Individualized Medical Training and Calcipotriol and Beta... | NCT02489643

Studies
Individualized Medical Training and Calcipotriol and Betamethasone Dipropionate Gel in Plaque Psoriasis

NCT02489643

Sponsor

Catholic University of the Sacred Heart

Status

Completed

Last Update Posted

Jul 7, 2015Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Psoriasis

Interventions

Individualized practical training

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

May 2015Actual

Completion Date

Not provided

First Submitted Date

Jun 29, 2015

First Submission Date that Met QC Criteria

Jul 1, 2015

First Posted Date

Jul 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2015

Last Update Posted Date

Jul 7, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giacomo Caldarola, MD, PhD, Catholic University of the Sacred HeartPrincipal Investigator

Lead Sponsor

Catholic University of the Sacred HeartOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Individualized practical training	Procedure		Receiving training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy as measured by PASI improvement		1 month
Efficacy as measured by BSA improvement		1 month

Secondary Outcomes

Measure	Description	Time Frame
Adherence as measured by days wherein gel was applied		1 month
Adherence as measured by BSA/weight of gel applied rate		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided