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Adherence in Topical Treatment of Psoriasis
Phase 4 trial testing Calcipotriene + Betamethasone Dipropionate in Adherence in 134 participants. Completed in 29 August 2017.
| Lead sponsor | Odense University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 134 |
| Start date | 9 January 2017 |
| Primary completion | 29 April 2017 |
| Estimated completion | 29 August 2017 |
| Sites | 1 location across Denmark |
Odense University Hospital
Adults 18 to 75, any sex, with Adherence. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| App as Intervention + Enstilar© | 65 | 53 – 77 |
| Conventional Instructions + Enstilar© | 38 | 26 – 51 |
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 wo
| Group | Value | 95% CI |
|---|---|---|
| Conventional Instructions + Enstilar© | 4.54 | 3.47 – 5.61 |
| App as Intervention + Enstilar© | 4.12 | 3.27 – 4.98 |
| Group | Value | 95% CI |
|---|---|---|
| Conventional Instructions + Enstilar© | 5.17 | 3.92 – 6.43 |
| App as Intervention + Enstilar© | 4.59 | 3.71 – 5.48 |
| Group | Value | 95% CI |
|---|---|---|
| Conventional Instructions + Enstilar© | 5.00 | 3.69 – 6.31 |
| App as Intervention + Enstilar© | 4.23 | 3.25 – 5.21 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Conventional Instructions + Enstilar© | 1.46 | 1.17 – 1.75 |
| App + Enstilar© | 1.86 | 1.59 – 2.13 |
| Group | Value | 95% CI |
|---|---|---|
| Conventional Instructions + Enstilar© | 2.16 | 1.86 – 2.46 |
| App + Enstilar© | 2.25 | 1.96 – 2.54 |
| Group | Value | 95% CI |
|---|---|---|
| Conventional Instructions + Enstilar© | 1.80 | 1.49 – 2.11 |
| App + Enstilar© | 1.98 | 1.66 – 2.31 |
Time frame: Information on adverse events systematically reported at visits at baseline, week 4, 8 and 26 (6 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Conventional Instructions … | App as Intervention + Enst… |
|---|---|---|---|
| Infection in knee prosthesis | Musculoskeletal and connective tissue disorders | — | — |
| Reaction | System | Conventional Instructions … | App as Intervention + Enst… |
|---|---|---|---|
| Skin manifestations | Skin and subcutaneous tissue disorders | — | — |
| various musculoskelatal disorders | Musculoskeletal and connective tissue disorders | — | — |
| Lung and skin infections | Infections and infestations | — | — |
| Nausea | Ear and labyrinth disorders | — | — |
| Elevated liver enzymes | Hepatobiliary disorders | — | — |
| relapse of carcinoma in situ of the glottis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Worsening of chronic obstructive pumonary disease (COPD) | Respiratory, thoracic and mediastinal disorders | — | — |
| Elevated creatinin levels | Renal and urinary disorders | — | — |
| Fainting | Vascular disorders | — | — |
Most-reported serious reactions: Infection in knee prosthesis.
Data from ClinicalTrials.gov NCT02858713 adverse events section.
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
3 peer-reviewed publications reference this trial (live from Europe PMC):
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