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Natural Gels for Treatment of Plaque Psoriasis

Sponsor
Secret of Youth (Industry)
Overall Status
Completed
CT.gov ID
NCT02330237
Collaborator
(none)
45
Enrollment
1
Location
2
Arms
32
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: natural gels
  • Drug: Placebo
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 :
Jan 1, 2015
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Modified Psoriasis Assessment severity index [up to 16 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chaim Sheba Med. center. Dept. Of Dermatology Reamat- Gan Ramat-almogi Israel 34793

    Sponsors and Collaborators

    • Secret of Youth

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Secret of Youth
    ClinicalTrials.gov Identifier:
    NCT02330237
    Other Study ID Numbers:
    • NGCPP
    First Posted:
    Jan 1, 2015
    Last Update Posted:
    Jul 23, 2018
    Last Verified:
    Jul 1, 2018
    Additional relevant MeSH terms:
    Psoriasis
    Parapsoriasis

    Study Results

    No Results Posted as of Jul 23, 2018