NCT02489643

Brief Summary

The aim of the study will be to evaluate the impact of this individualized practical training on efficacy (evaluated by Psoriasis Area and Severity Index (PASI) and Body Surface Area (BSA) score performed by a physician blinded to the study groups) and adherence (calculated as days wherein gel was applied and as BSA/weight of gel applied rate) to a 4 week long treatment with dovobet gel. On the other hand, the investigators will evaluate in both groups as demographic (as sex, age, job,..) or disease (as severity, duration, impact of quality of life,..) characteristics influence the adherence to the treatment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

June 29, 2015

Last Update Submit

July 2, 2015

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

  • Efficacy as measured by PASI improvement

    1 month

  • Efficacy as measured by BSA improvement

    1 month

Secondary Outcomes (2)

  • Adherence as measured by days wherein gel was applied

    1 month

  • Adherence as measured by BSA/weight of gel applied rate

    1 month

Study Arms (2)

Receiving training

EXPERIMENTAL

Patients will be visited and receive information about the prescribed topical treatment according to the normal course and procedure of an outpatient visit at our institution. At the end of the visit, they will also receive practical instructions on dosages and application modalities of the topical therapy.

Procedure: Individualized practical training

No-receiving training

NO INTERVENTION

Interventions

Individualized practical trainingPROCEDURE
Receiving training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of psoriasis will be maid mainly on clinical findings. If doubts, a skin sample will be obtained and evaluated by histopathological examination.

You may not qualify if:

  • Patients with palmoplantar, scalp, inverse, erythrodermic, guttate, pustular psoriasis will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 3, 2015

Study Start

May 1, 2014

Primary Completion

May 1, 2015

Last Updated

July 7, 2015

Record last verified: 2015-07