Adherence in Topical Treatment of Psoriasis
Can an App Supporting Psoriasis Patients Improve Adherence to Topical Treatment? A Single-blind Randomized Controlled Trial
1 other identifier
interventional
134
1 country
1
Brief Summary
Medical adherence to topical corticosteroid products in psoriasis patients is a main determinant for poor treatment effect. The investigators aim to test if a multifaceted intervention delivered in an app (MyPso QualityCareTM owned by Leo Pharma) for smartphones combined with an Electronic Monitor (EM) (Teslo) can improve medical adherence among psoriasis patients treated with a topical calcipotriol/betamethasone dipropionate foam combination (Cal/BD) (Enstilar©). The study is classified as a phase 4 study, since it is studied if improved use of Enstilar© results in improved treatment outcomes. Link to published study protocol: https://bmcdermatol.biomedcentral.com/articles/10.1186/s12895-018-0071-3 Link to published results from the study: https://onlinelibrary.wiley.com/doi/abs/10.1111/bjd.16667
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2016
CompletedFirst Posted
Study publicly available on registry
August 8, 2016
CompletedStudy Start
First participant enrolled
January 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2017
CompletedResults Posted
Study results publicly available
June 3, 2019
CompletedJune 3, 2019
February 1, 2019
4 months
August 3, 2016
December 11, 2017
February 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Adherent Participants
Rate of adherent patients, defined as dichotomized adherence rates obtained by number of days with applied medication with a selected cut-off of 80%, with adherence rates above 80% considered adherent
Week 4
Secondary Outcomes (2)
Dermatology Life Quality Index (DLQI)
Baseline, week 4, 8 and 26
Lattice-System Physician's Global Assessment (LS-PGA)
Week 4, 8 and 26
Study Arms (2)
App as intervention + Enstilar©
EXPERIMENTALPatients prescribed Calcipotriene + Betamethasone Dipropionatecutaneous foam receive the intervention EM with app for smartphone and conventional instruction from a nurse in the consultation.
Conventional instructions + Enstilar©
NO INTERVENTIONPatients receive conventional instructions from a nurse in the consultation in how to use prescribed Enstilar© with EM.
Interventions
Participants received Calcipotriene + Betamethasone Dipropionate once daily when needed for the entire study period.
App named MyPso SmarTopTM Version 1.0 (LEO Pharma) was used for 28 days by participants in the intervention arm.
Eligibility Criteria
You may qualify if:
- Psoriasis patients aged 18-75 years with mild-moderate psoriasis. It is mandatory that patients have a smartphone and basic skills for use of the smartphone.
You may not qualify if:
- aged under 18 and above 75 years, guttate psoriasis, severe degree of psoriasis, i.e. pustular and erythrodermic psoriasis, lack of smartphone and user skills for the smartphone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Dermatology and Allergy Centre
Odense C, 5000, Denmark
Related Publications (2)
Svendsen MT, Andersen F, Andersen KH, Andersen KE. Can an app supporting psoriasis patients improve adherence to topical treatment? A single-blind randomized controlled trial. BMC Dermatol. 2018 Feb 7;18(1):2. doi: 10.1186/s12895-018-0071-3.
PMID: 29415699BACKGROUNDSvendsen MT, Andersen F, Andersen KH, Pottegard A, Johannessen H, Moller S, August B, Feldman SR, Andersen KE. A smartphone application supporting patients with psoriasis improves adherence to topical treatment: a randomized controlled trial. Br J Dermatol. 2018 Nov;179(5):1062-1071. doi: 10.1111/bjd.16667. Epub 2018 Jul 5.
PMID: 29654699RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- M.D. Mathias Tiedemann Svendsen
- Organization
- Department of Dermatology, Odense University Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Mathias Tiedemann Svendsen, MD, PhD
Department of Dermatology and Allergy Centre, Odense University Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 3, 2016
First Posted
August 8, 2016
Study Start
January 9, 2017
Primary Completion
April 29, 2017
Study Completion
August 29, 2017
Last Updated
June 3, 2019
Results First Posted
June 3, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share