This study is designed as a double blind clinical trial, and the purpose is to compare the efficacy of tacrolimus ointment 0.1 % with fluocinolone ointment in patients with cutaneous lichen planus. 50 patients as groups of 25 subjects will be enrolled from the patients referred to dermatology clinic with a diagnosis of lichen planus. The main Inclusion criteria are: patients older than 2 years and patients with histopathological diagnosis of lichen planus. The exclusion criteria are: sensitivity to medication and pregnant or lactating women. Tacrolimus ointment 0.1 % will be used in the first group and Fluocinolone ointment will be used to treat the second group. Patients will be treated for 12 weeks and they will be visited once a month during this period to follow healing and treatment effects. Patients healing will be defined as the loss of lesions (papules and plaques) and pruritus. Presence of post inflammatory hyperpigmentation is not incompatible with healing. After the treatment period, patients will be followed for 3 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407263566N4
Registration date:2014-08-02, 1393/05/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-02, 1393/05/11
Registrant information
Name
Hamide Azimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
azimih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-05-19, 1393/02/29
Expected recruitment end date
2014-06-19, 1393/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comprative Efficiacy of Tacrolimus 0.1% vs flucinolone onitment in patients with cutaneous lichen planus
Public title
Comprative Efficiacy of Tacrolimus 0.1% vs flucinolone onitment in patients with cutaneous lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with definite diagnose of lichen planus; patients older than 2 years.
Exclusion criteria: the presence of other skin diseases; patients using medication that can cause drug-induced lichen planus; history of drug reaction to steroid or Tacrolimus; pregnant women and lactating mothers; mental retarded or physically disabled patients.
Age
From 2 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Sq.
City
Tabriz
Postal code
Approval date
2014-05-18, 1393/02/28
Ethics committee reference number
9330
Health conditions studied
1
Description of health condition studied
Lichen planus
ICD-10 code
L43
ICD-10 code description
Lichen planus
Primary outcomes
1
Description
The recovery rate of lichen planus lesions
Timepoint
Monthly, up to 6 months
Method of measurement
Clinical observation
Secondary outcomes
1
Description
Treatment complication
Timepoint
Monthly, up to 6 months
Method of measurement
Clinical observation
Intervention groups
1
Description
In the first group Tacrolimus 1% cream will ba applied 2 times daily to cover the entire lesion for 12 weeks.
Category
Treatment - Drugs
2
Description
In the second group flucinolone onitmen will be applied 2 times daily to cover the entire lesion for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Sina Hospital
Full name of responsible person
Esmail Emami
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Ali Reza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Avenue, Daneshgah Square
City
Tabriz
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, Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Esmail Emami
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Dermatology ward, Sina Hospital, Azadi Ave
City
Tabriz
Postal code
Phone
00
Fax
Email
esmailemamikhatab90@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamide Azimi
Position
Dermatologist/Associate professor
Other areas of specialty/work
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Postal code
Phone
00
Fax
Email
hamide-azimi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)