Natural Gels for Treatment of Plaque Psoriasis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parapsoriasis

Intervention / Treatment
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* Drug: natural gels
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patients<br>natural gels | Drug: natural gels<br>* whole fruits and vegetables<br>* Other names: plant origin;|
| Placebo Comparator: subjects<br>These patients will receive that placebo (vehicle) products. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Psoriasis Assessment severity index |  | up to 16 weeks |