NCT02330237CompletedPhase 2
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Secret of Youth
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Modified Psoriasis Assessment severity index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
patients
Active Comparator
natural gels
Intervention: natural gels (Drug)
subjects
Placebo Comparator
These patients will receive that placebo (vehicle) products.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Modified Psoriasis Assessment severity index
Time Frame: up to 16 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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