The aim of this study is to evaluate the effect of adding oral minoxidil to standard anti-inflammatory therapy in the treatment of patients with lichen planoplaris
Design
This study is a randomized clinical trial and patients are randomly divided into two groups of methotrexate and oral minoxidil with methotrexate by random allocation software
Settings and conduct
Two groups of 17 people are selected from the patients referred to the dermatology clinic. After the patient is examined for 3 (LPPAI score, photography and dermoscopy) and the results are recorded, treatment begins
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients between the ages of 18 and 65 who have just been diagnosed and have not yet received treatment.
Patients who have previously been treated and whose disease is still active according to clinical and dermoscopic criteria
Patients should have discontinued any previous systemic medication 1 month prior to enrollment and should not use any systemic or topical medications at the time of the study.
Conditions for not entering the study are:
Pregnancy or breastfeeding
2-leukocytes <3000
3-platelets <100000
4-Hemoglobin <9
5. Liver enzymes more than 2 times the reference limit
6. Positive hepatitis V tests
7- History of cardiovascular diseases and hypotension
8- History of arrhythmia (non-sinus rhythm in ECG)
Intervention groups
After obtaining the consent, one group will be treated with 15 mg of methotrexate weekly and the other group will be treated with 1 mg of minoxidil tablets with 15 mg of methotrexate for 6 months
Main outcome variables
Lichen planoplaris disease activity index is calculated and standard and dermoscopic general imaging is performed in all patients in months 0, 2, 4 and 6, then the results of the two groups before and after treatment are compared
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220528055005N1
Registration date:2022-06-03, 1401/03/13
Registration timing:prospective
Last update:2022-06-03, 1401/03/13
Update count:0
Registration date
2022-06-03, 1401/03/13
Registrant information
Name
Shaghayegh Dehghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 8644
Email address
sh_dehghanii@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of adding oral minoxidil to standard anti-inflammatory therapy in the treatment of patients with lichen planopilaris
Public title
Effect of oral minoxidil in treatment of lichen planopilaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Newly diagnosed patients who have not yet received treatment.
Patients who have previously been treated and whose disease is still active according to clinical and dermoscopic criteria
Patients should have discontinued any previous systemic medication 1 month before entering the study and should not use any systemic or topical medication at the time of the study
Exclusion criteria:
pregnancy or breastfeeding
Leukocytes <3000
Platelets <100000
Hemoglobin <9
Liver enzymes more than 2 times the reference limit
Positive for viral hepatitis tests
History of cardiovascular disease and hypotension
History of arrhythmia (non-sinus rhythm on ECG)
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups of methotrexate and oral minoxidil with methotrexate by random allocation software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of IsfahanUniversity of Medical Sciences
Street address
No 38 ،second Alley، Mollasadra Ave
City
Isfahan
Province
Isfehan
Postal code
8168613446
Approval date
2022-05-25, 1401/03/04
Ethics committee reference number
IR.MUI.MED.REC.1401.086
Health conditions studied
1
Description of health condition studied
Lichen planopilaris
ICD-10 code
L66.1
ICD-10 code description
Follicular Lichen Planus
Primary outcomes
1
Description
Lichen planopilaris activity index
Timepoint
Befor and after intervention
Method of measurement
Cheklist
2
Description
standardized global photography
Timepoint
Befor and after intervention
Method of measurement
Based on scoring by two dermatologist
3
Description
Dermoscopy
Timepoint
Befor and after intervention
Method of measurement
Chcklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Methotrexate ( 15 mg/week orally in one day) will be administered in one group ( 17 patients) and for 6 months
Category
Treatment - Drugs
2
Description
Intervention group: Minoxidil 1 mg tablet in addition to methotrexate 15 mg weekly administered in the other group of 17 people for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr shaghayegh dehghani
Street address
Dermatology Department، Alzahra hospital، Sofe street ،Isfahan
City
Isfahan
Province
Isfehan
Postal code
8168513446
Phone
+98 31 3668 8644
Email
sh_dehghanii@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mozhgan Mortazavi
Street address
Vice Chancellor for research، Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8168613446
Phone
+98 31 3668 8644
Email
sh_dehghanii@yahoo.ccom
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
Dr Shaghayegh dehghani
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology ،Alzahra hospital، Sofe street
City
Isfahan
Province
Isfehan
Postal code
8168613446
Phone
+98 31 3668 8644
Email
sh_dehghanii@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr shaghayegh dehghani
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology ، Alzahra hospital، Sofe street
City
Isfahan
Province
Isfehan
Postal code
8168613446
Phone
+98 31 3668 8644
Email
sh_dehghanii@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr shaghayegh dehghani
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Department of Dermatology،Alzahra hospital،Sofe street
City
Isfahan
Province
Isfehan
Postal code
8168613446
Phone
000983136688644
Email
sh_dehghanii@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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