Natural Gels for Treatment of Plaque Psoriasis

Secret of Youth

Status and phase: Completed; Phase 3; Phase 2

Conditions: Parapsoriasis

Treatments: Drug: Placebo; Drug: natural gels

Study type: Interventional

Funder types: Industry

Identifiers

NCT02330237

NGCPP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups, including a placebo group

patients

Active Comparator group

Description:

natural gels

Treatment:

Drug: natural gels

subjects

Placebo Comparator group

Description:

These patients will receive that placebo (vehicle) products.

Treatment:

Drug: Placebo