check_circleStudy Completed

Dermatitis, Atopic

Bayer Identifier:

18690

ClinicalTrials.gov Identifier:

NCT02627989

EudraCT Number:

Not Available

EU CT Number:

Not Available
An observational study investigating the treatment satisfaction of atopic dermatitis patients who have switched to ointment (W/O emulsion) formulation of Very Strong Class topical corticosteroids

Trial purpose

This study intends to investigate patient satisfaction of treatment with Ointment (W/O emulsion) formulations of Potency Class II topical corticosteroids (TCs) for atopic dermatitis (AD) patients in Japan. Objectives include measuring patient satisfaction, treatment adherence, itchiness, and AD severity scores.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • -Female and male patients with a diagnosis of atopic dermatitis who are treated with Fatty Ointment Potency Class II (Very strong class) TCs
    -Patients who are scheduled to change the formulation of the Potency Class II TC from Fatty Ointment to Ointment (Water in Oil; Water per Oil emulsion) as per investigator’s routine treatment practice
    -Patients who are aged over 20
    -Patients who are able to understand and sign a written informed consent


  • -Patients participating in an investigational program with interventions outside of routine clinical practice
     --Patients with any contraindication to TCs
     --Patients who are regarded as ineligible by the investigator
     --Patients who are pregnant or breastfeeding
     --For Period 2 (Spring-Summer), patients enrolled in the Period 1

Trial summary

Enrollment Goal
55
Trial Dates
December 2015 - January 2017
Phase
N/A
Could I Receive a placebo
No
Products
Diflucortolone valerate (BAY866146)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Tsu, 514-8507, Japan

Primary Outcome

  • Treatment satisfaction measured by Treatment Satisfaction Questionnaire for Medication (TSQM-9)
    A Patient Reported Outcome questionnaire assessing treatment satisfaction by recalling the last 2-3 weeks of treatment
    date_rangeTime Frame:
    10 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Treatment adherence measured by Morisky Medication Adherence Scale (MMAS-8-Item)
    date_rangeTime Frame:
    10 months
    enhanced_encryption
    Safety Issue:
    No
  • Itchiness according to Visual Analogue Scale (VAS)
    date_rangeTime Frame:
    10 months
    enhanced_encryption
    Safety Issue:
    No
  • Severity Scoring of Atopic Dermatitis (SCORAD)
    date_rangeTime Frame:
    10 months
    enhanced_encryption
    Safety Issue:
    No
  • Eczema Area and Severity Index (EASI)
    date_rangeTime Frame:
    10 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

An observational study investigating the treatment satisfaction of atopic dermatitis patients who have switched to ointment (W/O emulsion) formulation of Very Strong Class topical corticosteroids
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer products.