Atopic DermatitisNCT04976868
Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis
An observational study of Atopic Dermatitis, run by Mylan Inc. at 10 sites in China.
Trial summary
The primary objective of the present multicentre, prospective, non-interventional study (NIS) is gathering knowledge on the actual use and effectiveness of Elidel® in Chinese patients with mild to moderate AD affecting sensitive skin areas in routine clinical practice. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Pimecrolimus 1% Top Cream
- How many people
- 130 participants
- Where
- 10 sitesChina
- Study dates
- 18 Mar 2021to 31 Oct 2022
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chinese patients at least 2 years old with mild to moderate atopic dermatitis affecting sensitive skin areas
Who may be able to join
- Patients of Chinese ethnicity
- Patients at least 2 years old
- Signed informed consent from patient and if applicable from parent(s) or legal guardian(s) in compliance with local requirements
- Patients with mild to moderate AD and depending on the age:
- Patients 2-12 years must have:
- SCORAD Index < 50
Show all 9Show fewer
- Patients 13 years and older must have:
- Affecting sensitive skin areas (e.g. face, intertriginous sites, anogenital area)
- SCORAD Index < 50 and IGA in sensitive skin areas ≤ 3
Who cannot join
- Patients for whom Elidel® is not recommended accordingly to the Package Insert
- Patients with severe atopic dermatitis (SCORAD Index ≥ 50 or IGA in sensitive skin > 3)
- Receiving systemic glucocorticoids, antibiotics, antifungals, immunomodulators, inhibitors, antihistamines and ultraviolet radiation therapy within the last 4 weeks before inclusion;
- Receiving any topical AD-effective drugs within the last 2 weeks before inclusion;
- Pregnant and/or breastfeeding women
- Patients or parent(s) / legal guardian (as applicable) that are not able to fulfil study requirements according to physician's opinion
- Patients or parent(s) / legal guardian (as applicable) that refuse to participate to the study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Beijing children's Hospital, Capital Medical University
Beijing
Beijing Hospital
Beijing
Children's Hospital Capital Institute of Pediatrics
Beijing
Peking University First Hospital
Beijing
Peking University Third Hospital
Beijing
Children's hospital of Chongqing medical university
Chongqing
The third affiliated hospital, sun yat-sen university
Guangzhou
The first Hospital of China Medical University
Shenyang
Peking University Shenzhen Hospital
Shenzhen
Tongji Medical College Huazhong University of Science & Technology
Wuhan
About this study
The primary objective of the present multicentre, prospective, non-interventional study (NIS) is gathering knowledge on the actual use and effectiveness of Elidel® in Chinese patients with mild to moderate AD affecting sensitive skin areas in routine clinical practice.
- Conditions
- Atopic Dermatitis
- Being tested
- Pimecrolimus 1% Top Cream
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pimecrolimus 1% Top CreamDrug
Elidel® as prescribed within routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Pimecrolimus Cream 1% - Elidel® | Elidel® as prescribed within routine clinical practice Receives: Drug: Pimecrolimus 1% Top Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD
The primary outcome measure is the "change from baseline in SCORAD INDEX". The achievable score in SCORAD INDEX range from 0 to 103. The classification of severity would be as follows mild (<25), moderate (25-50) and severe (≥50).
Measured: The study ends after the Maintenance Period of at least 3 months allowing certain flexibility to respond to the routine practice. End of Study will be approx. 6 months after the inclusion depending length of the Elidel® Treatment Period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start18 Mar 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medicine Meda Pharmaceutical Information Consultancy (Beijing) Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976868
- Sponsor's protocol ID
- 3328
- Status last verified
- May 2023
- First submitted
- 15 Jul 2021
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04976868
- Acronym / sponsor ID
- 3328
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medicine Meda Pharmaceutical Information Consultancy (Beijing) Co., Ltd.
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 26 Jul 2021 (actual)
- 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.
The primary objective of the present multicentre, prospective, non-interventional study (NIS) is gathering knowledge on the actual use and effectiveness of Elidel® in Chinese patients with mild to moderate AD affecting sensitive skin areas in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pimecrolimus Cream 1% - Elidel® | – | Drug: Pimecrolimus 1% Top CreamElidel® as prescribed within routine clinical practice |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese patients at least 2 years old with mild to moderate atopic dermatitis affecting sensitive skin areas
Key inclusion criteria (9 listed)
- Patients of Chinese ethnicity
- Patients at least 2 years old
- Signed informed consent from patient and if applicable from parent(s) or legal guardian(s) in compliance with local requirements
- Patients with mild to moderate AD and depending on the age:
- Patients 2-12 years must have:
Key exclusion criteria (7 listed)
- Patients for whom Elidel® is not recommended accordingly to the Package Insert
- Patients with severe atopic dermatitis (SCORAD Index ≥ 50 or IGA in sensitive skin > 3)
- Receiving systemic glucocorticoids, antibiotics, antifungals, immunomodulators, inhibitors, antihistamines and ultraviolet radiation therapy within the last 4 weeks before inclusion;
- Receiving any topical AD-effective drugs within the last 2 weeks before inclusion;
- Pregnant and/or breastfeeding women
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 |
|---|---|---|
| Pimecrolimus 1% Top CreamElidel® as prescribed within routine clinical practice | Drug | Pimecrolimus Cream 1% - Elidel® |
Primary outcome
SCORAD
Time frame: The study ends after the Maintenance Period of at least 3 months allowing certain flexibility to respond to the routine practice. End of Study will be approx. 6 months after the inclusion depending length of the Elidel® Treatment Period.
The primary outcome measure is the "change from baseline in SCORAD INDEX". The achievable score in SCORAD INDEX range from 0 to 103. The classification of severity would be as follows mild (<25), moderate (25-50) and severe (≥50).
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 24 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Mylan Inc. at 10 sites in China.
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 9 inclusion and 7 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. 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?
SCORAD (time frame: The study ends after the Maintenance Period of at least 3 months allowing certain flexibility to respond to the routine practice. End of Study will be approx. 6 months after the inclusion depending length of the Elidel® Treatment Period.). 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 24 May 2023.