A clinical trial to evaluate the efficacy and safety of Altoderm™, a topically-applied sodium cromoglicate lotion, in the treatment of atopic dermatitis (eczema) in children
ISRCTN | ISRCTN02084571 |
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DOI | https://doi.org/10.1186/ISRCTN02084571 |
Secondary identifying numbers | 1387 T&R SkinP.02 |
- Submission date
- 24/03/2009
- Registration date
- 30/04/2009
- Last edited
- 24/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alan Edwards
Scientific
Scientific
Maple Tree Cottage
Manstone Lane
Sidmouth
EX10 9TU
United Kingdom
Phone | +44 (0)1395 576 696 |
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aedwards@vectis-allergy.com |
Study information
Study design | Multicentre double blind randomised parallel-group study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
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 |
Study objectives | 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(s) | West Midlands Research Ethics Committee approved on the 20th January 2009 (ref: 08/H1208/57) |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2009 |
Completion date | 31/07/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 2 Years |
Upper age limit | 12 Years |
Sex | Both |
Target number of participants | 180 |
Key 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. |
Key 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 |
Date of first enrolment | 01/04/2009 |
Date of final enrolment | 31/07/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Maple Tree Cottage
Sidmouth
EX10 9TU
United Kingdom
EX10 9TU
United Kingdom
Sponsor information
Thornton & Ross Ltd (UK)
Industry
Industry
Linthwaite Laboratories
Huddersfield
HD7 5QH
United Kingdom
Phone | +44 (0)1484 842 217 |
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steveskilleter@thorntonross.com | |
Website | http://www.thorntonross.com/ |
https://ror.org/00frd0c49 |
Funders
Funder type
Industry
Thornton & Ross Ltd (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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HRA research summary | 28/06/2023 | No | No |
Editorial Notes
24/06/2016: No publications found, verifying study status with principal investigator.