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