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Real-life Evaluation of the Daivobet® Gel Applicator

Real-life Evaluation of an Applicator, as a New Mode of Administration of Daivobet® Gel, on Adherence to Treatment and SAtisfaction of Patients With PSOriasis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02856542
Acronym
ASAP PSO
Enrollment
1560
Registered
2016-08-05
Start date
2016-05-23
Completion date
2017-06-30
Last updated
2017-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Keywords

Psoriasis vulgaris, scalp, topical, applicator, device

Brief summary

This study aims to describe the patient population being treated and evaluate their treatment adherence and treatment outcomes during treatment of scalp psoriasis with Daivobet® gel Applicator for 4 weeks.

Interventions

DRUGcalcipotriol/betamethasone dipropionate gel in Applicator

Topical treatment of scalp using applicator device. The study as such is non-interventional as the intervention has been decided prior to and independently from the inclusion of the patient in the cohort to be observed.

Sponsors

LEO Pharma
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years * Dermatologist or general practitioner has decided to initiate treatment with Daivobet® gel Applicator

Exclusion criteria

* Indication not within the approved labelling in France * Contraindication for treatment with calcipotriol or betamethasone dipropionate * Informed consent to participate in the study has not been obtained

Design outcomes

Primary

MeasureTime frameDescription
Morisky Medication Adherence Scale-82 weeksDegree of adherence to prescribed treatment

Secondary

MeasureTime frameDescription
Patient opinion on Applicator usability4 weeks5-point Likert scale
Patient overall satisfaction4 weeks4 point Likert scale
Patient Global Impression of Improvement2 weeks7 point Likert scale
Investigator's opinion on the properties of the ApplicatorBaseline5 point rating scale

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026