Adherence in Topical Treatment of Psoriasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02858713|
Recruitment Status : Completed
First Posted : August 8, 2016
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
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:
Link to published results from the study:
|Condition or disease||Intervention/treatment||Phase|
|Adherence||Drug: Calcipotriene + Betamethasone Dipropionate Device: App||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Can an App Supporting Psoriasis Patients Improve Adherence to Topical Treatment? A Single-blind Randomized Controlled Trial|
|Actual Study Start Date :||January 9, 2017|
|Actual Primary Completion Date :||April 29, 2017|
|Actual Study Completion Date :||August 29, 2017|
Experimental: App as intervention + Enstilar©
Patients prescribed Calcipotriene + Betamethasone Dipropionatecutaneous foam receive the intervention EM with app for smartphone and conventional instruction from a nurse in the consultation.
Drug: Calcipotriene + Betamethasone Dipropionate
Participants received Calcipotriene + Betamethasone Dipropionate once daily when needed for the entire study period.
Other Name: Enstilar
App named MyPso SmarTopTM Version 1.0 (LEO Pharma) was used for 28 days by participants in the intervention arm.
Other Name: Mypso app
No Intervention: Conventional instructions + Enstilar©
Patients receive conventional instructions from a nurse in the consultation in how to use prescribed Enstilar© with EM.
- Percentage of Adherent Participants [ Time Frame: Week 4 ]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
- Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline, week 4, 8 and 26 ]
Change from baseline to week 4
Description of Dermatology Life Quality Index (DLQI): A score from 0-30 [0, patients' quality of life not affected; 30, patients' quality of life severely affected by the skin disease]. The DLQI-scale is a summary of 10 questions on subscales, where patients' report how severely their quality of life has been affected for the last week (patient reported outcome measurements (PROM), each subscale have a score from 0 (not affected by skin disease) to 3 (severely affected by skin disease).
The minimum score is 0 and the highest score is 30, a high score means worse outcome.
- Lattice-System Physician's Global Assessment (LS-PGA) [ Time Frame: Week 4, 8 and 26 ]
Change from baseline to week 4, 8 and 26
Lattice System Physican's Gloabal Assessment (LS-PGA) is a measure from 0-8 (0, patients skin clear; 8, patients' skin severely affected by psoriasis). The scale is a summary of three subscales: 1). thickness of psoriasis, 2). extent of scaling and 3). body surface ares (BSA) affected. The minimum score is 0 and the maximum score is 8, a high score represents a worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858713
|Department of Dermatology and Allergy Centre|
|Odense C, Denmark, 5000|
|Principal Investigator:||Mathias Tiedemann Svendsen, MD, PhD||Department of Dermatology and Allergy Centre, Odense University Hospital|