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

Protocol summary

Study aim
Comparative efficacy study of oral methotrexate and oral prednisolone versus oral methotrexate in Lichen planopilaris patients
Design
Randomized, double blinded, parallel group clinical trial
Settings and conduct
Patients with lichen planopilaris attending to Alzahra Hospital are randomly divided into two groups. patients in control group receive methotrexate 15 mg/week. patients in intervention group receive methotrexate with similar dose as well as pulse prednisolone 200 mg per week. patients are examined at base line, 2, 4 and 6 months and their LPPAI is recorded by a blind examiner and lab data is documented in first months every 2 weeks and then monthly. Standard photography is done at baseline and at month 6 and a blind investigator evaluates them using a 7-point scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with active Lichen planopilaris resistant to other systemic therapy or patients with progressive disease who doesn't have received any treatment for 3 months. exclusion criteria: Diabetes, active infection, abnormal liver enzymes, anemia, leukopenia, thrombocytopenia, severe hypertension, heart failure, pregnancy and lactation
Intervention groups
Control group: patients receiving oral methotrexate ( 15 mg per week) Intervention group: patients receiving oral methotrexate (15 mg per week) and pulse prednisolone ( 200 mg per week)
Main outcome variables
Pruritis, pain, soreness, erythema, peri follicular erythema, peri follicular scale anagen pull test spreading 7- point scales based on pre and post treatment photography

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190911044742N1
Registration date: 2020-01-19, 1398/10/29
Registration timing: retrospective

Last update: 2020-01-19, 1398/10/29
Update count: 0
Registration date
2020-01-19, 1398/10/29
Registrant information
Name
Farifteh Esfahanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5523 4893
Email address
farifteh_165@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2018-12-06, 1397/09/15
Trial completion date
2019-06-05, 1398/03/15
Scientific title
Comparative efficacy study of oral methotrexate and oral prednisolone versus oral methotrexate in Lichen planopilaris patients
Public title
Effect of oral methotrexate and oral prednisolone in Lichen planopilaris
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 28
Actual sample size reached: 25
Randomization (investigator's opinion)
Randomized
Randomization description
Individual randomization, using random number table Each patient will be assigned a number from 01 to 28. Then we randomly choose a spot on the random digit table. we use the first 2 digits of the numbers on the chart (since we have a population of 28 patients) and document the first 14 numbers that are less than 29. Patients with these numbers are allocated to control group. Patients with the next 14 numbers collected from the chart, are allocated to recive methotrexate and prednisolone. Patients are not aware of group allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients receive different drugs but they are not aware of their intervention group. An investigator who examines patients and records data is not aware of patients' interventional 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 Univesity of Medical sciences
Street address
3th level,Aftab apartment bulding,Navid dead end,Yaghob jan alley,Nazar street,Esfahan
City
Isfahan
Province
Isfehan
Postal code
8175785994
Approval date
2019-08-28, 1398/06/06
Ethics committee reference number
IR.MUI.MED.REC.1398.307

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
Pruritis
Timepoint
Baseline and at 2,4,6 months
Method of measurement
Asking patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3)

2

Description
Pain
Timepoint
Baseline and at 2,4,6 months
Method of measurement
Asking patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3)

3

Description
soreness
Timepoint
Baseline and at 2,4,6 months
Method of measurement
Asking patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3)

4

Description
Erythema
Timepoint
Baseline and at 2,4,6 months
Method of measurement
Examining patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3)

5

Description
Peri follicular erythema
Timepoint
Baseline and at 2,4,6 months
Method of measurement
Examining patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3)

6

Description
Peri follicular scale
Timepoint
Baseline and at 2,4,6 months
Method of measurement
Examining patient ( Negative = 0 , + / - = 1 , + = 2 , ++ +++ = 3)

7

Description
Spreading
Timepoint
Baseline and at 2,4,6 months
Method of measurement
Examining patient ( No Spreading = 0 Indeterminate = 1 Presence of Spreading = 2)

8

Description
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

9

Description
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)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Methotrexate 15 mg per week (2.5 mg tablets 6 number)
Category
Treatment - Drugs

2

Description
Intervention group: Methotrexate 15 mg per week and pulse prednisolone 200 mg per week (50 mg tablets 4 number)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Farahnaz Fatemi
Street address
3th level,Aftab apartment bulding,Navid dead end,Yaghob jan alley,Nazar street,Esfahan
City
Isfahan
Province
Isfehan
Postal code
8175785994
Phone
+98 31 3627 9010
Email
farifteh_165@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh haghjooye javanmard
Street address
3th level,Aftab apartment bulding,Navid dead end,Yaghob jan alley,Nazar street,Esfahan
City
Isfahan
Province
Isfehan
Postal code
8175785994
Phone
+98 31 3627 9010
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farifteh Esfahanian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
3th level,Aftab apartment bulding,Navid dead end,Yaghob jan alley,Nazar street,Esfahan
City
Isfahan
Province
Isfehan
Postal code
8175785994
Phone
+98 31 3627 9010
Email
farifteh_165@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farifteh Esfahanian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
3th level,Aftab apartment bulding,Navid dead end,Yaghob jan alley,Nazar street,Esfahan
City
Isfahan
Province
Isfehan
Postal code
8175785994
Phone
+98 31 3627 9010
Email
farifteh_165@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farifteh Esfahanian
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
3th level,Aftab apartment bulding,Navid dead end,Yaghob jan alley,Nazar street,Esfahan
City
Esfahan
Province
Isfehan
Postal code
8175785994
Phone
+98 31 5523 4893
Fax
Email
farifteh_165@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There isn't any more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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