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

Psoriasis Clinical Trial

Official title:

Role of an Individualized Medical Training in Improving Efficacy and Adherence to a 4-week Treatment With Calcipotriol and Betamethasone Dipropionate Gel for Mild-to-moderate Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489643
• Other study ID #: 11134/14
• Status: Completed
• Phase: N/A
• First received: June 29, 2015
• Last updated: July 2, 2015
• Start date: May 2014

Study information

• Verified date: July 2015
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Procedure:
• Individualized practical training

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy as measured by PASI improvement		1 month	No
Primary	Efficacy as measured by BSA improvement		1 month	No
Secondary	Adherence as measured by days wherein gel was applied		1 month	No
Secondary	Adherence as measured by BSA/weight of gel applied rate		1 month	No