Atopic Dermatitis EczemaPhase 3NCT05136261
Evaluating the Efficacy and Tolerability of Ceradan Advanced Cream in the Treatment of Children With Atopic Dermatitis
A Phase 3 study testing Ceradan ® Advanced Cream and Basic cream in people with Atopic Dermatitis Eczema, run by KK Women's and Children's Hospital.
Trial summary
Atopic dermatitis is the most common chronic inflammatory skin condition worldwide and in Singapore. There is a significant impact on the quality of life as well as psychosocial burden on the patient and family. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Atopic Dermatitis Eczema
- What is being tested?
- Ceradan ® Advanced Cream and Basic cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2022to 1 Dec 2022
- Phase
- Phase 3
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents aged three to 16 years of age.
- Atopic dermatitis, in accordance with the U.K Working Party's Diagnostic Criteria.
- Moderate severity on both Eczema Area and Severity Index (EASI) and Scoring Atopic Dermatitis (SCORAD) scores. (I.e. 7.1-21 EASI and 29-48.9 SCORAD)
- Not currently infected eczema.
- Able to give informed consent or have a parent/guardian able and willing to give informed consent.
Who cannot join
- Known sensitivity or contact dermatitis to emollients, topical corticosteroids or any of its constituents.
- Currently infected eczema or frequent episodes of infected eczema requiring antibiotics.
- Currently on phototherapy, oral immunosuppressant, monoclonal antibodies for the treatment of eczema one month prior to start of study.
- Usage of any topical steroids or calcineurin inhibitors one week prior to start of study.
- Unable to give informed consent or have a parent/guarding unwilling to give consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Pilot Study to Evaluate the Efficacy and Tolerability of Ceradan Advanced Moisturising Skin Barrier Cream in the Treatment of Children and Adolescents With Moderate Atopic Dermatitis
Atopic dermatitis is the most common chronic inflammatory skin condition worldwide and in Singapore. There is a significant impact on the quality of life as well as psychosocial burden on the patient and family. Emollients are one of the cornerstones in the treatment of atopic dermatitis and are frequently prescribed with topical anti-inflammatories such as topical corticosteroids or topical calcineurin inhibitors to be used during active flares. Emollients that have additional anti-inflammatory properties may be able to reduce usage of topical corticosteroids or calcineurin inhibitors. In this study the investigators hope to evaluate the use of a patented ceramide dominant emollient which sustainably lowers the skin pH (Ceradan ® Advanced Cream, Hyphens Pharma, Singapore) with a commonly prescribed emollient in Singapore (Basic Aqua Cream, ICM Pharma, Singapore) for the treatment of moderate atopic dermatitis in children and adolescents.
Read the detailed description
This is a single center, randomized, double-blind, controlled study comparing a patented ceramide dominant emollient which sustainably lowers the skin pH with a standard commercial emollient for the treatment of moderate atopic dermatitis over two weeks. Subjects will be concomitantly treated with a low-potency topical steroid (Desonide lotion, Galderma, France) at the start of the trial to minimize any underlying skin inflammation for a more comparable baseline skin state.
Investigators and subjects are blinded to the treatment allocation. Subjects will be randomized using a random number sequence in a 1:1 ratio between the two arms. The study administrator will keep this information concealed in an opaque, sealed envelope to be disclosed upon completion of the trial. Allocation is secure and concealed with no further changes to be made.
Subjects will be dispensed a mild potency topical steroid (Desonide lotion, Galderma, France) and 480g of emollient (Ceradan ® Advanced Cream, Hyphens Pharma, Singapore or Basic Cream, ICM Pharma, Singapore) for the duration of the trial. The amount of steroid dispense would depend on the weight of the subject (<20kg: 1 bottle, 20-40kg: 2 bottles, >40kg: 3 bottles). Emollients will be dispensed in identical, unmarked containers.
Subjects should not wash the test areas with water or cleansing products (e.g. soap, body cleansers, and bath and shower products) within the 12 hours prior to scheduled visit at 2 weeks (visit 1) for assessment. Subjects will be instructed to use mild potency topical steroid (Desonide lotion, Galderma, France), twice a day to all affected areas with eczema for the first three days of the trial. The topical steroid supplied can be used after the initial period of treatment as needed and subjects will be asked to record down the areas that treated and the duration of treatment. Subjects will be asked to use the emollient provided twice a day on the face, trunk, and limbs. This is to be used after application of topical steroids, where applicable. Subjects will be asked to not apply any other topical leave-on products (e.g. creams, lotions, ointments) on the test areas, apart from those products dispensed for this trial during the entire duration of the study. Subjects will be asked to apply the emollient on the test areas the last time within 3-12 hours before the scheduled final visit (visit 1). Dispensed product will be weighed and recorded prior to the start of the trial and on completion of the trial to assess the compliance and amount of product used.
Schedule of Visits
Assessment at baseline (Visit 0) includes:
- Baseline demographics (age, race and gender)
- Past medical history and drug allergies
- Family and personal history of atopy
- Atopic dermatitis history (duration of illness, areas affected, treatments used including type, frequency of use and amount of steroids/emollients used 1 month before enrollment)
- EASI score
- SCORAD score
- Skin pH (HI99181 pH Meter for Skin, Hanna Instruments Inc., Singapore)
- Transepidermal water loss (TEWL) (Delfin Technologies)
- Stratum corneum (SC) hydration (Delfin Technologies)
- Peak pruritus NRS (numerical rating scale) score
- Patient-Oriented Eczema Measure (POEM) score
- Patient Eczema Severity Time (PEST) score [11] via iControl Eczema Application (Hyphens Pharma, Singapore)
- Children's Dermatology Quality of Life (C-DLQI) score
- Teenagers' Quality of Life (T-QoL©) score
- Dermatitis Family Impact (DFI) Questionnaire
Assessment after 2 weeks (Visit 1) includes:
- EASI (Eczema Area and Severity Index) score
- SCORAD (Severity Scoring of Atopic Dermatitis) score
- Skin pH (HI99181 pH Meter for Skin, Hanna Instruments Inc., Singapore)
- TEWL (Delfin Technologies)
- SC hydration (Delfin Technologies)
- Peak pruritus NRS (numerical rating scale) score
- Patient-Oriented Eczema Measure (POEM) score
- Patient Eczema Severity Time (PEST) score via iControl Eczema Application (Hyphens Pharma, Singapore)
- Children's Dermatology Quality of Life (C-DLQI) score
- Teenagers' Quality of Life (T-QoL©) score
- Dermatitis Family Impact (DFI) Questionnaire
In the event of a severe exacerbation of atopic dermatitis, Visit 1 will be brought forward to allow the patient to return for an assessment and any rescue or additional treatment as required. The assessment measures planned after 2 weeks will be done at this visit as well.
Data Collection Methods Personal data will be treated as strictly confidential. Data will be collected using a secured encrypted database and anonymized. Data will be collected at baseline visit and follow up visit 2 weeks later. Further clarification will be made to the patient and/or family over phone call if required.
Potential difficulties and risks
- Adverse reactions and/or contact dermatitis to emollients or its constituents
- Burning or stinging sensation
- Increased itch
- Localized skin infections
- Exacerbation of atopic dermatitis
- Slips and falls
- Conditions
- Atopic Dermatitis Eczema
- Being tested
- Ceradan ® Advanced Cream, Basic cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceradan ® Advanced CreamDevice
Ceradan ® Advanced Cream
Basic creamDevice
Basic cream
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Ceradan Advanced Moisturising Skin Barrier cream - applied twice a day Receives: Device: Ceradan ® Advanced Cream |
| Control | Placebo comparator | Aqueous Cream - applied twice a day Receives: Device: Basic cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in eczema severity and symptoms as determined by Eczema Area and Severity Index Score (EASI)
0=clear; 0.1-1=almost clear; 1.1-7=mild; 7.1-21=moderate; 21.1-50=severe; 50.1-72=very severe
Measured: 2 weeks
Improvement in eczema severity and symptoms as determined by Severity Scoring of Atopic Dermatitis score (SCORAD)
The SCORAD score range is between 0 and 103 points and defines three classes of AD severity (i.e. mild if SCORAD <25, moderate if 25 ≤ SCORAD ≤ 50 and severe if SCORAD > 50)
Measured: 2 weeks
Secondary outcomes (9)
Changes in skin pH
Changes in skin pH will be measured with a pH meter - a lower pH value is desirable as the intervention is proposed to lower skin pH and help improve eczema
Measured: 2 weeks
Changes in skin transepidermal water loss (TEWL) using a TEWL meter
A reduction in the amount of skin TEWL is desirable and expected for this trial
Measured: 2 weeks
Changes in skin stratum corneum hydration
An increase in skin stratum corneum hydration is desirable and expected for this trial
Measured: 2 weeks
Changes in POEM (Patient Oriented Eczema Measures) score
0-2 = clear/almost clear, 3-7 = mild, 8-16 = moderate, 17-24 = severe, and 25-28
Measured: 2 weeks
Changes in PEST (Patient Eczema Severity Time) score
PEST is a picture-based score with 5 images associated with caregiver/patient-reported global severity assessment ranging from 1 ("not at all unhappy") to 5 ("extremely unhappy")
Measured: 2 weeks
Changes in peak pruritus NRS (numerical response scale) scores
Peak Pruritus NRS score rates itch on a scale of 0-10 where 0 is no itch and 10 is the worst itch imaginable
Measured: 2 weeks
Changes in C-DLQI (Children's Dermatology Quality of Life Index) scores
The C-DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired
Measured: 2 weeks
Changes in T-QoL© scores
The T-QoL total score is calculated by summing the score of each of the 18 questions, resulting in a maximum of 36 and a minimum of 0.
The questions in the T-QoL are divided into three parts (domains):
Self-image (8 questions) Physical well-being and future aspirations (4 questions) Psychological impact and relationships (6 questions)
The T-QoL score can also be reported as three separate scores:
T-QoL self-image (score range 0-16) T-QoL physical/future (score range 0-8) T-QoL psychological/relationships (score range 0-12)
Measured: 2 weeks
Changes in DFI scores
The minimum DFI score is 0 (= no impact on life of family). The maximum DFI score is 30 (= maximum effect on life of family).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start10 Jan 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis EczemaStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136261
- Sponsor's protocol ID
- HYP2021/001
- Status last verified
- Oct 2021
- First submitted
- 24 Oct 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Efficacy and Tolerability of Ceradan Advanced Moisturising Skin Barrier Cream in the Treatment of Children and Adolescents With Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05136261
- Acronym / sponsor ID
- HYP2021/001
- Conditions
- Atopic Dermatitis Eczema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 10 Jan 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 29 Nov 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.
Atopic dermatitis is the most common chronic inflammatory skin condition worldwide and in Singapore. There is a significant impact on the quality of life as well as psychosocial burden on the patient and family. Emollients are one of the cornerstones in the treatment of atopic dermatitis and are frequently prescribed with topical anti-inflammatories such as topical corticosteroids or topical calcineurin inhibitors to be used during active flares. Emollients that have additional anti-inflammatory properties may be able to reduce usage of topical corticosteroids or calcineurin inhibitors. In this study the investigators hope to evaluate the use of a patented ceramide dominant emollient which sustainably lowers the skin pH (Ceradan ® Advanced Cream, Hyphens Pharma, Singapore) with a commonly prescribed emollient in Singapore (Basic Aqua Cream, ICM Pharma, Singapore) for the treatment of moderate atopic dermatitis in children and adolescents.
Detailed description
This is a single center, randomized, double-blind, controlled study comparing a patented ceramide dominant emollient which sustainably lowers the skin pH with a standard commercial emollient for the treatment of moderate atopic dermatitis over two weeks. Subjects will be concomitantly treated with a low-potency topical steroid (Desonide lotion, Galderma, France) at the start of the trial to minimize any underlying skin inflammation for a more comparable baseline skin state.
Investigators and subjects are blinded to the treatment allocation. Subjects will be randomized using a random number sequence in a 1:1 ratio between the two arms. The study administrator will keep this information concealed in an opaque, sealed envelope to be disclosed upon completion of the trial. Allocation is secure and concealed with no further changes to be made.
Subjects will be dispensed a mild potency topical steroid (Desonide lotion, Galderma, France) and 480g of emollient (Ceradan ® Advanced Cream, Hyphens Pharma, Singapore or Basic Cream, ICM Pharma, Singapore) for the duration of the trial. The amount of steroid dispense would depend on the weight of the subject (<20kg: 1 bottle, 20-40kg: 2 bottles, >40kg: 3 bottles). Emollients will be dispensed in identical, unmarked containers.
Subjects should not wash the test areas with water or cleansing products (e.g. soap, body cleansers, and bath and shower products) within the 12 hours prior to scheduled visit at 2 weeks (visit 1) for assessment. Subjects will be instructed to use mild potency topical steroid (Desonide lotion, Galderma, France), twice a day to all affected areas with eczema for the first three days of the trial. The topical steroid supplied can be used after the initial period of treatment as needed and subjects will be asked to record down the areas that treated and the duration of treatment. Subjects will be asked to use the emollient provided twice a day on the face, trunk, and limbs. This is to be used after application of topical steroids, where applicable. Subjects will be asked to not apply any other topical leave-on products (e.g. creams, lotions, ointments) on the test areas, apart from those products dispensed for this trial during the entire duration of the study. Subjects will be asked to apply the emollient on the test areas the last time within 3-12 hours before the scheduled final visit (visit 1). Dispensed product will be weighed and recorded prior to the start of the trial and on completion of the trial to assess the compliance and amount of product used.
Schedule of Visits
Assessment at baseline (Visit 0) includes:
- Baseline demographics (age, race and gender)
- Past medical history and drug allergies
- Family and personal history of atopy
- Atopic dermatitis history (duration of illness, areas affected, treatments used including type, frequency of use and amount of steroids/emollients used 1 month before enrollment)
- EASI score
- SCORAD score
- Skin pH (HI99181 pH Meter for Skin, Hanna Instruments Inc., Singapore)
- Transepidermal water loss (TEWL) (Delfin Technologies)
- Stratum corneum (SC) hydration (Delfin Technologies)
- Peak pruritus NRS (numerical rating scale) score
- Patient-Oriented Eczema Measure (POEM) score
- Patient Eczema Severity Time (PEST) score [11] via iControl Eczema Application (Hyphens Pharma, Singapore)
- Children's Dermatology Quality of Life (C-DLQI) score
- Teenagers' Quality of Life (T-QoL©) score
- Dermatitis Family Impact (DFI) Questionnaire
Assessment after 2 weeks (Visit 1) includes:
- EASI (Eczema Area and Severity Index) score
- SCORAD (Severity Scoring of Atopic Dermatitis) score
- Skin pH (HI99181 pH Meter for Skin, Hanna Instruments Inc., Singapore)
- TEWL (Delfin Technologies)
- SC hydration (Delfin Technologies)
- Peak pruritus NRS (numerical rating scale) score
- Patient-Oriented Eczema Measure (POEM) score
- Patient Eczema Severity Time (PEST) score via iControl Eczema Application (Hyphens Pharma, Singapore)
- Children's Dermatology Quality of Life (C-DLQI) score
- Teenagers' Quality of Life (T-QoL©) score
- Dermatitis Family Impact (DFI) Questionnaire
In the event of a severe exacerbation of atopic dermatitis, Visit 1 will be brought forward to allow the patient to return for an assessment and any rescue or additional treatment as required. The assessment measures planned after 2 weeks will be done at this visit as well.
Data Collection Methods Personal data will be treated as strictly confidential. Data will be collected using a secured encrypted database and anonymized. Data will be collected at baseline visit and follow up visit 2 weeks later. Further clarification will be made to the patient and/or family over phone call if required.
Potential difficulties and risks
- Adverse reactions and/or contact dermatitis to emollients or its constituents
- Burning or stinging sensation
- Increased itch
- Localized skin infections
- Exacerbation of atopic dermatitis
- Slips and falls
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: Ceradan ® Advanced CreamCeradan Advanced Moisturising Skin Barrier cream - applied twice a day |
| Control | Placebo comparator | Device: Basic creamAqueous Cream - applied twice a day |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children and adolescents aged three to 16 years of age.
- Atopic dermatitis, in accordance with the U.K Working Party's Diagnostic Criteria.
- Moderate severity on both Eczema Area and Severity Index (EASI) and Scoring Atopic Dermatitis (SCORAD) scores. (I.e. 7.1-21 EASI and 29-48.9 SCORAD)
- Not currently infected eczema.
- Able to give informed consent or have a parent/guardian able and willing to give informed consent.
Key exclusion criteria (5 listed)
- Known sensitivity or contact dermatitis to emollients, topical corticosteroids or any of its constituents.
- Currently infected eczema or frequent episodes of infected eczema requiring antibiotics.
- Currently on phototherapy, oral immunosuppressant, monoclonal antibodies for the treatment of eczema one month prior to start of study.
- Usage of any topical steroids or calcineurin inhibitors one week prior to start of study.
- Unable to give informed consent or have a parent/guarding unwilling to give consent.
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 ® Advanced CreamCeradan ® Advanced Cream | Device | Treatment |
| Basic creamBasic cream | Device | Control |
Primary outcome
Improvement in eczema severity and symptoms as determined by Eczema Area and Severity Index Score (EASI)
Time frame: 2 weeks
0=clear; 0.1-1=almost clear; 1.1-7=mild; 7.1-21=moderate; 21.1-50=severe; 50.1-72=very severe
Improvement in eczema severity and symptoms as determined by Severity Scoring of Atopic Dermatitis score (SCORAD)
Time frame: 2 weeks
The SCORAD score range is between 0 and 103 points and defines three classes of AD severity (i.e. mild if SCORAD <25, moderate if 25 ≤ SCORAD ≤ 50 and severe if SCORAD > 50)
9 secondary outcomes
Changes in skin pH
Time frame: 2 weeks
Changes in skin transepidermal water loss (TEWL) using a TEWL meter
Time frame: 2 weeks
Changes in skin stratum corneum hydration
Time frame: 2 weeks
Changes in POEM (Patient Oriented Eczema Measures) score
Time frame: 2 weeks
Changes in PEST (Patient Eczema Severity Time) score
Time frame: 2 weeks
Changes in peak pruritus NRS (numerical response scale) scores
Time frame: 2 weeks
Changes in C-DLQI (Children's Dermatology Quality of Life Index) scores
Time frame: 2 weeks
Changes in T-QoL© scores
Time frame: 2 weeks
Changes in DFI scores
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ceradan ® Advanced Cream and Basic cream in people with Atopic Dermatitis Eczema, run by KK Women's and Children's Hospital.
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 5 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: status not confirmed, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colin Tan, M.B,B.S (+65 9787 0645, colin.tan.weixuan@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in eczema severity and symptoms as determined by Eczema Area and Severity Index Score (EASI) (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 29 Nov 2021.