Clinical Trial: Natural Gels for Treatment of Plaque Psoriasis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
Brief Summary: The aim of the study is to evaluate the safety and the therapeutic activity of the combination of Natural Gel combination and hair mask of plant origin in patients with mild to moderate plaque psoriasis.
Detailed Summary:
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) .
Statistical analysis:
- 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.
Sponsor: Secret of Youth
Current Primary Outcome: Modified Psoriasis Assessment severity index [ Time Frame: up to 16 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Secret of Youth
Dates:
Date Received: December 30, 2014
Date Started: January 2015
Date Completion: December 2016
Last Updated: April 19, 2016
Last Verified: April 2016
