Natural Gels for Treatment of Plaque Psoriasis

July 19, 2018 updated by: Secret of Youth

Safety and Efficacy of Natural Gel Combination and Hair Mask of Plant Origin in Patients With Psoriasis: A Randomized, Double-Blind, Placebo (Vehicle) Controlled

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Ramat-almogi
      • Reamat- Gan, Ramat-almogi, Israel, 34793
        • Chaim Sheba Med. center. Dept. Of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects with stable (for at least 6 months), mild to moderate (less than 10% of the skin surface area) plaque psoriasis.
  2. Male and female ≥ 18 years old.
  3. Subject is capable of giving a written informed consent.

Exclusion Criteria:

  1. Subjects treated by topical or photo or systemic anti psoriatic therapy during 4 weeks prior to the study.
  2. Subjects treated with Biological products for psoriasis for the last 3 months prior to starting the present study.
  3. Subjects with any other type of psoriasis but vulgaris (plaque ).
  4. Use of investigational agents < 30 days prior to the study.
  5. Low compliance.
  6. Subjects who are mentally or physically unable to comply with all aspects of the study.
  7. Pregnant women.
  8. Known allergic reaction to fragrance or any ingredient of the test products.
  9. Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis.
  10. A medical condition that may put the patient at a general risk and therefore would prevent participation in the clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: patients
natural gels
Drug: natural gels
whole fruits and vegetables
Other Names:
  • plant origin
Placebo Comparator: subjects
These patients will receive that placebo (vehicle) products.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modified Psoriasis Assessment severity index
Time Frame: up to 16 weeks
up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Secret of Youth

Investigators

  • Principal Investigator: Felix Pavlotzky, MD, Chaim sheba Medical Center, Dept. of Dermatolgy. Tel-Hashomer, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

December 30, 2014

First Submitted That Met QC Criteria

December 31, 2014

First Posted (Estimate)

January 1, 2015

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NGCPP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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