Natural Gels for Treatment of Plaque Psoriasis

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: Parapsoriasis
• Intervention / Treatment: Drug: Placebo; Drug: natural gels

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	up to 16 weeks

Collaborators and Investigators

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

Study record dates

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: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Parapsoriasis
• Other Study ID Numbers: NGCPP