Psoriasis is an autoimmune and recurrent chronic inflammatory skin disease that influenced by both genetic and triggers factors. About 1-3% of the world’s populations regardless of their age are affected. The characteristic features are hyperprolifration of keratinocytes leading to redness, thickening and scaling of epidermis followed with itching and appearance of the lesions which in most cases bother the patients medically and psychologically. Psoriasis is treated with the wide ranges of oral and topical medications; however, major side effects are associated with these agents. Therefore, we were prompted to target this well known herbal agent with fantastic safety profile to be formulated as a novel topical micro emulsion. Prior to the formulation, the hydro alcoholic extract of turmeric rhizomes was obtained following the full process of literature based validation techniques. The clinical and therapeutic benefit of this novel topical formulation was carried out on 36 patients with mild to moderate plaque psoriasis in a double-blind, placebo-controlled clinical trial. The quality of Life (QOL) questionnaire and PASI (psoriasis area & severity index) scores as well as photos before and after treatment were used to evaluate the outcome. The reported side effects were also recorded and were trivial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304203106N13
Registration date:2013-06-11, 1392/03/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-11, 1392/03/21
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University, Pharmaceutical Sciences Branch
Expected recruitment start date
2012-04-06, 1391/01/18
Expected recruitment end date
2012-12-15, 1391/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A double blind, placebo controlled study of standardized hydro-alcoholic extract of Curcuma longa on plaque psoriasis
Public title
Study of standardized hydro-alcoholic extract of Curcuma longa on plaque psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients diagnosed with plaque Psoriasis. both sexes (male and female) with the age group of 18-70 years old; stable patients with discontinued topical treatment for 2 weeks or 2 month for systemic treatments prior to the study.
Exclusion criteria: pregnancy; lactation; patients with severe skin infections or any malignancies; history of allergies to the active ingredient of the product.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
36
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
Islamic Azad University, Pharmaceutical Sciences Branch
Street address
No1, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
1941933111
Approval date
2011-05-02, 1390/02/12
Ethics committee reference number
13993
Health conditions studied
1
Description of health condition studied
psoriasis
ICD-10 code
L40.0
ICD-10 code description
Psoriasis vulgaris
Primary outcomes
1
Description
Redness
Timepoint
Week 0 (baseline), week 3,6,9 to complete the follow-up
Method of measurement
1.Psoriasis questionnaire2.Psoriasis quality of life questionnaire3. photography: before, during &after treatment4. PASI calculator
2
Description
Thickness
Timepoint
Week 0 (baseline), week 3,6,9 to complete the follow-up
Method of measurement
1.Psoriasis questionnaire2.Psoriasis quality of life questionnaire3. photography: before, during &after treatment4. PASI calculator
3
Description
Scaling
Timepoint
Week 0 (baseline), week 3,6,9 to complete the follow-up
Method of measurement
1.Psoriasis questionnaire2.Psoriasis quality of life questionnaire3. photography: before, during &after treatment4. PASI calculator
4
Description
Involved area
Timepoint
Week 0 (baseline), week 3,6,9 to complete the follow-up
Method of measurement
1.Psoriasis questionnaire2.Psoriasis quality of life questionnaire3. photography: before, during &after treatment4. PASI calculator
5
Description
PASI score
Timepoint
Week 0 (baseline), week 3,6,9 to complete the follow-up
Method of measurement
1.Psoriasis questionnaire2.Psoriasis quality of life questionnaire3. photography: before, during &after treatment4. PASI calculator
Secondary outcomes
1
Description
Reported side effects (systemic and local)
Timepoint
Patients were given a telephone number to call during treatment. Patient could report any side effects 24/7 as well as during follow-ups, all the way through the treatment and after completion.
Method of measurement
Vigorous medical examination by the consultant dermatology in week 0,3,6,9 . Side effects Questionnaire, photography
Intervention groups
1
Description
Herbal microemulsion: patients were instructed to apply the Herbal microemulsion of 0.5% curcumin twice a day on plaque lesions.
Category
Treatment - Drugs
2
Description
Placebo: patients were instructed to apply the Placebo microemulsion twice daily on plaque lesions.