Phase 4
Completed N=134
Adherence in Topical Treatment of Psoriasis
Adherence
Source: ClinicalTrials.gov NCT02858713 ↗
Enrolled (actual)
134
Serious AEs
0.8%
Results posted
Jun 2019
Primary outcomePrimary: Percentage of Adherent Participants — 65; 38 percentage of participants — p==0.004
◆ Published Evidence
Highly cited
▲ Trending
100citations · ~13 / year
A smartphone application supporting patients with psoriasis improves adherence to topical treatment: a randomized controlled trial.
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
Linked Publications (2)
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A smartphone application supporting patients with psoriasis improves adherence to topical treatment: a randomized controlled trial.
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Can an app supporting psoriasis patients improve adherence to topical treatment? A single-blind randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Adherent Participants |
65; 38 | =0.004 sig |
| SECONDARY Dermatology Life Quality Index (DLQI) |
4.54; 4.12; 5.17; 4.59; 5.00; 4.23 | =0.545 |
| SECONDARY Lattice-System Physician's Global Assessment (LS-PGA) |
1.46; 1.86; 2.16; 2.25; 1.80; 1.98 | 0.047 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02858713) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.