Back to resultsNatural Gels for Treatment of Plaque Psoriasis
Primary Purpose
Parapsoriasis
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
natural gels
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parapsoriasis
Eligibility Criteria
Inclusion Criteria:
- Subjects with stable (for at least 6 months), mild to moderate (less than 10% of the skin surface area) plaque psoriasis.
- Male and female ≥ 18 years old.
- Subject is capable of giving a written informed consent.
Exclusion Criteria:
- Subjects treated by topical or photo or systemic anti psoriatic therapy during 4 weeks prior to the study.
- Subjects treated with Biological products for psoriasis for the last 3 months prior to starting the present study.
- Subjects with any other type of psoriasis but vulgaris (plaque ).
- Use of investigational agents < 30 days prior to the study.
- Low compliance.
- Subjects who are mentally or physically unable to comply with all aspects of the study.
- Pregnant women.
- Known allergic reaction to fragrance or any ingredient of the test products.
- Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis.
- A medical condition that may put the patient at a general risk and therefore would prevent participation in the clinical trial.
Sites / Locations
- Chaim Sheba Med. center. Dept. Of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
patients
subjects
Arm Description
natural gels
These patients will receive that placebo (vehicle) products.
Outcomes
Primary Outcome Measures
Modified Psoriasis Assessment severity index
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02330237
Brief Title
Natural Gels for Treatment of Plaque Psoriasis
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 Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Secret of Youth
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parapsoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients
Arm Type
Active Comparator
Arm Description
natural gels
Arm Title
subjects
Arm Type
Placebo Comparator
Arm Description
These patients will receive that placebo (vehicle) products.
Intervention Type
Drug
Intervention Name(s)
natural gels
Other Intervention Name(s)
plant origin
Intervention Description
whole fruits and vegetables
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Modified Psoriasis Assessment severity index
Time Frame
up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with stable (for at least 6 months), mild to moderate (less than 10% of the skin surface area) plaque psoriasis.
Male and female ≥ 18 years old.
Subject is capable of giving a written informed consent.
Exclusion Criteria:
Subjects treated by topical or photo or systemic anti psoriatic therapy during 4 weeks prior to the study.
Subjects treated with Biological products for psoriasis for the last 3 months prior to starting the present study.
Subjects with any other type of psoriasis but vulgaris (plaque ).
Use of investigational agents < 30 days prior to the study.
Low compliance.
Subjects who are mentally or physically unable to comply with all aspects of the study.
Pregnant women.
Known allergic reaction to fragrance or any ingredient of the test products.
Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis.
A medical condition that may put the patient at a general risk and therefore would prevent participation in the clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix Pavlotzky, MD
Organizational Affiliation
Chaim sheba Medical Center, Dept. of Dermatolgy. Tel-Hashomer, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaim Sheba Med. center. Dept. Of Dermatology
City
Reamat- Gan
State/Province
Ramat-almogi
ZIP/Postal Code
34793
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Natural Gels for Treatment of Plaque Psoriasis
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