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

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ClinicalTrials.gov Identifier: NCT02489643
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : July 7, 2015
Sponsor:
Information provided by (Responsible Party):
Giacomo Caldarola, Catholic University of the Sacred Heart

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.

Condition or disease Intervention/treatment Phase
Psoriasis Procedure: Individualized practical training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : May 2014
Actual Primary Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Receiving training
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 Intervention: No-receiving training



Primary Outcome Measures :
  1. Efficacy as measured by PASI improvement [ Time Frame: 1 month ]
  2. Efficacy as measured by BSA improvement [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Adherence as measured by days wherein gel was applied [ Time Frame: 1 month ]
  2. Adherence as measured by BSA/weight of gel applied rate [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Giacomo Caldarola, MD, PhD, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02489643     History of Changes
Other Study ID Numbers: 11134/14
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: July 7, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Calcipotriene
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents