Contact information
Type
Scientific
Primary contact
Dr Alan Edwards
ORCID ID
Contact details
Maple Tree Cottage
Manstone Lane
Sidmouth
EX10 9TU
United Kingdom
+44 (0)1395 576 696
aedwards@vectis-allergy.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1387 T&R SkinP.02
Study information
Scientific title
A multicentre, double-blind, vehicle-controlled, randomised group-comparative study to evaluate the efficacy and safety of Altoderm™, a topically-applied sodium cromoglicate lotion, in the treatment of atopic dermatitis in children
Acronym
Study hypothesis
Sodium cromoglicate, a drug used in the treatment of allergic diseases, asthma, rhinitis, conjunctivitis and food allergy will be an effective and safe treatment for atopic dermatitis (eczema) in children, when applied topically to the skin.
Ethics approval
West Midlands Research Ethics Committee approved on the 20th January 2009 (ref: 08/H1208/57)
Study design
Multicentre double blind randomised parallel-group study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Atopic dermatitis (eczema)
Intervention
Active: a 4% solution of sodium cromoglicate in an aqueous lotion base
Control: the aqueous lotion base (vehicle)
Both treatments are applied to the affected areas of skin, twice daily. The total intervention period is 12 weeks; the total trial period is 16 weeks. There is a 4 week baseline period when all continue with existing treatment which must include an emollient. There is no follow-on period.
Intervention type
Drug
Phase
Phase III
Drug names
Sodium cromoglicate (Altoderm™)
Primary outcome measure
Change from baseline in SCORAD score and in the skin itch element of the SCORAD score at the end of the trial.
Secondary outcome measures
1. Change from baseline in Six Area, Six Sign Atopic Dermatitis (SASSAD) score, estimated at each clinic visit, 7 times in total
2. Change from baseline in severity of overall skin condition, skin itch and sleep disturbance as measured on a daily diary card, recorded daily by the parent throughout the baseline and treatment period and analysed in 2 week blocks
3. Change from baseline in usage of topical steroid therapy as determined by daily use as recorded on diary cards (proportion of days used and times used per day), and weight of topical steroid used, recorded daily by the parent and amount used weighed and recorded each day. The results will be analysed in 2 week blocks.
4. Change from baseline in steroid use as recorded by Investigator at each clinic visit, recorded daily by the parent and amount used weighed and recorded each day. The results will be analysed in 2 week blocks.
5. Change from baseline in quality of life questionnaire using the Children's Dermatology Life Quality Index (CDLQI) or Infant's Dermatitis Quality of Life Index (IDQOL), completed at visits 1, 3, 5 and 7
6. Global opinions (parent and investigator) of efficacy of treatment and acceptability, recorded at the final clinic visit
7. Incidence of adverse events
Overall trial start date
01/04/2009
Overall trial end date
31/07/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
At screening:
1. Children of either sex aged over 2 years but less than 12 years (after 2nd birthday and before 12th birthday)
2. Children with atopic dermatitis according to criteria of the UK Working Party for diagnostic criteria for atopic dermatitis. These are:
2.1. Must have an itchy skin condition (or report of scratching or rubbing in a child)
2.2. Three or more of the following:
2.2.1. History of itchiness in skin creases such as folds of the elbows, behind the knees, fronts of ankles, or around the neck (or the cheeks in children less than 4 years)
2.2.2. History of asthma or hay fever (or history of atopic disease in a first degree relative in children under 4 years)
2.2.3. General dry skin in the past year
2.2.4. Visible flexural eczema (or eczema affecting the cheeks or forehead and outer limbs in children under 4 years)
2.2.5. Onset in the first two years of life
3. Children who have a SCORing Atopic Dermatitis (SCORAD) of greater than or equal to 25 and less than or equal to 60
4. Children with atopic dermatitis whose parent(s) agree to:
4.1. Keep daily diary cards throughout the 16 weeks of the study, in order to record:
4.1.1. The weight and number of times, each day, they use their emollients and topical steroids during the baseline and emollients, topical steroids and test medication during the double-blind period
4.1.2. The child's eczema (skin condition, itching and sleep disturbance on a 4 point scale)
4.2. Ensure that their emollient is applied at least twice daily throughout the baseline period (weeks 1 - 4) but only as required during the double blind period (weeks 5 - 16)
5. Children who are able, in the investigator's opinion, to understand the issues, give signed, informed consent to participate in the trial
6. Children of parents (or legal guardians) who give signed, informed consent to participate in the trial
At entry to double blind period:
Children who, having been treated with emollients on a regular basis for 4 weeks (baseline period), have a SCORAD of greater than or equal to 25 and less than or equal to 60 and diary card scores for skin itch and overall skin condition of 2 or greater (using a 0 - 3 scale), on at least 4 days of the last 14 days of the baseline period.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
180
Participant exclusion criteria
1. Children with any other chronic disease with the exception of those associated allergic diseases (such as recurrent wheezing, allergic rhinitis and food allergy) should be excluded
2. Children who have cardiovascular, neurological, hepatic, renal, gastrointestinal, or other significant acute or chronic medical indication which, in the judgement of the investigator, might interfere with the study or required treatment
3. Patients who have received oral corticosteroids or corticosteroids by injection within the past 2 months
4. Patients currently using wet wrapping or calcineurin immunomodulators or have used wet wrapping during the previous 7 days or calcineurin immunomodulators during the previous 4 weeks
Recruitment start date
01/04/2009
Recruitment end date
31/07/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Maple Tree Cottage
Sidmouth
EX10 9TU
United Kingdom
Sponsor information
Organisation
Thornton & Ross Ltd (UK)
Sponsor details
Linthwaite Laboratories
Huddersfield
HD7 5QH
United Kingdom
+44 (0)1484 842 217
steveskilleter@thorntonross.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Thornton & Ross Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list