The main objective is to evaluate the efficacy and complications of naltrexone in patients with lichen planopilaris through comparing the response to treatment based on changes in LPPAI scores and the frequency of reported drug-related side effects between study groups after 6 months. The secondary objective will be assessing the effect of naltrexone on ameliorating inflammation (through multiple ESR assays) in patients with lichen planopilaris.
After randomization, baseline assessments including disease activity and ESR will be carried out in the Razi dermatology hospital clinic. Then patients will be given their drugs for the upcoming 2 months for a total duration of 6 months. At 2-month intervals, they will be visited for assessing disease activity, treatment tolerance and complications of treatment. They will be sampled for ESR as well. At the end of the 6 month period, the gathered data will be analyzed. All the assessments and the analysis will be carried out by blinded individuals other than principal investigators.
Participants/Inclusion and exclusion criteria
Patients with the diagnosis of lichen planopilaris will enter the study. Whom with circumstances that interfere with the use of naltrexone will be excluded.
Intervention groups
One group will receive clobetasol ointment plus low-dose oral naltrexone pills (3mg/day) for 6 months. The other group will receive clobetasol ointment plus placebo.
Main outcome variables
Disease activity by lichen planopilaris activity index score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180809040747N1
Registration date:2018-09-02, 1397/06/11
Registration timing:registered_while_recruiting
Last update:2018-09-02, 1397/06/11
Update count:0
Registration date
2018-09-02, 1397/06/11
Registrant information
Name
Fereshteh Salarvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4424 8739
Email address
fsalarvand@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2020-04-03, 1399/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of low-dose naltrexone with placebo in lichen planopilaris: A randomized double-blinded clinical trial
Public title
The effect of naltrexone in lichen planopilaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Lichenplanopilaris (LPP) based on pathology
Exclusion criteria:
Burn-out lesions
Any treatments for lichenplanopilaris within the last month
History of drug addiction or alcohol abuse
History of psychiatric disorders
Willing to get or being pregnant
Consumption of drugs interfering with naltrexone (e.g. opioid antagonists)
Generalized cutaneous or mucosal lichen plan
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to any of two groups by 4-spot permuted blocks with 1:1 ratio
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants are blinded by using identical placebos (in shape, package, and flavor). The principal investigator who assesses efficacy and individuals who assess safety are also blinded to assignment. The analyzer is blinded.
Placebo
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 Central Building, Qods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2018-03-10, 1396/12/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.4753
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 Acivity Index (LPPAI) Score
Timepoint
before intervention and 2, 4 , 6 months after intervention
Method of measurement
LPPAI Questionnair
Secondary outcomes
1
Description
Treatment tolerance
Timepoint
2, 4 and 6 months after intervention
Method of measurement
Interview
2
Description
ESR
Timepoint
Before intervention and 2, 4 and 6 months after intervention
Method of measurement
Lab kit
Intervention groups
1
Description
Intervention group: Oral tab naltrexone 3mg once a day at 1 hr before sleep plus topical Clobetasol ointment once at night for 6 months
Category
Treatment - Drugs
2
Description
Control group: Oral Tab Placebo once a day at 1 hr before sleep plus topical clobetasole ointment once a day at night for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Dermatology Hospital
Full name of responsible person
Vahideh Lajevardi
Street address
Vahdat-e-Eslami Street
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 3949
Email
razihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
Qods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?