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Trial record 79 of 154 for:    Dermatitis, Atopic, 8

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 (Ointment TS-AD)

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ClinicalTrials.gov Identifier: NCT02627989
Recruitment Status : Completed
First Posted : December 11, 2015
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment
Dermatitis, Atopic Drug: Diflucortolone valerate (Nerisona) Drug: Diflucortolone valerate (Texmeten)

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : December 10, 2015
Actual Primary Completion Date : November 17, 2016
Actual Study Completion Date : January 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Steroids

Group/Cohort Intervention/treatment
Diflucortolone valerate (Nerisona/Texmeten)
Adult patients with atopic dermatitis switching from diflucortolone-valerate fatty ointment to ointment (water/oil emulsion) during autumn/ winter (Nov to Feb) or spring/ summer (May to Aug)
Drug: Diflucortolone valerate (Nerisona)
Potency Class II (classified as Very Strong class in Japan) topical corticosteroids

Drug: Diflucortolone valerate (Texmeten)
Potency Class II (classified as Very Strong class in Japan) topical corticosteroids




Primary Outcome Measures :
  1. Treatment satisfaction measured by Treatment Satisfaction Questionnaire for Medication (TSQM-9) [ Time Frame: 10 months ]
    A Patient Reported Outcome questionnaire assessing treatment satisfaction by recalling the last 2-3 weeks of treatment


Secondary Outcome Measures :
  1. Treatment adherence measured by Morisky Medication Adherence Scale (MMAS-8-Item) [ Time Frame: 10 months ]
  2. Itchiness according to Visual Analogue Scale (VAS) [ Time Frame: 10 months ]
  3. Severity Scoring of Atopic Dermatitis (SCORAD) [ Time Frame: 10 months ]
  4. Eczema Area and Severity Index (EASI) [ Time Frame: 10 months ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited by the investigator who will also be the treating physician. As an observational study, only patients who the investigator plans on switching to the ointment (W/O emulsion) from fatty ointment formulation will be eligible to participate. Patients will be recruited for each seasonal phase and same patients may not necessarily be observed between the two seasonal phases.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627989


Locations
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Japan
Tsu, Mie, Japan, 514-8507
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02627989     History of Changes
Other Study ID Numbers: 18690
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Diflucortolone valerate
Diflucortolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs