Psoriasis, an autoimmune and recurrent chronic inflammatory skin disease that is influenced by both genetic and triggers factors. About 1-3% of the world wide 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 current agents.
Based on several studies, verbascum thapsus can inhibit several inflammatory enzymes mainly involved in the inflammatory process of Psoriasis and it has immunomodulator effect. Therefore, we decided to target this well known herbal agent with fantastic safety profile to be formulated as a novel topical ointment 10%. Prior to the formulation, the hydro alcoholic extract of verbascum leaf was obtained following the full process of literature based validated technique.
The clinical and therapeutic benefit of this novel topical formulation was carried out on 25 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) score as well as photos before and after treatment use to evaluate the outcome. The duration of study is at least two month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404093106N16
Registration date:2014-05-12, 1393/02/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-12, 1393/02/22
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
The effect of alcoholic extract of Verbascum thapsus ointment on psoriasis
Public title
Investigation effect of Verbascum thapsus ointment on psoriasis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients older than 18 years old; patients with low-to-severe plaque Psoriasis lesions are symmetric; no other underlying disease or are not pregnant; patients who do not receive treatment or previous treatment for at least two weeks before they are cut.
Exclusion criteria: in case of dissatisfaction and sensitivity; patients who did not complete the treatment process and do not continue; pregnancy and lactation.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Not 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
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
58
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
1. Redness, thickness, scaling and involved area.2. PASI score(psoriasis area & severity index)
Timepoint
Week 0 (baseline), week 3,6,9 to complete the follow-up
Method of measurement
1. Psoriasis questionnaire/ 2. Psoriasis quality of life questionnaire/3. photography: before, during &after treatment/4. 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, Questionnaire, photography, scoring
Intervention groups
1
Description
Herbal ointment: containing 10 % Verbascum thapsus extract in plastibase. patients were instructed to apply the Herbal ointment twice a day.
Category
Treatment - Drugs
2
Description
placebo ointment: containing plastibase. patients were instructed to apply twice a day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomaini hospital
Full name of responsible person
Dr Parvin Mansoori
Street address
Imam Khomeini Hospial complex, Keshavarz blv.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Pharmaceutical Sciences Branch
Full name of responsible person
Dr. Orkideh Ghorban dadras
Street address
No.99, Yakhchal street, Dr. Shariati Avenue Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Pharmaceutical Sciences Branch
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmaceutical science branch of Islamic azad university
Full name of responsible person
Dr. Farshad Hashemian
Position
Assistant professor
Other areas of specialty/work
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
Phone
+98 21 2264 0051
Fax
Email
hashemian.f@iaups.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)