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Trial record 100 of 272 for:    Betamethasone

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
Sponsor:
Information provided by (Responsible Party):
Mathias Tiedemann Svendsen, Odense University Hospital

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


Condition or disease Intervention/treatment Phase
Adherence Drug: Calcipotriene + Betamethasone Dipropionate Device: App Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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


Arm Intervention/treatment
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

Device: App
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


  2. 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.




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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Denmark
Department of Dermatology and Allergy Centre
Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
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Principal Investigator: Mathias Tiedemann Svendsen, MD, PhD Department of Dermatology and Allergy Centre, Odense University Hospital
  Study Documents (Full-Text)

Documents provided by Mathias Tiedemann Svendsen, Odense University Hospital:

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Mathias Tiedemann Svendsen, MD, PhD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02858713     History of Changes
Other Study ID Numbers: 2016-002143-42
First Posted: August 8, 2016    Key Record Dates
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mathias Tiedemann Svendsen, Odense University Hospital:
psoriasis
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents