Dermatitis, AtopicOintment TS-ADNCT02627989
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
An observational study of Dermatitis, Atopic, run by LEO Pharma at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Diflucortolone valerate (Nerisona) and Diflucortolone valerate (Texmeten)
- How many people
- 55 participants
- Where
- 1 siteJapan
- Study dates
- 10 Dec 2015to 17 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dermatitis, Atopic
- Being tested
- Diflucortolone valerate (Nerisona), Diflucortolone valerate (Texmeten)
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diflucortolone valerate (Nerisona)Drug
Potency Class II (classified as Very Strong class in Japan) topical corticosteroids
Diflucortolone valerate (Texmeten)Drug
Potency Class II (classified as Very Strong class in Japan) topical corticosteroids
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Diflucortolone valerate (Nerisona); Drug: Diflucortolone valerate (Texmeten) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 months
Secondary outcomes (4)
Treatment adherence measured by Morisky Medication Adherence Scale (MMAS-8-Item)
Measured: 10 months
Itchiness according to Visual Analogue Scale (VAS)
Measured: 10 months
Severity Scoring of Atopic Dermatitis (SCORAD)
Measured: 10 months
Eczema Area and Severity Index (EASI)
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study start10 Dec 2015
- Primary completion17 Nov 2016
- Study completion17 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627989
- Sponsor's protocol ID
- 18690
- Acronym
- Ointment TS-AD
- Status last verified
- Jan 2018
- First submitted
- 9 Dec 2015
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02627989
- Acronym / sponsor ID
- Ointment TS-AD / 18690
- Conditions
- Dermatitis, Atopic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- 10 Dec 2015 (actual)
- Primary completion
- 17 Nov 2016 (actual)
- Study completion
- 17 Jan 2017 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diflucortolone valerate (Nerisona/Texmeten) | – | Drug: Diflucortolone valerate (Nerisona), Drug: Diflucortolone valerate (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) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diflucortolone valerate (Nerisona)Potency Class II (classified as Very Strong class in Japan) topical corticosteroids | Drug | Diflucortolone valerate (Nerisona/Texmeten) |
| Diflucortolone valerate (Texmeten)Potency Class II (classified as Very Strong class in Japan) topical corticosteroids | Drug | Diflucortolone valerate (Nerisona/Texmeten) |
Primary outcome
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
4 secondary outcomes
Treatment adherence measured by Morisky Medication Adherence Scale (MMAS-8-Item)
Time frame: 10 months
Itchiness according to Visual Analogue Scale (VAS)
Time frame: 10 months
Severity Scoring of Atopic Dermatitis (SCORAD)
Time frame: 10 months
Eczema Area and Severity Index (EASI)
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis, Atopic, run by LEO Pharma at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment satisfaction measured by Treatment Satisfaction Questionnaire for Medication (TSQM-9) (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.