Atopic DermatitisCOPESNCT02073591
Correlation Study Between PEST and SCORAD in Management of Atopic Dermatitis With Ceradan® Regimen
An observational study of Atopic Dermatitis, run by Hyphens Pharma Pte Ltd at 2 sites in Singapore.
Trial summary
This is a prospective, open label, single arm, and observational and multicenter study to assess the correlation between PEST and SCORAD scores in the management of AD with the Ceradan® regimen. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Ceradan Cream and Ceradan Wash
- How many people
- 58 participants
- Where
- 2 sitesSingapore
- Study dates
- Mar 2014to Nov 2014
- 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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children Aged Six Months to Six Years with Atopic Dermatitis
Who may be able to join
- Male and female children aged ≥6 months to ≤6 years
- Baseline PEST score of 3- 4
- Diagnosis of mild to moderate atopic dermatitis, with grading of 3 to11, as per the NESS
- Diagnosis of current flare (increased dryness, itching, redness, swelling and general irritability) at baseline visit according to Investigator's judgement
- Patients who have not visited the dermatologist before (dermatologist-naïve)
- Agree to participate and provide written consent by parent or guardian (and assent if applicable)
Who cannot join
- History of severe episodes of atopic dermatitis (for example: oozing, crusts)
- Clinical signs of skin infection (viral, bacterial or fungal)
- Grading of >11 as defined by the Nottingham Eczema Severity Score (NESS) within 3 months prior to study inclusion
- Known reaction or allergy to test drug or excipients or steroids
- History of cutaneous or systemic viral (including HIV or AIDS), cutaneous mycotic or cutaneous bacterial disease requiring a topical or systemic therapy during the study period
- Patients who are receiving any investigational drug or who have taken part in a clinical study with an investigational drug within three months prior to the start of study treatment
Show all 10Show fewer
- The patient has been exposed to below therapy within the set timeframe:
- Systemic administration of corticosteroid - four weeks; ii. Systemic administration of immunosuppressive drugs - four weeks; iii. UV therapy four weeks
- Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results
- Parents/guardians may be unable to complete the patient diaries or questionnaires
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
KK Women's and Children's Hospital
Singapore
National Skin Centre
Singapore
About this study
Official title: A Phase IV, Open Label, Single Arm, Multicenter, Observational Study to Evaluate the Correlation Between PEST and SCORAD Score in the Management of Atopic Dermatitis With Use of Ceradan® Regimen in Children Aged Six Months to Six Years
This is a prospective, open label, single arm, and observational and multicenter study to assess the correlation between PEST and SCORAD scores in the management of AD with the Ceradan® regimen.
Read the detailed description
All eligible patients shall apply permitted topical steroid(s) according to standard local practice
For the entire study period, patients should apply Ceradan Cream® liberally twice daily or more, if required and use a non-soap based wash once or twice daily.
At the screening visit, patients will receive a diary card and will be asked to track their atopic dermatitis symptoms for 12 weeks.
Retrospective information on other topical treatments used will be collected at baseline.
- Conditions
- Atopic Dermatitis
- Being tested
- Ceradan Cream, Ceradan Wash
- Keywords
- Children, Atopic Dermatitis, Ceradan, PEST, SCORAD
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceradan CreamOther
Ceradan WashOther
| Study group | Role | What they receive |
|---|---|---|
| Ceradan Regimen | Ceradan Cream and Ceradan Wash Receives: Other: Ceradan Cream; Other: Ceradan Wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the mean Patient Eczema Severity Time (PEST) score and mean Scoring Atopic Dermatitis (SCORAD) Index at Week 4 and Week 12, as compared to baseline
Correlation will be assessed by Pearson correlation at baseline, Week 4 and Week 12 between both scores. Karl Pearson correlation coefficient (ρ) will be provided. Percent Change from Baseline will be calculated for Week 4 and Week 12 and correlation will also be calculated for it.
Measured: 12 weeks
Secondary outcomes (2)
Efficacy by change in SCORAD score at Week 4 and Week 12 as compared to baseline
Measured: 12 weeks
Efficacy by change in AUC PEST score at Week 4, Week 12 as compared to baseline and three months prior to baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyphens Pharma Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073591
- Sponsor's protocol ID
- HYP2013/001
- Acronym
- COPES
- Status last verified
- Nov 2015
- First submitted
- 19 Feb 2014
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Koh MJ, Giam YC, Liew HM, Foong AY, Chong JH, Wong SMY, Tang MBY, Ho MSL, Tan LS, Mason JM, Cork MJ. Comparison of the Simple Patient-Centric Atopic Dermatitis Scoring System PEST with SCORAD in Young Children Using a Ceramide Dominant Therapeutic Moisturizer. Dermatol Ther (Heidelb). 2017 Sep;7(3):383-393. doi: 10.1007/s13555-017-0186-1. Epub 2017 Jun 14.
PubMed 28616853
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open Label, Single Arm, Multicenter, Observational Study to Evaluate the Correlation Between PEST and SCORAD Score in the Management of Atopic Dermatitis With Use of Ceradan® Regimen in Children Aged Six Months to Six Years
- ClinicalTrials.gov ID
- NCT02073591
- Acronym / sponsor ID
- COPES / HYP2013/001
- Conditions
- Atopic Dermatitis
- Keywords
- Children, Atopic Dermatitis, Ceradan, PEST, SCORAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hyphens Pharma Pte LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 27 Feb 2014 (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 is a prospective, open label, single arm, and observational and multicenter study to assess the correlation between PEST and SCORAD scores in the management of AD with the Ceradan® regimen.
Detailed description
All eligible patients shall apply permitted topical steroid(s) according to standard local practice
For the entire study period, patients should apply Ceradan Cream® liberally twice daily or more, if required and use a non-soap based wash once or twice daily.
At the screening visit, patients will receive a diary card and will be asked to track their atopic dermatitis symptoms for 12 weeks.
Retrospective information on other topical treatments used will be collected at baseline.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceradan Regimen | – | Other: Ceradan Cream, Other: Ceradan WashCeradan Cream and Ceradan Wash |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children Aged Six Months to Six Years with Atopic Dermatitis
Key inclusion criteria (6 listed)
- Male and female children aged ≥6 months to ≤6 years
- Baseline PEST score of 3- 4
- Diagnosis of mild to moderate atopic dermatitis, with grading of 3 to11, as per the NESS
- Diagnosis of current flare (increased dryness, itching, redness, swelling and general irritability) at baseline visit according to Investigator's judgement
- Patients who have not visited the dermatologist before (dermatologist-naïve)
Key exclusion criteria (10 listed)
- History of severe episodes of atopic dermatitis (for example: oozing, crusts)
- Clinical signs of skin infection (viral, bacterial or fungal)
- Grading of >11 as defined by the Nottingham Eczema Severity Score (NESS) within 3 months prior to study inclusion
- Known reaction or allergy to test drug or excipients or steroids
- History of cutaneous or systemic viral (including HIV or AIDS), cutaneous mycotic or cutaneous bacterial disease requiring a topical or systemic therapy during the study period
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 |
|---|---|---|
| Ceradan Cream | Other | Ceradan Regimen |
| Ceradan Wash | Other | Ceradan Regimen |
Primary outcome
Correlation between the mean Patient Eczema Severity Time (PEST) score and mean Scoring Atopic Dermatitis (SCORAD) Index at Week 4 and Week 12, as compared to baseline
Time frame: 12 weeks
Correlation will be assessed by Pearson correlation at baseline, Week 4 and Week 12 between both scores. Karl Pearson correlation coefficient (ρ) will be provided. Percent Change from Baseline will be calculated for Week 4 and Week 12 and correlation will also be calculated for it.
2 secondary outcomes
Efficacy by change in SCORAD score at Week 4 and Week 12 as compared to baseline
Time frame: 12 weeks
Efficacy by change in AUC PEST score at Week 4, Week 12 as compared to baseline and three months prior to baseline
Time frame: 12 weeks
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 5 Nov 2015.
- Derived from this study: PubMed 28616853Koh MJ, Giam YC, Liew HM, Foong AY, Chong JH, Wong SMY, Tang MBY, Ho MSL, Tan LS, Mason JM, Cork MJ. Comparison of the Simple Patient-Centric Atopic Dermatitis Scoring System PEST with SCORAD in Young Children Using a Ceramide Dominant Therapeutic Moisturizer. Dermatol Ther (Heidelb). 2017 Sep;7(3):383-393. doi: 10.1007/s13555-017-0186-1. Epub 2017 Jun 14.
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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.
2 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 Hyphens Pharma Pte Ltd at 2 sites in Singapore.
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 6 inclusion and 10 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 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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?
Correlation between the mean Patient Eczema Severity Time (PEST) score and mean Scoring Atopic Dermatitis (SCORAD) Index at Week 4 and Week 12, as compared to baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02073591, which also lists 1 linked publication.
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 5 Nov 2015.