1. Objective: With the purpose of finding a topical treatment with less adverse effect, we design a triple blinded RCT to compare topical corticosteroid as the conventional topical treatment of cutaneous lichen planus with topical phenytoin. 2.Design: Triple blinded randomized control trial without placebo 3. Setting and conduct: diagnosis of the disease was made clinically. 50 patients that were referred to Faghihi hospital was put in 2 groups of phenytoin cream and fluocinolone cream randomly. 4.participents including major eligibility criteria: both sex and all age group can enter the study. Exclusion criteria are pregnant and lactating women, other manifestation of lichen planus, or history of using topical and/or oral corticosteroid in last 1 month and sensitivity to phenytoin or fluocinolone 5. Intervention: patients apply their drug on the lesions twice daily. patients are visited in second, fourth and eighth weeks. 6. Main outcome measures: Patients are evaluated for color, scaling, thickness, and pruritus. all data are recorded by photography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081231028N3
Registration date:2017-08-26, 1396/06/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-26, 1396/06/04
Registrant information
Name
Seyed Mohammad Salar Zaheryani
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 1510
Email address
smszaheryany@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of efficacy of topical phenytoin versus topical flucinolon in treatment of cutaneous lichen planus
Public title
comparison of efficacy of topical phenytoin versus topical flucinolon in treatment of cutaneous lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patients with cutaneous lichen planus visiting at Faghihi Hospital in 2013 - 2018
exclusion criteria: pregnant and lactating woman; use of systemic or topical steroid in last 1 month; sensitivity reaction to phenytoin or fluocinolone; patient has oral, genital, actinic, pigmentosus type of lichen planus; concomitant lichenplanopilaris.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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 Shiraz University of Medical Sciences
Street address
Shiraz University Of Medical Sciences , Zand Street , Shiraz , Iran
City
Shiraz
Postal code
Approval date
2014-07-26, 1393/05/04
Ethics committee reference number
CT_P_9354-5544
Health conditions studied
1
Description of health condition studied
cutaneous lichen planus
ICD-10 code
L43.8
ICD-10 code description
Other lichen planus
Primary outcomes
1
Description
color of lesions
Timepoint
before starting of treatment and 2,4 and 8 weeks after start of treatment
Method of measurement
Physical exam
2
Description
scale
Timepoint
before starting of treatment and 2,4 and 8 weeks after start of treatment
Method of measurement
Physical exam
3
Description
thickness of lesion
Timepoint
before starting of treatment and 2,4 and 8 weeks after start of treatment
Method of measurement
Physical exam
4
Description
pruritus
Timepoint
before starting of treatment and 2,4 and 8 weeks after start of treatment