the study. Method of measurement: blood test.;Complete blood count. Timepoint: The beginning of the study (before the start of the intervention) and 2, 4, and 6 months after the start of the study. Method of measurement: blood test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFateme Ghaseminia

Tehran University of Medical Sciences

f.ghaseminia@gmail.com+98 913 350 1258

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026