Lichen planopilaris is a rare disease that can lead to cicatricial alopecia of the scalp if do not diagnosed and treated properly. Because of the potential for causing permanent alopecia and the relative resistance of this disease to treatment, finding cost effective treatment solutions with minimal side effects, maximum improvement in the quality of life and maximum tolerability, really worth to work. Although a number of anecdotal reports as well as review studies have reported acceptable efficacies for both Cellcept and topical steroids for treatment of lichen planopilaris, no clinical trials have been designed so far to compare the effectiveness of these therapeutic options. The main aim of this study is to compare the effectiveness of cellcept with topical lotion of clobetasol for this disease via lichen planopilaris activity index (LPPAI) in a single-blind randomized clinical trial. 54 eligible patients with histologically proved lichen planopilaris without any history of serious medical problems enter the study. the patients are randomly assigned to any of the cellcept or topical clobetasol treatment groups. Patients are evaluated for LPPAI before the treatment and 2, 4 and 6 months following the treatment by a physician blinded to both the medication and stage of therapy. The treatment effectiveness is evaluated by the amount of variation (decrease) of LPPAI.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102111195N1
Registration date:2013-01-27, 1391/11/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-27, 1391/11/08
Registrant information
Name
Azadeh Goodarzi
Name of organization / entity
Medical School, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 0669
Email address
a-goodarzi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2013-01-24, 1391/11/05
Expected recruitment end date
2013-07-27, 1392/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of cellcept and topical lotion of clobetasol for treatment of lichen planopilaris
Public title
Effectiveness of cellcept and topical clobetasol on lichen planopilaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with histologically approved diagnosis of scalp lichen planopilaris who consent to participate in the study
; no history of any kind of treatment for the lichen planopilaris for at least one month before entering the study
; no history of hepatic, renal, cardiac, pulmonary, hematologic, neurologic and malignancies or peptic ulcer diseases.
; no pregnancy or lactation or intention to pregnancy for at least one year following the onset of treatment
; no history of allergies to any of the components of medications
; no erosive mucosal disease, or generalized cutaneous disease.
Exclusion criteria:
; occurrence of treatment complications that are inconsistent with continuation of therapy ( e.g. not resolving by dosage reduction ) or not tolerable by the patient.
; no desire to continue the study by the patients for any reason including no satisfaction of the treatment results
; patients unresponsive to treatment after 3 months of receiving the medication.
Age
From 15 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization method in this study is the quadruple block randomization. Because the physician who evaluates the lichen planopilaris activity index (LPPAI) before, during and after the completion of treatment is blinded to both the treatment stage and the medication received by the patients, the trial is single blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Razi hospital, Vahdat-e-Eslami Sq., Tehran, Iran
City
Tehran
Postal code
00982155609951, 0098
Approval date
2012-09-01, 1391/06/11
Ethics committee reference number
1175/130/د/91
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
Response to treatment
Timepoint
0,2,4,6 Months after the initiation of study
Method of measurement
LPPAI(lichenplanus activity index)
Secondary outcomes
1
Description
CBC,DIFF
Timepoint
For Clobetasol lotion at the beginning of study and for Cellcept 0,2,4,6 months after the initiation of study
Cap cellcept(an immunosuppressive agent as we know it by mycophenolate mofetil) 2gr daily,it has 500mgr capsules which given as 1gr BD or 2gr DAILY for at least 6months,Razi company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Azadeh Goodarzi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Ghods Ave., Keshavarz Blvd., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tehran University of Medical Sciences