ParapsoriasisPhase 2/3NCT02330237
Natural Gels for Treatment of Plaque Psoriasis
A Phase 2/3 study testing natural gels in people with Parapsoriasis, run by Secret of Youth at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parapsoriasis
- What is being tested?
- natural gels
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Sep 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Chaim Sheba Med. center. Dept. Of Dermatology
Reamat- Gan, Ramat-almogi, 34793
About this study
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
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.
- Conditions
- Parapsoriasis
- Being tested
- natural gels, Placebo
- Medical subject headings
- Parapsoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natural gelsDrug
Also called plant origin
whole fruits and vegetables
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| patients | Active comparator | natural gels Receives: Drug: natural gels |
| subjects | Placebo comparator | These patients will receive that placebo (vehicle) products. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Psoriasis Assessment severity index
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParapsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Secret of Youth
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felix Pavlotzky, MD, Principal investigator, Chaim sheba Medical Center, Dept. of Dermatolgy. Tel-Hashomer, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330237
- Sponsor's protocol ID
- NGCPP
- Status last verified
- Jul 2018
- First submitted
- 30 Dec 2014
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02330237
- Acronym / sponsor ID
- NGCPP
- Conditions
- Parapsoriasis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Secret of YouthIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 1 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | Active comparator | Drug: natural gelsnatural gels |
| subjects | Placebo comparator | Drug: PlaceboThese patients will receive that placebo (vehicle) products. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| natural gelsAlso: plant originwhole fruits and vegetables | Drug | patients |
| Placebo | Drug | subjects |
Primary outcome
Modified Psoriasis Assessment severity index
Time frame: up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Pavlotzky, MD principal investigator
Chaim sheba Medical Center, Dept. of Dermatolgy. Tel-Hashomer, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing natural gels in people with Parapsoriasis, run by Secret of Youth at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Psoriasis Assessment severity index (time frame: up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.