Natural Gels for Treatment of Plaque Psoriasis

NCT02330237 | Completed Phase 2 DMC

• 1 other identifier: NGCPP
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Parapsoriasis

Outcome Measures

Primary Outcomes (1)

• Modified Psoriasis Assessment severity index

  up to 16 weeks

Study Arms (2)

patients

ACTIVE COMPARATOR

natural gels

Drug: natural gels

subjects

PLACEBO COMPARATOR

These patients will receive that placebo (vehicle) products.

Drug: Placebo

Interventions

natural gels DRUG

whole fruits and vegetables

Also known as: plant origin

patients

Placebo DRUG

subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Secret of Youth: lead

Study Sites (1)

Chaim Sheba Med. center. Dept. Of Dermatology

Reamat- Gan, Ramat-almogi, 34793, Israel

Location

MeSH Terms

Conditions

Parapsoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Felix Pavlotzky, MD

  Chaim sheba Medical Center, Dept. of Dermatolgy. Tel-Hashomer, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2014
• First Posted: January 1, 2015
• Study Start: January 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: September 1, 2017
• Last Updated: July 23, 2018

Record last verified: 2018-07

Locations

IL (1)