Psoriasis vulgaris is one the commonest chronic plaque type diseases of the skin in Iran and the world that causes considerable morbidity in patients. One of the systemic treatments is retinoid that acitretin in this group is usually used. One of the side effects of acitretin is teratogenicity till 2 years after stopping it. Since the teratogenicity of isotretinoin remains only 1 month after stopping, if it improves psoriasis vulgaris considerably, it can be used instead of acitretin in the ages of reproduction in females. In this study, the patients with psoriasis vulgaris that are candidates for phototherapy will be chosen and then are randomly divided into 2 groups as intervention and control group. The cases in intervention group are taken isotretinoin (0.5mg/kg) and the controls are taken placebo for 2 weeks and after that NB-UVB is added to treatments in both ones for other 12 weeks. In the regular examinations (First visit, 4 weeks, 10 weeks, and 14 weeks after starting therapy) PASI is calculated for each one and then are compared between groups to determine the efficacy of isotretinoin in the treatment of psoriasis vulgaris.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812213543N1
Registration date:2010-04-24, 1389/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-24, 1389/02/04
Registrant information
Name
Somayeh Khezri
Name of organization / entity
Razi hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 5560 9951
Email address
mortazma@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research of Tehran University of Medical Sciences, Behestan Darou (P.J.S)
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of isotretinoin plus NB-UVB in the treatment of psoriasis vulgaris
Public title
The efficacy of isotretinoin plus NB-UVB in the treatment of psoriasis vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with chronic plaque type psoriasis (psoriasis vulgaris) who are candidates for phototherapy
Exclusion criteria: female patients who do not have a safe contraception or want to become pregnant in less than 1 month, patient with abnormal lipid profile tests, liver function tests and ANA
Age
From 15 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor for Research of Tehran University of Medical Sciences
Street address
Vice-chancellor for Research of Tehran University of Medical Sciences, 205th room, 1st floor, Education Bldg, Poursina st.
City
Tehran
Postal code
1417613151
Approval date
2008-06-26, 1387/04/06
Ethics committee reference number
333
Health conditions studied
1
Description of health condition studied
Psoriasis vulgaris
ICD-10 code
L40.0
ICD-10 code description
psoriasis vulgaris
Primary outcomes
1
Description
Improvement of severity of psoriasis vulgaris
Timepoint
First visit, 4 weeks, 10 weeks, 14 weeks after starting therapy
Method of measurement
PASI score
Secondary outcomes
1
Description
Complications (nausea, pruritus, erythrodermia)
Timepoint
First visit, 4 weeks, 10 weeks, and 14 weeks after starting therapy
Method of measurement
clinical examination
Intervention groups
1
Description
Isotretinoin (0.5mg/kg) for 2 weeks then NB-UVB for 12 weeks