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Comparison of the Effectiveness of Pioglitazone and Clobetasol and their possible adverse effect on patients with Lichen Planopilaris

Protocol summary

Study aim
Assessing the therapeutic effect of pioglitazone and clobetasol and their side effects in patients with lichen planoplaris
Design
phase three, two-arm parallel-group, single-blind randomized control trial. randomization was done using the Block randomization method.
Settings and conduct
The study is conducted in the dermatology clinic of Razi Hospital, Tehran. Enrolled patients are randomly assigned to the intervention or control group using the block randomization method. The patients will be assessed before starting the intervention and in the second, fourth, and sixth months. A dermatologist blinded to the study objectives visits the patients and evaluates the disease's severity using the lichen planopilaris activity index. A blinded statistician unaware of patients allocation will analyze the data.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 15 to 70 years, Written informed consent, no contraindications for pioglitazone (heart failure, COPD, kidney problem, liver problem, diabetes, allergy to pioglitazone ), no pregnancy, and no recent use of OCP, Localized disease ( the patient is not a candidate for systemic or immunosuppressive drugs), a new case with no previous history of drug use, or a known case with flare-up in whom the drug has not been started in the past three months. Exclusion Criteria: Unwillingness to participate, pioglitazone contraindications, pregnancy or OCP use, progressive multifocal disease ( candidate for systemic or immunosuppressive treatment), a known case of LPP and a history of drug use in the past three months, taking drugs interacting with pioglitazone.
Intervention groups
The intervention and the control group received Pioglitazone 15 mg tablets daily and Clobetazole lotion 0.05 every night during the experiment, respectively.
Main outcome variables
the severity of lichen planopilaris based on lichen palonopilaris activity index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210926052596N1
Registration date: 2021-11-11, 1400/08/20
Registration timing: registered_while_recruiting

Last update: 2021-11-11, 1400/08/20
Update count: 0
Registration date
2021-11-11, 1400/08/20
Registrant information
Name
Amir peymanfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6640 5357
Email address
amirpeymanfar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Pioglitazone and Clobetasol and their possible adverse effect on patients with Lichen Planopilaris
Public title
Effect of Pioglitazone and Clobetasol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients between 15-70 years old with lichen planopilaris localized disease in which there was no need for systemic immunosuppressors no pregnancy or history of OCP consumption the patient a new case or was a known case who did not receive medication during the las three months no history of consuming a drug interaction with Pioglitazone no contraindication for Pioglitazone consumption such as diabetes mellitus, heart failure, hypersensitivity reaction to Pioglitazone Assign written informed consent
Exclusion criteria:
Unwillingness to participate pioglitazone contraindications (diabetes, heart failure, COPD, kidney or liver disease, diabetes, allergy to pioglitazone) pregnancy or OCP use progressive multifocal disease ( that is a candidate for systemic or immunosuppressive treatment) known case of LPP and a history of drug use in the past three months taking drugs interacting with pioglitazone.
Age
From 15 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
We will use a random-permuted block for randomization : We assign the different positions to groups 1 to 6. Then, we extract the numbers from the random numbers table and select any of the blocks assigned to these numbers. of note the block sizes were as follows: the first, third, fourth, and eighth blocks each have eight members. The second and fifth blocks have six and four members, respectively
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyzer and the investigator are blind to the randomization grouping and drug administration.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qods , Keshavars Blv,, Tehran Town
City
tehran
Province
Tehran
Postal code
1417613151
Approval date
2020-07-14, 1399/04/24
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.220

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
severity of lichen planopilaris based on lichen palonopilaris activity index
Timepoint
assessing the disease severity before starting the intervention and 2,4, 6 month after starting the medications
Method of measurement
Lichen planopilaris activity index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: those who received 1 tablet of Pioglitazone 15 mg every day till the end of the experiment
Category
Treatment - Drugs

2

Description
Control group: those who received topical Clobetasol lutions 0.05% on their lesions every night till the end of the experiment
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology Clinic in Razi Hospital
Full name of responsible person
Amir Abbas peymanfar
Street address
Vahdat Eslami St., Vahdat Eslami Square, Razi Dermatology Hospital, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
amirpeymanfar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
vice chancellor for research, Qods st., Keshavarz blv., Tehran Town
City
tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6670 6142
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Amir Peymanfar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 8, Hosseini Alley, Lashkarnezhad Alley, Valiasr st., Tehran Town
City
Tehran
Province
Tehran
Postal code
1196734841
Phone
+98 21 5536 7241
Email
amirpeymanfar@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vahide Sadat lajevardi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vahdat Eslami St., Vahdat Eslami Square, Razi Dermatology Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Fax
Email
Vahide_lajevardi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Abbas Peymanfar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 8, Hosseini Alley, Lashkarnexhad Alley, Valiasr st., Tehran Town
City
Tehran
Province
Tehran
Postal code
1196734841
Phone
+98 21 5536 7241
Email
amirpeymanfar@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
No more information is available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be accessible for academic researchers after anonymization.
When the data will become available and for how long
After article publication, the Data will be accessible forever
To whom data/document is available
all academic researchers in the field of medicine and pharmacology
Under which criteria data/document could be used
Just for using in research fields and respecting the original researchers in any referencing
From where data/document is obtainable
Contact with Dr peymanfar using the following email: amirpeymanfar@yahoo.com
What processes are involved for a request to access data/document
Just an Email containing the main researchers' ID and the primary subjective of their study.
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