Comparison of the simultaneous effect of oral administration of clobetasol lotion and cyclosporine with the clobetasol lotion alone in the treatment of lichen plano pilaris
The effect of cyclosporine alone on the treatment of lichen planulopathy
Design
The cases were selected randomly from among patients with Lichen Plano-Pillars referred to Razi Hospital
Settings and conduct
Patients in Razi Hospital respond to questioner's questions
Participants/Inclusion and exclusion criteria
All patients with lichen planulus disease
Intervention groups
A study was conducted to evaluate the efficacy of cyclosporine / clobetasol and the clovertaseol group alone, and finally, a comparison was made between the effects of these two groups.
Main outcome variables
regrowing of hair in areas of hair loss if the patient is at an early stage of the disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181112041620N1
Registration date:2019-03-12, 1397/12/21
Registration timing:retrospective
Last update:2019-03-12, 1397/12/21
Update count:0
Registration date
2019-03-12, 1397/12/21
Registrant information
Name
ensieh yousefi Abdolmaleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8803 2269
Email address
ensiehyousefi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-01, 1397/06/10
Expected recruitment end date
2019-01-05, 1397/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the simultaneous effect of oral administration of clobetasol lotion and cyclosporine with the clobetasol lotion alone in the treatment of lichen plano pilaris
Public title
Effect of cyclosporine on hair loss of lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with lichen plano pilaris disease at Razi Hospital
Age limits of 15 to 40 years
Exclusion criteria:
Must be at least one month from the initial referral of these patients to the hospital
Age
From 15 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
To conduct this research, referrals to Razi Hospital in Tehran who have Lpp disease, diagnosed as one month old and ranged from 15 to 70 years old, were randomly assigned 40 individuals individually And by hiding the drug using the spss analysis software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, the method of double-blind study was used and the patients and primary investigators of the questioner were completely unaware of the treatment method.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Mulla Sadra Street- North Shirazi Ave. - East Saeb Street - No. 216
City
Tehran
Province
Tehran
Postal code
1111111111
Approval date
2018-08-21, 1397/05/30
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.341
Health conditions studied
1
Description of health condition studied
Lichen planopilaris
ICD-10 code
L67
ICD-10 code description
Hair color and hair shaft abnormalities
Primary outcomes
1
Description
Plano Polaris's patients percentage
Timepoint
60days
Method of measurement
Therapeutic questions from the patient
Secondary outcomes
1
Description
Patients may also experience minor problems such as scaling and atrophy due to drug use
Timepoint
30 days
Method of measurement
Random selection of patients and therapist's questions
Intervention groups
1
Description
A lotion of clobetasol as a nosebleed topical steroid once at 30 drops for at least six months
Category
Placebo
2
Description
Oral ciclosporin at a dose of 1 to 3 mg / kg daily plus 30 drops of topical clobetasol lotion every night for 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi's Hospital of Tehran
Full name of responsible person
Dr. Robabeh Abedini
Street address
hran - Vahdat Islami St. - Islamic Unity Square - Razi's Death Row - Razi Skin Specialist Hospital
City
Tehran
Province
Tehran
Postal code
11996639
Phone
+98 21 5563 0174
Email
razihospital@sina.tums.ac.ir
Web page address
Https://razihos.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zohreh Ghodsi
Street address
Tehran, Keshavarz Blvd., Corner of Ghods St, Central Office of Tehran University of Medical Sciences, Seventh Floor
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
20
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
Ensiyeh Yousefi Abdolmaleki
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Tehran Province, Tehran, District 12, Islamic University of Wahdat-e-Islami St.
City
Tehran
Province
Tehran
Postal code
11111-11111
Phone
+98 21 5560 9951
Email
ensiyehyousefi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Vahidesadat Lajevardi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Tehran - Vahdat Islami St. - Islamic Unity Square - Razi's Death Row - Razi Skin Specialist Hospital
City
Tehran
Province
Tehran
Postal code
۱۱۹۹۶۶۳۹۱۱
Phone
+98 21 5563 0174
Email
razihospital@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ensiyeh Yousefi Abdolmaleki
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Mollasadra street. North Shiraz Street. Oriental Saib Alley. 216 apartments
City
Tehran
Province
Tehran
Postal code
11111-11111
Phone
+98 21 8803 2269
Email
Ensiehyousefi@gmail.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