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CompletedNCT02330237Updated Jul 23, 2018

Natural Gels for Treatment of Plaque Psoriasis

A Phase 2/3 interventional study of natural gels and Placebo in Parapsoriasis, sponsored by Secret of Youth. Completed at 1 site in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-23.

Sponsored by Secret of Youth · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Parapsoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 45 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

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Lead sponsor

This is the only study on the registry with Secret of Youth as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    patients

    natural gels

    Drug: natural gels

  • Placebo comparator
    subjects

    These patients will receive that placebo (vehicle) products.

    Drug: Placebo

Interventions

  • Drugnatural gels

    whole fruits and vegetables

    Also known as: plant origin

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Modified Psoriasis Assessment severity index

    Time frame: up to 16 weeks

07

Study locations

1 site
  • Chaim Sheba Med. center. Dept. Of Dermatology
    Reamat- Gan, Ramat-almogi 34793, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02330237
Lead sponsor
Secret of Youth
Responsible party
Sponsor
First posted
Jan 1, 2015
Start date
Jan 2015
Primary completion
Nov 2016
Completion
Sep 2017
Last update
Jul 23, 2018

Study contacts

Felix Pavlotzky, MD
principal investigator · Chaim sheba Medical Center, Dept. of Dermatolgy. Tel-Hashomer, Israel

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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