Plaque PsoriasisASAP PSONCT02856542
Real-life Evaluation of the Daivobet® Gel Applicator
An observational study of Plaque Psoriasis, run by LEO Pharma at 1 site in France.
Trial summary
This study aims to describe the patient population being treated and evaluate their treatment adherence and treatment outcomes during treatment of scalp psoriasis with Daivobet® gel Applicator for 4 weeks. 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?
- calcipotriol/betamethasone dipropionate gel in Applicator
- How many people
- 1,560 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2016to Jun 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 affecting the scalp who are prescribed scalp treatment with Daivobet® gel Applicator. Representativeness is ensured through random sampling of investigators to be invited to participate from a country wide list of dermatologists and general practitioners, with adjustment for regional distribution. Investigators include their first three patients meeting the study criteria.
Who may be able to join
- Age ≥ 18 years
- Dermatologist or general practitioner has decided to initiate treatment with Daivobet® gel Applicator
Who cannot join
- Indication not within the approved labelling in France
- Contraindication for treatment with calcipotriol or betamethasone dipropionate
- Informed consent to participate in the study has not been obtained
Trial locations and contacts
1 site in 1 country.
France1 site
Cabinet de Dermatologie, Dr. Mathilde Kemula
Charenton-le-Pont, 94220
About this study
Official title: Real-life Evaluation of an Applicator, as a New Mode of Administration of Daivobet® Gel, on Adherence to Treatment and SAtisfaction of Patients With PSOriasis
This study aims to describe the patient population being treated and evaluate their treatment adherence and treatment outcomes during treatment of scalp psoriasis with Daivobet® gel Applicator for 4 weeks.
- Conditions
- Plaque Psoriasis
- Being tested
- calcipotriol/betamethasone dipropionate gel in Applicator
- Keywords
- Psoriasis vulgaris, scalp, topical, applicator, device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcipotriol/betamethasone dipropionate gel in ApplicatorDrug
Also called Daivobet® gel Applicator
Topical treatment of scalp using applicator device. The study as such is non-interventional as the intervention has been decided prior to and independently from the inclusion of the patient in the cohort to be observed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Morisky Medication Adherence Scale-8
Degree of adherence to prescribed treatment
Measured: 2 weeks
Morisky Medication Adherence Scale-8
Degree of adherence to prescribed treatment
Measured: 4 weeks
Secondary outcomes (5)
Patient opinion on Applicator usability
5-point Likert scale
Measured: 4 weeks
Patient overall satisfaction
4 point Likert scale
Measured: 4 weeks
Patient Global Impression of Improvement
7 point Likert scale
Measured: 2 weeks
Patient Global Impression of Improvement
7 point Likert scale
Measured: 4 weeks
Investigator's opinion on the properties of the Applicator
5 point rating scale
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start23 May 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 1,560 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mathilde Kemula, MD, Principal investigator, Cabinet de Dermatologie, Dr. Mathilde KemulaFrederic Bonnier, MD, Principal investigator, General Practice, 356 Rue de Charles de Gaulle, 91400 OrsayNathalie Quiles, MD, Principal investigator, Hôpital Saint Joseph, 26 Boulevard de Louvain, Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856542
- Sponsor's protocol ID
- NIS-DAIVOBETGEL-1284
- Acronym
- ASAP PSO
- Status last verified
- Oct 2017
- First submitted
- 11 Jul 2016
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
PubMed 3945130
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Evaluation of an Applicator, as a New Mode of Administration of Daivobet® Gel, on Adherence to Treatment and SAtisfaction of Patients With PSOriasis
- ClinicalTrials.gov ID
- NCT02856542
- Acronym / sponsor ID
- ASAP PSO / NIS-DAIVOBETGEL-1284
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis vulgaris, scalp, topical, applicator, device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,560 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 23 May 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 5 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 describe the patient population being treated and evaluate their treatment adherence and treatment outcomes during treatment of scalp psoriasis with Daivobet® gel Applicator for 4 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 affecting the scalp who are prescribed scalp treatment with Daivobet® gel Applicator. Representativeness is ensured through random sampling of investigators to be invited to participate from a country wide list of dermatologists and general practitioners, with adjustment for regional distribution. Investigators include their first three patients meeting the study criteria.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Dermatologist or general practitioner has decided to initiate treatment with Daivobet® gel Applicator
Key exclusion criteria (3 listed)
- Indication not within the approved labelling in France
- Contraindication for treatment with calcipotriol or betamethasone dipropionate
- Informed consent to participate in the study has not been obtained
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 |
|---|---|---|
| calcipotriol/betamethasone dipropionate gel in ApplicatorAlso: Daivobet® gel ApplicatorTopical treatment of scalp using applicator device. The study as such is non-interventional as the intervention has been decided prior to and independently from the inclusion of the patient in the cohort to be observed. | Drug | – |
Primary outcome
Morisky Medication Adherence Scale-8
Time frame: 2 weeks
Degree of adherence to prescribed treatment
Morisky Medication Adherence Scale-8
Time frame: 4 weeks
Degree of adherence to prescribed treatment
5 secondary outcomes
Patient opinion on Applicator usability
Time frame: 4 weeks
Patient overall satisfaction
Time frame: 4 weeks
Patient Global Impression of Improvement
Time frame: 2 weeks
Patient Global Impression of Improvement
Time frame: 4 weeks
Investigator's opinion on the properties of the Applicator
Time frame: Baseline
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 19 Oct 2017.
- Background: PubMed 3945130Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
- 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.
Mathilde Kemula, MD principal investigator
Cabinet de Dermatologie, Dr. Mathilde Kemula
Frederic Bonnier, MD principal investigator
General Practice, 356 Rue de Charles de Gaulle, 91400 Orsay
Nathalie Quiles, MD principal investigator
Hôpital Saint Joseph, 26 Boulevard de Louvain, Marseille
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 France.
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 2 inclusion and 3 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 19 Oct 2017. 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 France. 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?
Morisky Medication Adherence Scale-8 (time frame: 2 weeks). The study lists 2 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 NCT02856542, which also lists 1 linked publication.
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 19 Oct 2017.