Plaque PsoriasisNCT02881346
Efficacy and Tolerability of Enstilar® in Daily Practice
An observational study of Plaque Psoriasis, run by LEO Pharma at 1 site in Germany.
Trial summary
This study aims to assess how the Enstilar® aerosol foam performs in daily real-life practice with regards to effectiveness and convenience of application to psoriasis plaques on body and extremities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Enstilar®
- How many people
- 410 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to Mar 2017
- Phase
- Observational
- 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
Study population: Adult patients with psoriasis vulgaris plaques on trunk and/or extremities of at least mild severity for whom topical treatment with Enstilar® is planned
Who may be able to join
- ≥ 18 years of age
- Psoriasis vulgaris
- Lesions on trunk and/or extremities of at least mild severity
- Treatment with Enstilar® planned
- Signed informed consent to participate
Who cannot join
- Enrolled in any interventional clinical trial
- Ongoing or recent treatment with any systemic psoriasis
- Ongoing or recent treatment with UV-therapy
- Ongoing or previous treatment with Enstilar®
- Psoriasis of scalp only
- Other forms of psoriasis, e.g. erythrodermic or pustular psoriasis
Show all 9Show fewer
- More than 30% of surface area affected by psoriasis
- Any contraindications or known allergies to Enstilar® or its ingredients
- Incapacitated patients under institutionalized care
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein
Kiel
About this study
Official title: Prospective, Observational, Non-interventional, Multicenter Study on the Efficacy and Tolerability of Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients With Plaque Psoriasis Under Daily Practice Conditions
This study aims to assess how the Enstilar® aerosol foam performs in daily real-life practice with regards to effectiveness and convenience of application to psoriasis plaques on body and extremities. In addition the profiles of patients prescribed Enstilar® will be described, and preceeding, concomitant and follow-up management will be mapped. The study will be conducted in about 100 dermatology clinics all over Germany,
- Conditions
- Plaque Psoriasis
- Being tested
- Enstilar®
- Keywords
- Psoriasis vulgaris, Plaque, Topical, Calcipotriol, Foam, Spray
- Medical subject headings
- Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enstilar®Drug
Also called calcipotriol/betamethasone dipropionate cutaneous foam
Once daily application of cutaneous foam to plaques on body and/or extremities
| Study group | Role | What they receive |
|---|---|---|
| Enstilar® | Patients with psoriasis vulgaris plaques on body and/or extremities will apply Enstilar® (calcipotriol /betamethasone dipropionate (50 micrograms/g + 0.5 mg/g) cutaneous foam) once daily for up to 4 weeks, according to the approved labelling of Enstilar® in Germany. Receives: Drug: Enstilar® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Global Assessment
5-point Likert scale
Measured: Week 4
Percentage of total body surface area affected
Percentage
Measured: 4 weeks
Absence of related adverse events (ADR)
Proportion of patients with no ADRs
Measured: 4 weeks
Secondary outcomes (13)
Patient Global Assessment
5-point Likert scale
Measured: 4 weeks
PASI 50
Psoriasis Area and Severity Index
Measured: 4 weeks
PASI 75
Psoriasis Area and Severity Index
Measured: 4 weeks
Patient reported itching
10-point scale
Measured: 4 weeks
Patient reported sleep loss
10-point scale
Measured: 4 weeks
Patient reported erythema
10-point scale
Measured: 4 weeks
Patient reported scaling
10-point scale
Measured: 4 weeks
Patient reported dry skin
10-point scale
Measured: 4 weeks
Patient reported overall treatment satisfaction
4-point Likert scale
Measured: 4 weeks
Patient reported satisfaction with effectiveness
4-point Likert scale
Measured: 4 weeks
Patient reported satisfaction with tolerability
4-point Likert scale
Measured: 4 weeks
Patient reported satisfaction with convenience
4-point Likert scale
Measured: 4 weeks
Dermatology Life Quality Index
Standard Quality of Life Questionnaire (DLQI)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sascha Gerdes, Dr.med., Principal investigator, Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein, Campus Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881346
- Sponsor's protocol ID
- NIS-ENSTILAR-1295
- Status last verified
- Dec 2019
- First submitted
- 23 Aug 2016
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Langley RG, Feldman SR, Nyirady J, van de Kerkhof P, Papavassilis C. The 5-point Investigator's Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2015 Feb;26(1):23-31. doi: 10.3109/09546634.2013.865009. Epub 2013 Dec 20.
PubMed 24354461Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
PubMed 8033378Gerdes S, Krakor M, Anger T, Hutt HJ, Korber A. Prospective, Observational, Non-Interventional, Multicentre Study on the Efficacy and Tolerability of a New Calcipotriol/Betamethasone Aerosol Foam (Enstilar(R)) in Patients with Plaque Psoriasis under Daily Practice Conditions. Dermatology. 2017;233(6):425-434. doi: 10.1159/000486700. Epub 2018 Mar 2.
PubMed 29502110
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational, Non-interventional, Multicenter Study on the Efficacy and Tolerability of Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients With Plaque Psoriasis Under Daily Practice Conditions
- ClinicalTrials.gov ID
- NCT02881346
- Acronym / sponsor ID
- NIS-ENSTILAR-1295
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis vulgaris, Plaque, Topical, Calcipotriol, Foam, Spray
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 29 Aug 2016 (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.
This study aims to assess how the Enstilar® aerosol foam performs in daily real-life practice with regards to effectiveness and convenience of application to psoriasis plaques on body and extremities. In addition the profiles of patients prescribed Enstilar® will be described, and preceeding, concomitant and follow-up management will be mapped. The study will be conducted in about 100 dermatology clinics all over Germany,
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enstilar® | – | Drug: Enstilar®Patients with psoriasis vulgaris plaques on body and/or extremities will apply Enstilar® (calcipotriol /betamethasone dipropionate (50 micrograms/g + 0.5 mg/g) cutaneous foam) once daily for up to 4 weeks, according to the approved labelling of Enstilar® in Germany. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with psoriasis vulgaris plaques on trunk and/or extremities of at least mild severity for whom topical treatment with Enstilar® is planned
Key inclusion criteria (5 listed)
- ≥ 18 years of age
- Psoriasis vulgaris
- Lesions on trunk and/or extremities of at least mild severity
- Treatment with Enstilar® planned
- Signed informed consent to participate
Key exclusion criteria (9 listed)
- Enrolled in any interventional clinical trial
- Ongoing or recent treatment with any systemic psoriasis
- Ongoing or recent treatment with UV-therapy
- Ongoing or previous treatment with Enstilar®
- Psoriasis of scalp only
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 |
|---|---|---|
| Enstilar®Also: calcipotriol/betamethasone dipropionate cutaneous foamOnce daily application of cutaneous foam to plaques on body and/or extremities | Drug | Enstilar® |
Primary outcome
Investigator Global Assessment
Time frame: Week 4
5-point Likert scale
Percentage of total body surface area affected
Time frame: 4 weeks
Percentage
Absence of related adverse events (ADR)
Time frame: 4 weeks
Proportion of patients with no ADRs
13 secondary outcomes
Patient Global Assessment
Time frame: 4 weeks
PASI 50
Time frame: 4 weeks
PASI 75
Time frame: 4 weeks
Patient reported itching
Time frame: 4 weeks
Patient reported sleep loss
Time frame: 4 weeks
Patient reported erythema
Time frame: 4 weeks
Patient reported scaling
Time frame: 4 weeks
Patient reported dry skin
Time frame: 4 weeks
Patient reported overall treatment satisfaction
Time frame: 4 weeks
Patient reported satisfaction with effectiveness
Time frame: 4 weeks
Patient reported satisfaction with tolerability
Time frame: 4 weeks
Patient reported satisfaction with convenience
Time frame: 4 weeks
Dermatology Life Quality Index
Time frame: 4 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 13 Dec 2019.
- Background: PubMed 24354461Langley RG, Feldman SR, Nyirady J, van de Kerkhof P, Papavassilis C. The 5-point Investigator's Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2015 Feb;26(1):23-31. doi: 10.3109/09546634.2013.865009. Epub 2013 Dec 20.
- Background: PubMed 8033378Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
- Results publication: PubMed 29502110Gerdes S, Krakor M, Anger T, Hutt HJ, Korber A. Prospective, Observational, Non-Interventional, Multicentre Study on the Efficacy and Tolerability of a New Calcipotriol/Betamethasone Aerosol Foam (Enstilar(R)) in Patients with Plaque Psoriasis under Daily Practice Conditions. Dermatology. 2017;233(6):425-434. doi: 10.1159/000486700. Epub 2018 Mar 2.
- 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.
Sascha Gerdes, Dr.med. principal investigator
Clinic for Dermatology, Venereology and Allergy, University Clinic Schleswig-Holstein, Campus Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis, run by LEO Pharma at 1 site in Germany.
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 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 13 Dec 2019. 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 Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Investigator Global Assessment (time frame: Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02881346, which also lists 3 linked publications.
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 13 Dec 2019.