Comparison of effect of Simvastatin ointment and Triamsinolone ointment on improvement of psoriatic plaques in 15 patients with chronic plaque psoriasis in a 4 week period.
Aim: Introduction of a drug for treatment of Chronic Plaque Psoriasis, in order to reduce the complications and also to increase efficacy of treatment.
Study design: 15 patients who fulfill the inclusion criteria will be included in the study. Each patient will be given two boxes, one containing Simvastatin ointment 3% and the other containing Triamcinolone ointment 0.05%. Neither the examiner nor the patients know the content of boxes. Each ointment will be applied on a specific lesion twice a day with the same amount. The lesions will be scored according to PASI score three times during the study period, on 0, 7 and 28th day. Evaluation will be done by a dermatologist and pictures will be taken from the lesion in each visit.
Objectives: Evaluation of effect of Simvastatin on treatment of chronic inflammation. Possibility of replacing Simvastatin with current corticosteroid treatments.
Inclusion criteria: Age between 18 and 50years; with diagnosis of chronic plaque psoriasis on extensors surfaces of elbow or knee; Each patient must have at least two symmetric lesions; patient must fill out the inform consent form; Patient must have a negative history of treatment for at least 6 months; Patient must not have chronic debilitating disease.
Exclusion criteria: Allergic reaction to the medication; if he/she is unwilling to continue; plaque is infected before or during treatment.
Intervention: One of the two lesions is randomly chosen to be treated with 3% Simvastatin ointment and the symmetric lesion will be treated with 0.05% Triamcinolone ointment. Each lesion's change will be compared with itself.
Variables: Erythema, scaling, surface area.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122015334N2
Registration date:2014-02-20, 1392/12/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-20, 1392/12/01
Registrant information
Name
Sina Jelodar
Name of organization / entity
Shiraz university of medical science, student research committee
Country
Iran (Islamic Republic of)
Phone
+98 71 1624 8576
Email address
jelodars@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences.
Expected recruitment start date
2013-12-15, 1392/09/24
Expected recruitment end date
2015-08-15, 1394/05/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of Simvastatin ointment and Triamsinolone ointment on improvement of psoriatic plaques in 15 patients with chronic plaque psoriasis in a 4 week period.
Public title
Simvastatin, a drug with immune-modulatory effect.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients arriving at dermatology clinic at Faghihi hospital, with age between 18 and 50years; with diagnosis of chronic plaque psoriasis on extensors surfaces of elbow or knee; Each patient must have at least two symmetric lesions; patient must fill out the inform consent form; Patient must have a negative history of treatment for at least 6 months; Patient must not have chronic debilitating disease.
Exclusion criteria: If patient develops reaction to the drug; if he/she is unwilling to continue the treatment; If the plaque is infected during or before treatment.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical science, ethic committee.
Street address
Ethic committee, Shiraz university of medical science, Zand street, Shiraz, Fars.
City
Shiraz
Postal code
Approval date
2013-12-15, 1392/09/24
Ethics committee reference number
ct-p-92-5218
Health conditions studied
1
Description of health condition studied
Plaque psoriasis
ICD-10 code
L40.0
ICD-10 code description
A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. Psoriatic lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region; the patholog
Primary outcomes
1
Description
scaling
Timepoint
0, 2nd, 4th week.
Method of measurement
The photos will be compared by two dermatologist who are unaware of type of medication for each lesion.
2
Description
Erythema
Timepoint
0, 2nd, 4th week.
Method of measurement
The photos will be compared by two dermatologist who are unaware of type of medication for each lesion.
3
Description
Area
Timepoint
0, 2nd, 4th week.
Method of measurement
The surface area of th lesions will be calculated by two dermatologists by using photos of the lesions. None of the dermatologists know the treatment used for each lesion.
Secondary outcomes
1
Description
Changes in PASI score.
Timepoint
0, 2nd, 4th week.
Method of measurement
According to PASI score by a dermatologist.
Intervention groups
1
Description
Control group: 0.05% Triamcinolone ointment will be applied twice a day on one of the lesions till the end of study.
Category
Treatment - Drugs
2
Description
Treatment group: 3% Simvastatin ointment will be applied on the symmetric lesion, twice a day till the end of study.