Phase 4
N=134
Adherence in Topical Treatment of Psoriasis
Adherence
Bottom Line
View on ClinicalTrials.gov: NCT02858713 ↗Enrolled (actual)
134
Serious AEs
0.8%
Results posted
Jun 2019
Primary outcome: Primary: Percentage of Adherent Participants — 65; 38 percentage of participants — p==0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Calcipotriene + Betamethasone Dipropionate (Drug); App (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Odense University Hospital
- Primary completion
- Apr 2017
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 |
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
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). 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.