Compression of the Efficacy and safety of Rhofanib® (Tofacitinib) with placebo in the symptom control and improvement of hair loss in patients with lichen planopilaris
Efficacy and safety evaluation of Rhofanib® (Tofacitinib) in the treatment of lichen planopilaris
Design
A concealed, randomized, double-blind, phase 4 placebo controlled clinical trial with a parallel group design of 48 patients. Randomisation was performed by online sealed envelop site with concealed randomisation sequence.
Settings and conduct
This study will be conducted in 3 referral dermatology centers in Tehran, Iran. All participants are blinded to the allocation of drug or placebo. Additionally, physicians who prescribe drugs, who evaluate outcomes and collect and analyze data are blinded, too.
Participants/Inclusion and exclusion criteria
Signing informed consent
Biopsy confirmed lichen planopilaris
Age between 18-55
LPPAI>5
Women with reproductive potential who had accepted to use effective contraception during the study period
Intervention groups
One group receives Rhofanib (Tofacitinib) 5mg twice a day with concurrent topical clobetasol for 6 months and then will be followed for 3 months after cessation of treatment.
The other group receives Placebo with concurrent topical clobetasol for 6 months and then will be followed for 3 months after cessation of treatment.
Main outcome variables
Lichen Planopilaris Activity Index (LPPAI):
Pruritus
Pain
Burning
Erythema
Perifullic erythema
Perifollicular scale
Pull test: anagen/ total
Spreading
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200107046041N2
Registration date:2020-08-21, 1399/05/31
Registration timing:prospective
Last update:2020-08-21, 1399/05/31
Update count:0
Registration date
2020-08-21, 1399/05/31
Registrant information
Name
Hamideh Moravej farshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1507
Email address
hamidehmoravej@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compression of the Efficacy and safety of Rhofanib® (Tofacitinib) with placebo in the symptom control and improvement of hair loss in patients with lichen planopilaris
Public title
Efficacy and safety evaluation of Rhofanib® (Tofacitinib) in the treatment of lichen planopilaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signing informed consent form
Biopsy confirmed lichen planopilaris
Age between 18-55
LPPAI>5
Women with reproductive potential who had accepted to use effective contraception during the study period
Exclusion criteria:
More than 20% scalp involvement
Concurrent alopecia areata
Current malignancies
History of malignancies in the past 5 years
Active infection
Pregnancy and lactation
Use of systemic drugs such as systemic corticosteroids, cyclosporine, hydroxychloroquine, mycophenolate mofetil in the past 3 months
Hypersensitivity to tofacitinib or any components of its formulation
Latent TB
Hepatitis B and/or C infections
Bone marrow suppression (Hb<9g/dl, ANC<1000 cells/mm3, Lymphocyte<500 cells/mm3)
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups:
The randomization plan of the patients will be carried out using an on-line system (https://www.sealedenvelope.com/). Using permuted block randomization (length of each block is 4) will be made, for a total of 48 patients (with 1:1 allocation ratio).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, main investigator, physicians who prescribe drugs or placebo, those who collect data, and evaluate the outcomes are all blinded to each study group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Research Ethics Committee Skin Research Center-Shahid Beheshti University of Medical S
Street address
Skin Research center, Shohada-e-Tajrish hospital, Shahrdari street, Tajrish square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2020-05-04, 1399/02/15
Ethics committee reference number
IR.SBMU.SRC..REC.1399.003
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
Lichen Planopilaris Activity Index (LPPAI)
Timepoint
Baseline, months 1, 3, 6 and 9
Method of measurement
Lichen Planopilaris Activity Index (LPPAI): Pruritus Pain Burning Erythema Perifullic erythema Perifollicular scale Pull test: anagen/ total Spreading
Secondary outcomes
1
Description
Patients quality of life
Timepoint
Baseline, months 1, 3, 6 and 9
Method of measurement
Dermatology quality of life questionnaire
2
Description
Adverse events
Timepoint
Baseline, months 1, 3, 6 and 9
Method of measurement
Patients self report, physicians observation and lab test abnormalities
Intervention groups
1
Description
Intervention group: this group receives Rhofanib (Tofacitinib) 5mg twice a day with concurrent topical clobetasol for 6 months and then will be followed for 3 months after cessation of treatment.
Category
Treatment - Drugs
2
Description
Control group: This group receives Placebo with concurrent topical clobetasol for 6 months and then will be followed for 3 months after cessation of treatment.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this 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 patient information can be shared without naming and identifying them.
When the data will become available and for how long
Details of the data are immediately available after publishing the results.
To whom data/document is available
All researchers and health professionals working in academic, scientific and medical institutions.
Under which criteria data/document could be used
The data is only shared for person whose purpose is to improve the therapeutic course of Lichen Planopilaris. Any The type of statistical analysis can be done in order to improve the treatment.
From where data/document is obtainable
Shahid Beheshti University of Medical Sciences assistant professor Sahar Dadkhahfar, sahar.dadkhahfar@sbmu.ac.ir, Skin research center, Shohada-e-Tajrish hospital, Tehran, Iran.
00982122741507
What processes are involved for a request to access data/document
Information is available immediately after verifying that the applicant's circumstances are met by the competent authorities.