Mild to Moderate PsoriasisPhase 4PSO-TOPNCT01587755
Optimising Outpatient Care in Mild to Moderate Psoriasis (PSO-TOP)
A Phase 4 study testing TTOP and non-TTOP in people with Mild to Moderate Psoriasis, run by Kristian Reich, MD at 93 sites in 8 countries.
Trial summary
A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board to overcome non-adherence problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild to Moderate Psoriasis
- What is being tested?
- TTOP and non-TTOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,852 participants
- Where
- 93 sitesin 8 countries
- Study dates
- Mar 2012to Jun 2014
- Phase
- Phase 4
- 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
- Male and female patients aged at least 18 years
- Mild to moderate active plaque psoriasis with PGA ≥ 2 on the 7-point scale by Langley and Ellis and a Body Surface Area (BSA) of ≤ 10%
- Topical psoriasis treatment with coal or tar preparations, tazarotene, steroids, or vitamin D analogues, or combinations of steroids and vitamin D analogues (except gel combination products containing 50 micrograms calcipotriol/0.5mg betamethasone/g) or dithranol and its combination preparations over the last 8 weeks prior to Visit 1 (week 0)
- Written informed consent to participate in the study has been given prior to any study related procedures
Who cannot join
- Severe renal insufficiency
- Severe hepatic disorders
- Known hyper calcaemia
- Erythrodermic, exfoliative, pustular or guttate psoriasis
- Facial or genital psoriasis
- Fulfilment of at least one contraindication according to the Summary of Product Characteristics of Daivobet®/Dovobet® Gel
Show all 18Show fewer
- Pregnant and/or breast-feeding women
- Hypersensitivity to the active substances or to any of the excipients
- Suspected non-compliance with the clinical study procedures
- Current participation in another clinical study
- Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1 (week 0):
- etanercept - within 4 weeks prior to Visit 1 (week 0)
- adalimumab, alefacept, infliximab - within 2 months prior to Visit 1 (week 0)
- ustekinumab - within 4 months prior to Visit 1 (week 0)
- experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1 (week 0)
- Phototherapy within the following time periods prior to Visit 1 (week 0):
- PUVA - within 4 weeks prior to Visit 1 (week 0)
- UV-B - within 2 weeks prior to Visit 1 (week 0)
Trial locations and contacts
93 sites in 8 countries.
93 sites in 8 countries
Germany21 sites
Study site
Bad Bentheim
Study site
Berlin
Study site
Biberach
Study site
Blaubeuren Abbey
Study site
Bochum
Study site
Buchholz
Study site
Cologne
Study site
Dessau
Study site
Frankfurt
Study site
Friedrichshafen
Study site
Gilching
Study site
Hamburg
Study site
Hanover
Study site
Kiel
Study site
Mahlow
Study site
Osnabrück
Study site
Pinneberg
Study site
Selters
Study site
Weißenfels
Study site
Wolfenbüttel
Study site
Wuppertal
United Kingdom20 sites
Study site
Bexhill-on-Sea
Study site
Bradford
Study site
Burbage
Study site
Canterbury
Study site
Cheshire
Study site
Chesterfield
Study site
Coventry
Study site
Darwen
Study site
East Sussex
Study site
London
Study site
Manchester
Study site
Merseyside
Study site
Middlesex
Study site
Nantwich
Study site
Nuneaton
Study site
Oldham
Study site
Royal Leamington Spa
Study site
Royal Tunbridge Wells
Study site
Warwickshire
Study site
West Sussex
France14 sites
Study site
Angers
Study site
Auxerre
Study site
Brest
Study site
Lille
Study site
Limeil-Brévannes
Study site
Marseille
Study site
Martigues
Study site
Paris
Study site
Poitiers
Study site
Saint-Germain-en-Laye
Study site
Saint-Mandé
Study site
Saint-Priest-en-Jarez
Study site
Tours
Study site
Vienne
Italy14 sites
Study site
Brescia
Study site
Catania
Study site
Genova
Study site
L’Aquila
Study site
Lucca
Study site
Messina
Study site
Padova
Study site
Palermo
Study site
Parma
Study site
Pavia
Study site
Perugia
Study site
Rome
Study site
Trapani
Study site
Verona
Spain9 sites
Study site
Alicante
Study site
Barcelona
Study site
Fuenlabrada (Madrid)
Study site
Getafe (Madrid)
Study site
Madrid
Study site
Palma de Mallorca
Study site
Tarragona
Study site
Valencia
Study site
Zaragoza
Sweden6 sites
Study site
Eskilstuna
Study site
Gothenburg
Study site
Kristianstad
Study site
Linköping
Study site
Örebrö
Study site
Uppsala
Netherlands5 sites
Study site
Amsterdam
Study site
Geldrop
Study site
Maastricht
Study site
Nijmegen
Study site
Rotterdam
Denmark4 sites
Study site
Herning
Study site
Hobro
Study site
Roskilde
Study site
Vejle
About this study
Official title: Optimising Outpatient Care in Mild to Moderate Psoriasis by a Newly Developed 'Topical Treatment Optimising Programme' - an International Study Using Daivobet®/Dovobet® Gel
A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board to overcome non-adherence problems.
Read the detailed description
A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board. This tool is created to address patients' non-adherence in topical therapy and the resulting underperformance of such treatments in controlling psoriatic disease. The study addresses the effect of the relationship between the patient and the health care professional, one of the important factors that can affect treatment adherence and therapeutic efficacy. The TTOP will be compared to standardised regular care (called 'non-TTOP'). It is intended to clinically show the importance of an optimised contact between the patient and health care professional.
- Conditions
- Mild to Moderate Psoriasis
- Being tested
- TTOP, non-TTOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTOPOther
Patient is taken care of in an intensified, optimised manner
non-TTOPOther
Standard medical care
| Study group | Role | What they receive |
|---|---|---|
| Topical Treatment Optimizing Program | Other | Optimized care Receives: Other: TTOP |
| non-Topical Treatment Optimizing Program | Other | Standard care Receives: Other: non-TTOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Global Assessment (PGA)
PGA (Physician Global Assessment) will be assessed at all study visits. For week 8, the rate of patients with a PGA (as defined by Langley and Ellis 2004) of 0 or 1 will be calculated. This is the primary study parameter.
Measured: Up to 64 weeks; primary outcome assessed at week 8 after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,852 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristian Reich, MD
- Collaborators
- LEO Pharma
- Responsible party
- Sponsor-investigator, Kristian Reich, MD, Reich, Kristian, M.D.
- Investigators
- Kristian Reich, MD Prof., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587755
- Sponsor's protocol ID
- 055-006
- Acronym
- PSO-TOP
- Status last verified
- Mar 2015
- First submitted
- 25 Apr 2012
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Reich K, Zschocke I, Bachelez H, de Jong EM, Gisondi P, Puig L, Warren RB, Mrowietz U; TTOP study group. Efficacy of a fixed combination of calcipotriol/betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicenter, randomized, controlled, prospective study. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1156-63. doi: 10.1111/jdv.12774. Epub 2014 Oct 26.
PubMed 25346093Reich K, Mrowietz U, Karakasili E, Zschocke I. Development of an adherence-enhancing intervention in topical treatment termed the topical treatment optimization program (TTOP). Arch Dermatol Res. 2014 Sep;306(7):667-76. doi: 10.1007/s00403-014-1475-5. Epub 2014 Jun 4.
PubMed 24895177Zschocke I, Mrowietz U, Lotzin A, Karakasili E, Reich K. Assessing adherence factors in patients under topical treatment: development of the Topical Therapy Adherence Questionnaire (TTAQ). Arch Dermatol Res. 2014 Apr;306(3):287-97. doi: 10.1007/s00403-014-1446-x. Epub 2014 Feb 8.
PubMed 24509981Reich K, Zschocke I, Bachelez H, de Jong EMGJ, Gisondi P, Puig L, Warren RB, Ortland C, Mrowietz U; PSO-TOP study group. A Topical Treatment Optimization Programme (TTOP) improves clinical outcome for calcipotriol/betamethasone gel in psoriasis: results of a 64-week multinational randomized phase IV study in 1790 patients (PSO-TOP). Br J Dermatol. 2017 Jul;177(1):197-205. doi: 10.1111/bjd.15466. Epub 2017 Jun 6.
PubMed 28301043
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Outpatient Care in Mild to Moderate Psoriasis by a Newly Developed 'Topical Treatment Optimising Programme' - an International Study Using Daivobet®/Dovobet® Gel
- ClinicalTrials.gov ID
- NCT01587755
- Acronym / sponsor ID
- PSO-TOP / 055-006
- Conditions
- Mild to Moderate Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,852 participants (actual)
- Lead sponsor
- Kristian Reich, MD
- Collaborators
- LEO Pharma
- Study start
- Mar 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Apr 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.
A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board to overcome non-adherence problems.
Detailed description
A Topical Treatment Optimisation Programme (TTOP) has been developed by the sponsor together with Patient Boards and an Expert Advisory Board. This tool is created to address patients' non-adherence in topical therapy and the resulting underperformance of such treatments in controlling psoriatic disease. The study addresses the effect of the relationship between the patient and the health care professional, one of the important factors that can affect treatment adherence and therapeutic efficacy. The TTOP will be compared to standardised regular care (called 'non-TTOP'). It is intended to clinically show the importance of an optimised contact between the patient and health care professional.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Treatment Optimizing Program | Other | Other: TTOPOptimized care |
| non-Topical Treatment Optimizing Program | Other | Other: non-TTOPStandard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients aged at least 18 years
- Mild to moderate active plaque psoriasis with PGA ≥ 2 on the 7-point scale by Langley and Ellis and a Body Surface Area (BSA) of ≤ 10%
- Topical psoriasis treatment with coal or tar preparations, tazarotene, steroids, or vitamin D analogues, or combinations of steroids and vitamin D analogues (except gel combination products containing 50 micrograms calcipotriol/0.5mg betamethasone/g) or dithranol and its combination preparations over the last 8 weeks prior to Visit 1 (week 0)
- Written informed consent to participate in the study has been given prior to any study related procedures
Key exclusion criteria (18 listed)
- Severe renal insufficiency
- Severe hepatic disorders
- Known hyper calcaemia
- Erythrodermic, exfoliative, pustular or guttate psoriasis
- Facial or genital psoriasis
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 |
|---|---|---|
| TTOPPatient is taken care of in an intensified, optimised manner | Other | Topical Treatment Optimizing Program |
| non-TTOPStandard medical care | Other | non-Topical Treatment Optimizing Program |
Primary outcome
Physician Global Assessment (PGA)
Time frame: Up to 64 weeks; primary outcome assessed at week 8 after treatment start
PGA (Physician Global Assessment) will be assessed at all study visits. For week 8, the rate of patients with a PGA (as defined by Langley and Ellis 2004) of 0 or 1 will be calculated. This is the primary study parameter.
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 9 Mar 2015.
- Background: PubMed 25346093Reich K, Zschocke I, Bachelez H, de Jong EM, Gisondi P, Puig L, Warren RB, Mrowietz U; TTOP study group. Efficacy of a fixed combination of calcipotriol/betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicenter, randomized, controlled, prospective study. J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1156-63. doi: 10.1111/jdv.12774. Epub 2014 Oct 26.
- Background: PubMed 24895177Reich K, Mrowietz U, Karakasili E, Zschocke I. Development of an adherence-enhancing intervention in topical treatment termed the topical treatment optimization program (TTOP). Arch Dermatol Res. 2014 Sep;306(7):667-76. doi: 10.1007/s00403-014-1475-5. Epub 2014 Jun 4.
- Background: PubMed 24509981Zschocke I, Mrowietz U, Lotzin A, Karakasili E, Reich K. Assessing adherence factors in patients under topical treatment: development of the Topical Therapy Adherence Questionnaire (TTAQ). Arch Dermatol Res. 2014 Apr;306(3):287-97. doi: 10.1007/s00403-014-1446-x. Epub 2014 Feb 8.
- Derived from this study: PubMed 28301043Reich K, Zschocke I, Bachelez H, de Jong EMGJ, Gisondi P, Puig L, Warren RB, Ortland C, Mrowietz U; PSO-TOP study group. A Topical Treatment Optimization Programme (TTOP) improves clinical outcome for calcipotriol/betamethasone gel in psoriasis: results of a 64-week multinational randomized phase IV study in 1790 patients (PSO-TOP). Br J Dermatol. 2017 Jul;177(1):197-205. doi: 10.1111/bjd.15466. Epub 2017 Jun 6.
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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.
Kristian Reich, MD Prof. principal investigator
93 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TTOP and non-TTOP in people with Mild to Moderate Psoriasis, run by Kristian Reich, MD at 93 sites in 8 countries.
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 18 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 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in Germany, United Kingdom, France, Italy, Spain and 3 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Physician Global Assessment (PGA) (time frame: Up to 64 weeks; primary outcome assessed at week 8 after treatment start). 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 NCT01587755, which also lists 4 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 9 Mar 2015.