Effect of oral methotrexate and oral prednisolone in Lichen planopilaris

Comparative efficacy study of oral methotrexate and oral prednisolone versus oral methotrexate in Lichen planopilaris patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190911044742N1

Enrollment

Registered

2020-01-19

Start date

2018-02-20

Completion date

Unknown

Last updated

2020-02-24

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

Conditions

Lichen planopilaris. Lichen planopilaris

Interventions

Intervention 1: Control group: Methotrexate 15 mg per week (2.5 mg tablets 6 number). Intervention 2: Intervention group: Methotrexate 15 mg per week and pulse prednisolone 200 mg per week (50 mg tab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Scalp involvement more than 10% ( New cases and resistant to topical therapy cases) Localized scalp involvement (less than 10%) resistant to systemic and topical therapy

Exclusion criteria

Exclusion criteria: Pregnancy and lactation Hemoglobin < 9 mg/ dl Leukocyte < 4000 Platelet < 100000 Liver enzymes higher than 2 fold normal range Positive hepatitis viral test Diabetes Hypothyroidism and hyperthyroidism Severe hypertension Heart failure Active infection Nephropathy Peptic ulcer

Design outcomes

Primary

Measure	Time frame
Pruritis. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Asking patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3).;Pain. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Asking patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3).;Soreness. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Asking patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3).;Erythema. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Examining patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3).;Peri follicular erythema. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Examining patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3).;Peri follicular scale. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Examining patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3).;Spreading. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Examining patient ( No Spreading = 0 Indeterminate = 1 Presence of Spreading = 2).;Anagen pull test. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Examining patient: No Anagen Hairs = 0 Presence of Anagen Hairs = 1.;7-point scale bases on pre treatment and post treatment photography. Timepoint: Base line and at 6 months. Method of measurement: scoring based on pretreatment and post treatment photographs: (Greatly decreased = -3Moderately decreased = -2Slightly decreased = -1No change = 0Slightly increased = +1Moderately increased = +2Greatly increased = +3Don’t know = Technical issues with the photographs did not for accurate evaluation).	—

Measure

Time frame

Pruritis. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Asking patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3).;Pain. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Asking patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3).;Soreness. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Asking patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3).;Erythema. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Examining patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3).;Peri follicular erythema. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Examining patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3).;Peri follicular scale. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Examining patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3).;Spreading. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Examining patient ( No Spreading = 0 Indeterminate = 1 Presence of Spreading = 2).;Anagen pull test. Timepoint: Baseline and at 2,4,6 months. Method of measurement: Examining patient: No Anagen Hairs = 0 Presence of Anagen Hairs = 1.;7-point scale bases on pre treatment and post treatment photography. Timepoint: Base line and at 6 months. Method of measurement: scoring based on pretreatment and post treatment photographs: (Greatly decreased = -3Moderately decreased = -2Slightly decreased = -1No change = 0Slightly increased = +1Moderately increased = +2Greatly increased = +3Don’t know = Technical issues with the photographs did not for accurate evaluation).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarifteh Esfahanian

Esfahan University of Medical Sciences

farifteh_165@yahoo.com+98 31 3627 9010

Outcome results

None listed

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