Improvement of Psoriasis Patients' Adherence to Topical Drugs

NCT04220554 | Completed Results DMC

• 1 other identifier: LF-OC-000048
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Psoriasis affects 2-4% of the Western adult population and is a socio-economic burden for patients and society. Topical drugs are recommended as first-line treatment for mild-to-moderate psoriasis, but low adherence is a barrier for treatment success. There is a need for improved patient support for psoriasis patients, which is suggested to improve long-term use of topical drugs. The project aims to test whether a patient-supporting intervention delivered by healthcare professionals can improve the use of topical drugs. The intervention design is based on experiences with previous adherence-improving studies consisting of digital support by conducting a systematic literature search and holding focus groups with patients as well as healthcare professionals. The intervention consists of shared decision-making with patients, nurses and doctors, frequent consultations, easy access to healthcare professionals through video or in-office consultations and holding patients accountable for taking the medication. The intervention will be tested in a randomized controlled trial: during a 48 week period, a group of patients (18-85 years of age) diagnosed with mild-to-moderate psoriasis and treated with topical drugs will be randomized to an intervention (n=40) or non-intervention group (n=40). The primary outcome will be severity of psoriasis and secondary outcomes primary adherence (i.e., rate of filled prescriptions) and quality of life. If the intervention can reduce the severity of psoriasis in a significant manner, there is a potential for a national implementation of the intervention.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Severity of Psoriasis

  Lattice-System Physician's Global Assessment (LS-PGA) (interval scale). From value 1 (no visible psoriasis) to 8 (severely affected by psoriasis).

  Change from baseline at week 48

Secondary Outcomes (2)

• Secondary Adherence

  Week 48

• Quality of Life (QOL)

  Change from baseline to week 48

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group: All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream. During the study period, a nurse or pharmaconomist will deliver; * Improved support and instructions to the patients * Patients will receive a diary and access to more consultations.

Other: Improved support by health-care professionals

Non-intervention group

NO INTERVENTION

All participants will be instructed how to use of the medication according to "the fingertip unit for topical steroids". All participants will be prescribed topical drugs based on shared decision between the prescriber and patient. The topical drugs will be either moderate corticosteroids (clobetasone-17-butyrate or hydrocortisone-17-butyrate), potent corticosteroids (betamethasone-17-valerate and betamethasone, mometasone furoate, fluocinolone acetonide or fluocinonide), very potent corticosteroids (clobetasol propionate), corticosteroids with antimicrobials (betamethasone and clioquinol, betamethasone and fusidic acid or fluocinolone acetonide and clioquinol), corticosteroid with calcipotriol or calcipotriol cream.

Interventions

Improved support by health-care professionals OTHER

Improved support to patients prescribed topical antipsoriatic drugs

Intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Dermatology and Allergy Centre

Odense C, 5000, Denmark

Location

Related Publications (3)

• Svendsen MT, Feldman SR, Moller S, Kongstad LP, Andersen KE. Long-term improvement of psoriasis patients' adherence to topical drugs: testing a patient-supporting intervention delivered by healthcare professionals. Trials. 2021 Oct 25;22(1):742. doi: 10.1186/s13063-021-05707-6.

  PMID: 34696820 BACKGROUND

• Svendsen MT, Feldman SR, Mejldal A, Moller S, Kongstad LP, Andersen KE. Regular support provided by dermatological nurses improves outcomes in patients with psoriasis treated with topical drugs: a randomized controlled trial. Clin Exp Dermatol. 2022 Dec;47(12):2208-2221. doi: 10.1111/ced.15370. Epub 2022 Oct 25.

  PMID: 35973788 RESULT

• Svendsen MT, Andersen KE, Feldman SR, Mejldal A, Moller S, Kongstad LP. An effective patient-supporting intervention for topical treatment of psoriasis is also cost-effective. Clin Exp Dermatol. 2023 Oct 25;48(11):1247-1254. doi: 10.1093/ced/llad272.

  PMID: 37585448 RESULT

Results Point of Contact

• Title: Consultant, MD, PhD Mathias Tiedemann Svendsen
• Organization: University of Southern Denmark

mtsvendsen@health.sdu.dk

0045 61265827

Study Officials

• Mathias T Svendsen, MD, PhD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in dermato-venereology, MD, PhD

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: January 7, 2020
• Study Start: June 19, 2020
• Primary Completion: September 16, 2021
• Study Completion: June 1, 2022
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)