Comparison of the efficacy of topical cyclosporine versus clobetasol lotion in patients with lichen planopilaris (LPP) treated with hydroxychloroquine: a single-blinded randomized clinical trial
Comparing the effectiveness of topical cyclosporine with clobetasol lotion in the treatment of patients with lichen planopilaris treated with hydroxychloroquine
Design
A controlled, parallel, single-blinded, randomized, phase 2-3 clinical trial in 18 patients. Randomized with sealed envelopes.
Settings and conduct
Patients diagnosed with lichen planopillaris treated with hydroxychloroquine are randomly assigned to one of the following two groups: topical cyclosporine 2.5% once daily for 5 months and clobetasol lotion once daily for 5 months. Each patient is re-examined at 1, 3, 5, and 6 months after starting treatment, and at each session, in addition to clinical and dermoscopic imaging, disease severity is determined using LPPAI criteria. The physician evaluating the severity of disease and comparing the clinical and dermoscopic images, as well as the statistical expert, do not know which treatment group the patient is in.
Participants/Inclusion and exclusion criteria
inclusion criteria: patients between 13 and 60 years of age and a histopathologic diagnosis of lichen planopilaris. exclusion criteria: Topical or oral treatment in the last monthThe presence of serious concomitant diseases such as uncontrolled diabetes, uncontrolled hypertension, malignancies, retinal diseases
Intervention groups
group 1: topical cyclosporine, group 2: clobetasol lotion
Main outcome variables
Determining the severity of the disease based on LPPAI (lichen planopilaris activity index)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170809035597N3
Registration date:2022-11-19, 1401/08/28
Registration timing:prospective
Last update:2022-11-19, 1401/08/28
Update count:0
Registration date
2022-11-19, 1401/08/28
Registrant information
Name
Azadeh Goodarzi
Name of organization / entity
Iran University of Medical Sciences (IUMS), Rasool Akram hospital, Department of Dermatology
Country
Iran (Islamic Republic of)
Phone
+98 66502040
Email address
goodarzi.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-26, 1401/09/05
Expected recruitment end date
2022-12-26, 1401/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of topical cyclosporine versus clobetasol lotion in patients with lichen planopilaris (LPP) treated with hydroxychloroquine: a single-blinded randomized clinical trial
Public title
The effect of topical cyclosporine in lichen planus of the hair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients between 13 and 60 years of age
histopathologic diagnosis of lichen planopilaris
Exclusion criteria:
Topical or oral treatment in the last month
The presence of serious concomitant diseases such as uncontrolled diabetes, uncontrolled hypertension, malignancies, retinal diseases
Age
From 13 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
After being selected by available method, patients are divided into two groups by simple randomization, so that among 18 sealed bags, one bag will be randomly selected for each patient. Each bag contains the letter a or b: a for topical cyclosporine and b for clobetasol lotion.
Blinding (investigator's opinion)
Single blinded
Blinding description
The physician who evaluates the severity of the disease and compares the clinical and dermoscopic images, as well as the statistical expert, do not know to which treatment group the patient belongs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-09-19, 1400/06/28
Ethics committee reference number
IR.IUMS.FMD.REC.1400.428
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
disease severity
Timepoint
One, three, five and six months after the start of treatment
Method of measurement
based on LPPAI (lichen planopilaris activity index) criteria
Secondary outcomes
1
Description
physician satisfaction
Timepoint
One, three, five and six months after the start of treatment
Method of measurement
Based on the 5-point physician global assessment score using clinical and dermatoscopic images
2
Description
patient satisfaction
Timepoint
One, three, five and six months after the start of treatment
Method of measurement
Based on the 5-point patient global assessment score
3
Description
tolerability
Timepoint
One, three, five and six months after the start of treatment
Method of measurement
Using a checklist (yes, no)
4
Description
adverse effects
Timepoint
One, three, five and six months after the start of treatment
Method of measurement
Using a checklist
Intervention groups
1
Description
Intervention group 1: Topical cyclosporine 2.5% once a day for 5 months
Category
Treatment - Drugs
2
Description
Intervention group 2: clobetasol lotion 0.05% once a day for 5 months