Natural Gels for Treatment of Plaque Psoriasis

Parapsoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330237
• Other study ID #: NGCPP
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2015
• Est. completion date: September 2017

Study information

• Verified date: July 2018
• Source: Secret of Youth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parapsoriasis
• Psoriasis

Intervention

Drug:
• natural gels
whole fruits and vegetables
• Placebo

Locations

Country	Name	City	State
Israel	Chaim Sheba Med. center. Dept. Of Dermatology	Reamat- Gan	Ramat-almogi

Sponsors (1)

Lead Sponsor	Collaborator
Secret of Youth

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Psoriasis Assessment severity index		up to 16 weeks