Natural Gels for Treatment of Plaque Psoriasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02330237|
Recruitment Status : Completed
First Posted : January 1, 2015
Last Update Posted : July 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parapsoriasis||Drug: natural gels Drug: Placebo||Phase 2 Phase 3|
This is a random, double blind placebo -vehicle- controlled study. Patients recruiting and inclusion into the study is well defined. Expert on site monitoring will assure execution of all assignments as detailed in the protocol (screening, consent form, double-blind group assignment) .
- It is calculated that 52 patients will be needed for this study.
- Type I error probability associated with this test is 0.05 .
- Uncorrected chi square will be used to assess changes in the measured variables.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Safety and Efficacy of Natural Gel Combination and Hair Mask of Plant Origin in Patients With Psoriasis: A Randomized, Double-Blind, Placebo (Vehicle) Controlled|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||September 2017|
Active Comparator: patients
Drug: natural gels
whole fruits and vegetables
Other Name: plant origin
Placebo Comparator: subjects
These patients will receive that placebo (vehicle) products.
- Modified Psoriasis Assessment severity index [ Time Frame: up to 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330237
|Chaim Sheba Med. center. Dept. Of Dermatology|
|Reamat- Gan, Ramat-almogi, Israel, 34793|
|Principal Investigator:||Felix Pavlotzky, MD||Chaim sheba Medical Center, Dept. of Dermatolgy. Tel-Hashomer, Israel|