Determination about efficacy of Gracilaria algae topical cream in comparison with Clobetasol cream in treatment of plaque type psoriasis
Design
triple blind,randomized controlled clinical trial with a group design of 30 patients enrolled between 2019-2020
Settings and conduct
30 patients who has been visited Alzahra and Sedighe Tahere dermatology clinics will be the population of interest.One person out of study who is aware of components; allocate A or B code to gracilaria algae or clobetasol creams that patients, investigators, dermatologist and data analyser are unaware of contents of A or B creams.patients who have met all of the following criteria of study; have been asked to use topical creams of Gracilaria algae and clobetasol which is allocated randomized A or B code to them to one of the left or right symmetric plaques once daily for 2 months; also not using another treatment of psoriasis during study.
Participants/Inclusion and exclusion criteria
inclusion criteria:
mild to moderate plaque type psoriasis; less than 20 percent body involvement with at least 2 symmetric plaques; age between 20 to 60
exclusion criteria:
pregnancy; lactation; liver and kidney failure
Intervention groups
patients who have met all of the following criteria of study; have been asked to use topical creams of Gracilaria algae and clobetasol which is allocated randomized A or B code to them to one of the left or right symmetric plaques once daily for 2 months; also not using another treatment of psoriasis during study.
Main outcome variables
Psoriasis area and severity index(PASI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191112045423N1
Registration date:2020-01-31, 1398/11/11
Registration timing:registered_while_recruiting
Last update:2020-01-31, 1398/11/11
Update count:0
Registration date
2020-01-31, 1398/11/11
Registrant information
Name
Mohammad Ali Shahtalebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3465 0038
Email address
safoorbk@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-14, 1398/09/23
Expected recruitment end date
2020-03-13, 1398/12/23
Actual recruitment start date
2019-12-20, 1398/09/29
Actual recruitment end date
2020-03-19, 1398/12/29
Trial completion date
2020-03-19, 1398/12/29
Scientific title
Design, Formulation, physicochemical evaluation and clinical trial of Gracilaria algae topical cream for treatment of plaque type Psoriasis
Public title
Effect of topical cream of Gracilaria algae in treatment of plaque type Psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate plaque type psoriasis include atleast 2 symetric plaques
involvement of less than 20 percent of body surface
age limitation between 20 to 60 years old
free and informed written consent for participating in study
2 plaques larger than 2 cm x 2 cm size and maximum 15 cm x 15 cm size with at least 5 cm distance between 2 plaques.
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method is done with Saghayi randomization software for each symmetric plaques in each person randomly allocate different side of plaques (left or right) to treatment drug(Clobetasol cream) and interventional drug(Gracilaria algae topical cream) which is allocated A or B code to them in blinding description.
Blinding (investigator's opinion)
Triple blinded
Blinding description
After design and formulation of Clobetasol creams and Gracilaria algae topical creams which are similarized for Organoleptic properties like color and odor, they will be packaged in same containers.One person out of study will dedicate A or B code to Clobetasol creams or Gracilaria algae topical creams while participants, investigators, Dermatologist and data analyzer are not aware of content of A or B creams during study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Technology Deputy of Isfahan University of Medical Sciences
Street address
Research and Technology Deputy of Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-12-14, 1398/09/23
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.519
Health conditions studied
1
Description of health condition studied
Plaque type Psoriasis
ICD-10 code
L40.8
ICD-10 code description
Other psoriasis
Primary outcomes
1
Description
PASI(psoriasis area and severity index)
Timepoint
4 and 8 weeks after using creams
Method of measurement
Dermatologist opinion based on PASI score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: gracilaria algae topical cream 3% which is made in Dr.Shahtalebi laboratory in Isfahan,once daily for 2 months,topical,one of the symmetric plaques in each patients consider intervention group.
Category
Treatment - Drugs
2
Description
Control group: clobetasol topical cream 0.05%,once daily for 2 months,topical,one of the plaques in each patients consider control group.