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Trial record 3 of 5 for:    "Parapsoriasis"

Natural Gels for Treatment of Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02330237
Recruitment Status : Unknown
Verified April 2016 by Secret of Youth.
Recruitment status was:  Recruiting
First Posted : January 1, 2015
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Secret of Youth

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
Parapsoriasis Drug: natural gels Drug: Placebo Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Factorial 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 : January 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Active Comparator: patients
natural gels
Drug: natural gels
whole fruits and vegetables
Other Name: plant origin

Placebo Comparator: subjects
These patients will receive that placebo (vehicle) products.
Drug: Placebo



Primary Outcome Measures :
  1. Modified Psoriasis Assessment severity index [ Time Frame: up to 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Efraim Ben-Ari, Ph.D. +972-54-4773623 efraimbenari@gmail.com
Contact: Rami Maimon, MBA +972-3-6343444 rami@s-of-y.com

Locations
Israel
Chaim sheba Medical Center, Dept. of Dermatolgy. Tel-Hashomer, Israel Recruiting
Tel Hasomer, Ramat-almogi, Israel, 34793
Contact: EFRAIM BEN-ARI, Ph.D.    972-54-4773623    efraimbenari@gmail.com   
Contact: Felix Pavlotsky, MD    972-528305227    felix.pavlotsky@sheba.health.gov.il   
Sponsors and Collaborators
Secret of Youth
Investigators
Principal Investigator: Felix Pavlotzky, MD Chaim sheba Medical Center, Dept. of Dermatolgy. Tel-Hashomer, Israel

Responsible Party: Secret of Youth
ClinicalTrials.gov Identifier: NCT02330237     History of Changes
Other Study ID Numbers: NGCPP
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Psoriasis
Parapsoriasis
Skin Diseases, Papulosquamous
Skin Diseases