The aim of this study is comparing therapeutic effect of low-dose low molecular weight heparin (enoxaparin) versus oral prednisone in patients with disseminated lichen planus. Study population: patients with disseminated lichen planus referred to clinic with no prohibition of drugs or immediate needs for treatment with steroids. Exclusion criteria are severe side effects. The sample size was calculated 23 patients in each group. Patients are randomly divided in two groups. In one group subcutaneous enoxaparin 5 mg is weekly prescribed and in another group patients are treated with 0.5mg/kg prednisone orally daily until complete remission or a maximum of 8 weeks. The results of itching severity according visual analogue scale (VAS), extent of active lesions and drug side effects are compared. In remission, patients are followed for 6 months for recurrent lesions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012122211841N1
Registration date:2013-01-18, 1391/10/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-18, 1391/10/29
Registrant information
Name
Ahmad Saeidi
Name of organization / entity
Isfahan university of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 31 1232 2355
Email address
ah_saeidi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan university of medical sciences
Expected recruitment start date
2010-02-21, 1388/12/02
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effect of low-dose low-molecular-weight heparin (enoxaparin) vs. oral prednisone in treatment of patients with lichen planus
Public title
Enoxaparin in treatment of lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with disseminated lichen planus at least 6 months represent to the clinic. Exclusion criteria: 1. Contraindications of heparin and its derivatives, including: hemostasis, acquired or congenital disorder, the risk of bleeding caused by uncontrolled hypertension, active peptic ulcer, recent cerebrovascular accident, sensitivity to enoxaparin or heparin derivatives; 2. Chronic liver disease; 3. Hepatitis B and C; 4. Contraindications for taking oral prednisone; 5. Medications that are known to lead to the LP like reaction; 6. Lichen planus of nails; 7. Scalp involvement; 8. Ulcerated mucosal lesions; 9. Heparin therapy complications such as drug sensitivity, acute bleeding.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University Of Medical Sciences
Street address
Isfahan University Of Medical Science, Hezar jarib st.
City
Isfahan
Postal code
Approval date
2010-02-21, 1388/12/02
Ethics committee reference number
389089
Health conditions studied
1
Description of health condition studied
lichen planus
ICD-10 code
L43.3
ICD-10 code description
lichen planus tropicus
Primary outcomes
1
Description
pruritus
Timepoint
befor treatment-weekly in treatment period- in 1,3 and 6 months following end of treatment
Method of measurement
visual analogue scale(VAS)
2
Description
extention of active lesions
Timepoint
befor treatment-weekly in treatment period- in 1,3 and 6 months following end of treatment
Method of measurement
percentage of skin surface
Secondary outcomes
1
Description
bleeding
Timepoint
weekly in period of treatment
Method of measurement
Observation (yes or no)
2
Description
hypersensitivity
Timepoint
weekly in period of treatment
Method of measurement
Observation (yes or no)
Intervention groups
1
Description
control:The standard treatment of oral prednisolone 0.5 mg per kg daily until complete recovery or up to 8 weeks
Category
Treatment - Drugs
2
Description
intervention: enoxaparin 5 mg subcutaneously weekly until complete remission or a maximum of 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic of Azahra hospital
Full name of responsible person
Ahmad Saeidi
Street address
Dermatology clinic, Azahra hospital, sofe st.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Administrative and Financial of Medical School
Full name of responsible person
Dr. Ebrahim Esfandiari
Street address
Vice chancellor for Administrative and Financial of Medical School-Isfahan University Of Medical Science, Hezar jarib st.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Administrative and Financial of Medical School
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Saeidi
Position
MD, resident of dermatology
Other areas of specialty/work
Street address
Department of Dermatology, School Of Medicine, Isfahan University of Medical Sciences, Hezar jarib st.
City
Isfahan
Postal code
Phone
+98 31 1232 2355
Fax
Email
ah_saeidi@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Saeidi
Position
MD, Resident of dermatology
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar jarib st.