Plaque PsoriasisPhase 1EGFRNCT01566578
A Physiological Study on Downregulation of EGF-receptors in the Skin by Topical Exposition With EGF
A Phase 1 study testing Human recombinant epidermal growth factor in people with Plaque Psoriasis, run by Ennar Pharmaceuticals AF at 1 site in Switzerland.
Trial summary
Investigation of EGF-Receptor Downregulation by topical EGF (dermal cream) exposition. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Human recombinant epidermal growth factor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2012to Nov 2012
- Phase
- Phase 1
- 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 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent
- Mild to moderate psoriasis (all types) with active plaques on both body sides accessible for biopsy and self product application
- EGFR immunohistochemistry score > 5
- Male
- Age 18-60 years
Who cannot join
- Systemic psoriasis treatment 3 months prior and during the study
- Local psoriasis treatment on the investigational sites in the last 30 days or during the study
- Known hypersensitivity or allergy to the EGF containing product (Newskin) and/or to Vaseline/10% salicylic acid and/or to local anaesthetics of the amid type
- Known or suspected non-compliance to study protocol Coagulopathy or treatment with anticoagulants
- History of malignant disease Other clinically relevant concomitant disease state Participation in another investigational drug study in the last 30 days
Trial locations and contacts
1 site in 1 country.
Michael Weisskopf, MD contact
Rudi Neirinckx, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Dermatology Clinic
Zurich, Canton of Zurich, 8091
Michael Weisskopf, MD, michael.weisskopf@usz.ch
Michael Weisskopf, MD
About this study
Investigation of EGF-Receptor Downregulation by topical EGF (dermal cream) exposition.
- Conditions
- Plaque Psoriasis
- Being tested
- Human recombinant epidermal growth factor, Placebo cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human recombinant epidermal growth factorDrug
topical
Placebo creamOther
Dermal cream without EGF
| Study group | Role | What they receive |
|---|---|---|
| EGF Cream | Experimental | Not described Receives: Drug: Human recombinant epidermal growth factor |
| Placebo cream | Placebo comparator | Not described Receives: Other: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in EGFR density in epidermis of psoriasis lesion
Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment, which is on day 66.
EGFR immunohistochemistry will be performed with a murine antibody directed against the extracellular domain of human EGFR. A pathologist blinded to the patient's characteristics and treatment modalities assesses the immunohistochemistry staining in three epidermal layers. A score ranging form 0 (no staining) to 3 (intense staining) is applied, resulting in a total score ranging form 0 (3x0) to 9 (3x3).
Measured: Day 66
Secondary outcomes (5)
Change to baseline in target lesion severity score (PASI)
A blinded dermatologist assesses the treated psoriasis plaque clinically using the lesion assessment part of the PASI score, assessing 3 qualities (thicknes, redness and scaling) of the lesion. Score ranges from 0 (absent) to 4 (very severe), resulting in a total score of 0 to 12 (3 x 4)
Measured: Day 80
Change to baseline in histological feature: thickness of the epidermis
Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment on day 66.
A pathologist blinded to the patient's characteristics and treatment modalities assesses the following histological features: thicknes of the epidermis, acanthosis and epidermal/dermal lymphocytic infiltrates. Each characteristic is scored as follows: 0 = normal, + = mild, and ++ = marked.
Measured: Day 66
Number of participants with adverse events
At every visit the patients are asked about the occurence of adverse events. The last visit is on day 80. All adverse events will be recorded in the crf.
Measured: Day 80
Change to baseline in the histological feature: acanthosis
Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment on day 66.
A pathologist blinded to the patient's characteristics and treatment modalities assesses the following histological features: thicknes of the epidermis, acanthosis and epidermal/dermal lymphocytic infiltrates. Each characteristic is scored as follows: 0 = normal, + = mild, and ++ = marked.
Measured: Day 66
Change to baseline in histological feature: epidermal/dermal lymphocytic infiltrates
Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment on day 66.
A pathologist blinded to the patient's characteristics and treatment modalities assesses the following histological features: thicknes of the epidermis, acanthosis and epidermal/dermal lymphocytic infiltrates. Each characteristic is scored as follows: 0 = normal, + = mild, and ++ = marked.
Measured: Day 66
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ennar Pharmaceuticals AF
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Thomas Kündig, MD, Principal investigator, University Hospital Zurich, Dermatology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566578
- Sponsor's protocol ID
- EGFR-Study
- Acronym
- EGFR
- Status last verified
- Aug 2012
- First submitted
- 21 Mar 2012
- Last updated
- 3 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physiological Study on Downregulation of EGF-receptors in the Skin by Topical Exposition With EGF
- ClinicalTrials.gov ID
- NCT01566578
- Acronym / sponsor ID
- EGFR / EGFR-Study
- Conditions
- Plaque Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ennar Pharmaceuticals AFIndustry (pharma, biotech, devices)
- Collaborators
- University of Zurich
- Study start
- Apr 2012
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 29 Mar 2012 (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.
Investigation of EGF-Receptor Downregulation by topical EGF (dermal cream) exposition.
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 |
|---|---|---|
| EGF Cream | Experimental | Drug: Human recombinant epidermal growth factor |
| Placebo cream | Placebo comparator | Other: Placebo cream |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Informed consent
- Mild to moderate psoriasis (all types) with active plaques on both body sides accessible for biopsy and self product application
- EGFR immunohistochemistry score > 5
- Male
- Age 18-60 years
Key exclusion criteria (5 listed)
- Systemic psoriasis treatment 3 months prior and during the study
- Local psoriasis treatment on the investigational sites in the last 30 days or during the study
- Known hypersensitivity or allergy to the EGF containing product (Newskin) and/or to Vaseline/10% salicylic acid and/or to local anaesthetics of the amid type
- Known or suspected non-compliance to study protocol Coagulopathy or treatment with anticoagulants
- History of malignant disease Other clinically relevant concomitant disease state Participation in another investigational drug study in the last 30 days
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 |
|---|---|---|
| Human recombinant epidermal growth factortopical | Drug | EGF Cream |
| Placebo creamDermal cream without EGF | Other | Placebo cream |
Primary outcome
Change from baseline in EGFR density in epidermis of psoriasis lesion
Time frame: Day 66
Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment, which is on day 66. EGFR immunohistochemistry will be performed with a murine antibody directed against the extracellular domain of human EGFR. A pathologist blinded to the patient's characteristics and treatment modalities assesses the immunohistochemistry staining in three epidermal layers. A score ranging form 0 (no staining) to 3 (intense staining) is applied, resulting in a total score ranging form 0 (3x0) to 9 (3x3).
5 secondary outcomes
Change to baseline in target lesion severity score (PASI)
Time frame: Day 80
Change to baseline in histological feature: thickness of the epidermis
Time frame: Day 66
Number of participants with adverse events
Time frame: Day 80
Change to baseline in the histological feature: acanthosis
Time frame: Day 66
Change to baseline in histological feature: epidermal/dermal lymphocytic infiltrates
Time frame: Day 66
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2012.
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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.
Michael Weisskopf, MD contact
Rudi Neirinckx, MD contact
Thomas Kündig, MD principal investigator
University Hospital Zurich, Dermatology Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Human recombinant epidermal growth factor in people with Plaque Psoriasis, run by Ennar Pharmaceuticals AF at 1 site in Switzerland.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Aug 2012. 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 Switzerland. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Weisskopf, MD (michael.weisskopf@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in EGFR density in epidermis of psoriasis lesion (time frame: Day 66). 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 3 Aug 2012.