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IRCT20191112045423N1 IRCT 2020-01-31 Esfahan University of Medical Sciences Effect of topical cream of Gracilaria algae in treatment of plaque type Psoriasis Design, Formulation, physicochemical evaluation and clinical trial of Gracilaria algae topical cream for treatment of plaque type Psoriasis 2019-12-14 anticipated 30 Complete https://irct.ir/trial/43653 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Plaque type Psoriasis. Intervention 1: 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. Intervention 2: Control group: clobetasol topical cream 0.05%,once daily for 2 months,topical,one of the plaques in each patients consider control group. Yes - There is a plan to make this available What will be shared: Deidentified Ipd collected for the primary outcome related to study will be published. When: starting 6 months after publication To whom: people working in academic institutions Conditions: Descriptive analysis is allowed to report on data if available Where to obtain: Safoora Bokaie; Iran; Isfahan; Isfahan university of medical science; Pharmacy and pharmaceutical science school; email:safoorbk@ymail.com How to obtain: The request is discussed in the Center Committee and after approval, the data is submitted to the applicant over a period of approximately one month. Comments:
public Dr. Mohammad ali shahtalebi
Pharmacy and Pharmeceutical Sciences, Hezar Jerib Avenue, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7001 shatalebi@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Fariba Iraji
Hazrat Sedighe Tahereh Complex, Khorram Ave, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3335 9090 iraji@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 20 years 60 years Both Pregnancy Lactation Renal Failure Hepatitis and Liver Failure Concurrent systemic treatment indication L40.8 Other psoriasis Treatment - Drugs Treatment - Drugs 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. Control group: clobetasol topical cream 0.05%,once daily for 2 months,topical,one of the plaques in each patients consider control group. PASI(psoriasis area and severity index). Timepoint: 4 and 8 weeks after using creams. Method of measurement: Dermatologist opinion based on PASI score. Esfahan University of Medical Sciences Approved 2019-12-14 Research and Technology Deputy of Isfahan University of Medical Sciences Research and Technology Deputy of Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan Isfahan Isfehan Iran (Islamic Republic of)