Psoriasis VulgarisPhase 1NCT02577185
An Exploratory Trial Investigating the Neurogenic Component in Psoriasis Vulgaris by Use of Botulinum Toxin A
A Phase 1 study testing Botulinum Toxin Type A and Sodium chloride 9 mg/ml in people with Psoriasis Vulgaris, run by LEO Pharma at 2 sites in Denmark.
Trial summary
The purpose of this study is to evaluate the anti-psoriatic effect of injected Botulinum toxin type A compared to that of injected vehicle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Botulinum Toxin Type A and Sodium chloride 9 mg/ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2015to Jul 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or above
- A diagnosis of psoriasis vulgaris with lesions located on arms and/or legs and/or trunk
- Chronic stable psoriasis vulgaris diagnosed more than 6 months prior to screening.
- Women must use a reliable contraceptive during the trial.
Who cannot join
- Pregnant or breast feeding women, or women planning to become pregnant.
- Skin infection at injection sites
- Use of biological therapies or small molecules (marketed or not marketed) with a possible effect on psoriasis vulgaris
- Use of systemic treatments with a potential effect on psoriasis vulgaris
- Exposure to phototherapy within 4 weeks for PUVA and 2 weeks for UVB prior to Randomisation
- Use of potent or very potent (WHO group III-IV) corticosteroids for topical treatment of psoriasis within a 4 week period prior to randomisation
Show all 9Show fewer
- Use of muscle relaxants
- History of dysphagia or aspiration
- Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Hud- og Kønssygdomme, Aarhus Universitetshospital
Aarhus, 8000
Hud- og allergiafdeling, Gentofte Hospital
Gentofte Municipality, 2900
About this study
Official title: An Exploratory Psoriasis Plaque Test Trial Investigating the Neurogenic Component in Psoriasis Vulgaris by Use of Botulinum Toxin A as Tool Compound
The purpose of this study is to evaluate the anti-psoriatic effect of injected Botulinum toxin type A compared to that of injected vehicle.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Botulinum Toxin Type A, Sodium chloride 9 mg/ml
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium chloride 9 mg/mlDrug
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin type A | Experimental | Experimental drug Receives: Drug: Botulinum Toxin Type A |
| sodium chloride 9 mg/ml | Placebo comparator | Vehicle drug Receives: Drug: Sodium chloride 9 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in Total Clinical Score (TCS) of clinical signs at 8 weeks after injection compared to baseline
Measured: 8 weeks
Secondary outcomes (20)
Absolute change in clinical score erythema at week 1 compared to baseline
Measured: 1 week
Absolute change in clinical score erythema at week 3 compared to baseline
Measured: 3 weeks
Absolute change in clinical score erythema at week 4 compared to baseline
Measured: 4 weeks
Absolute change in clinical score erythema at week 8 compared to baseline
Measured: 8 weeks
Absolute change in clinical score scaling at week 1 compared to baseline
Measured: 1 week
Absolute change in clinical score scaling at week 3 compared to baseline
Measured: 3 weeks
Absolute change in clinical score scaling at week 4 compared to baseline
Measured: 4 weeks
Absolute change in clinical score scaling at week 8 compared to baseline
Measured: 8 weeks
Absolute change in clinical score infiltration at week 1 compared to baseline
Measured: 1 week
Absolute change in clinical score infiltration at week 3 compared to baseline
Measured: 3 weeks
Absolute change in clinical score infiltration at week 4 compared to baseline
Measured: 4 weeks
Absolute change in clinical score infiltration at week 8 compared to baseline
Measured: 8 weeks
Absolute change in TCS at week 1 compared to baseline
Measured: 1 week
Absolute change in TCS at week 3 compared to baseline
Measured: 3 weeks
Absolute change in TCS at week 4 compared to baseline
Measured: 4 weeks
Incidence of treatment emergent adverse events
Measured: 10 weeks
Incidende of adverse events on the treated test sites
Measured: 10 weeks
Incidence of adverse events leading to withdrawal from trial
Measured: 8 weeks
Change in blood pressure from baseline to week 8
Measured: 8 weeks
Change in heart rate from baseline to week 8
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars Iversen, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577185
- Sponsor's protocol ID
- EXP-1187
- Status last verified
- May 2017
- First submitted
- 9 Oct 2015
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Psoriasis Plaque Test Trial Investigating the Neurogenic Component in Psoriasis Vulgaris by Use of Botulinum Toxin A as Tool Compound
- ClinicalTrials.gov ID
- NCT02577185
- Acronym / sponsor ID
- EXP-1187
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 Oct 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 purpose of this study is to evaluate the anti-psoriatic effect of injected Botulinum toxin type A compared to that of injected vehicle.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin type A | Experimental | Drug: Botulinum Toxin Type AExperimental drug |
| sodium chloride 9 mg/ml | Placebo comparator | Drug: Sodium chloride 9 mg/mlVehicle drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or above
- A diagnosis of psoriasis vulgaris with lesions located on arms and/or legs and/or trunk
- Chronic stable psoriasis vulgaris diagnosed more than 6 months prior to screening.
- Women must use a reliable contraceptive during the trial.
Key exclusion criteria (9 listed)
- Pregnant or breast feeding women, or women planning to become pregnant.
- Skin infection at injection sites
- Use of biological therapies or small molecules (marketed or not marketed) with a possible effect on psoriasis vulgaris
- Use of systemic treatments with a potential effect on psoriasis vulgaris
- Exposure to phototherapy within 4 weeks for PUVA and 2 weeks for UVB prior to Randomisation
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 |
|---|---|---|
| Botulinum Toxin Type A | Drug | botulinum toxin type A |
| Sodium chloride 9 mg/ml | Drug | sodium chloride 9 mg/ml |
Primary outcome
Absolute change in Total Clinical Score (TCS) of clinical signs at 8 weeks after injection compared to baseline
Time frame: 8 weeks
20 secondary outcomes
Absolute change in clinical score erythema at week 1 compared to baseline
Time frame: 1 week
Absolute change in clinical score erythema at week 3 compared to baseline
Time frame: 3 weeks
Absolute change in clinical score erythema at week 4 compared to baseline
Time frame: 4 weeks
Absolute change in clinical score erythema at week 8 compared to baseline
Time frame: 8 weeks
Absolute change in clinical score scaling at week 1 compared to baseline
Time frame: 1 week
Absolute change in clinical score scaling at week 3 compared to baseline
Time frame: 3 weeks
Absolute change in clinical score scaling at week 4 compared to baseline
Time frame: 4 weeks
Absolute change in clinical score scaling at week 8 compared to baseline
Time frame: 8 weeks
Absolute change in clinical score infiltration at week 1 compared to baseline
Time frame: 1 week
Absolute change in clinical score infiltration at week 3 compared to baseline
Time frame: 3 weeks
Absolute change in clinical score infiltration at week 4 compared to baseline
Time frame: 4 weeks
Absolute change in clinical score infiltration at week 8 compared to baseline
Time frame: 8 weeks
Absolute change in TCS at week 1 compared to baseline
Time frame: 1 week
Absolute change in TCS at week 3 compared to baseline
Time frame: 3 weeks
Absolute change in TCS at week 4 compared to baseline
Time frame: 4 weeks
Incidence of treatment emergent adverse events
Time frame: 10 weeks
Incidende of adverse events on the treated test sites
Time frame: 10 weeks
Incidence of adverse events leading to withdrawal from trial
Time frame: 8 weeks
Change in blood pressure from baseline to week 8
Time frame: 8 weeks
Change in heart rate from baseline to week 8
Time frame: 8 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 24 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Lars Iversen, MD principal investigator
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Botulinum Toxin Type A and Sodium chloride 9 mg/ml in people with Psoriasis Vulgaris, run by LEO Pharma at 2 sites in Denmark.
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 4 inclusion and 9 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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
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?
Absolute change in Total Clinical Score (TCS) of clinical signs at 8 weeks after injection compared to baseline (time frame: 8 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 24 Feb 2025.