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
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

Maple Tree Cottage
Manstone Lane
Sidmouth
EX10 9TU
United Kingdom

Phone	+44 (0)1395 576 696
Email	aedwards@vectis-allergy.com

Study information

Study design	Multicentre double blind randomised parallel-group study
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
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

Sponsor information

Thornton & Ross Ltd (UK)
Industry

Linthwaite Laboratories
Huddersfield
HD7 5QH
United Kingdom

Phone	+44 (0)1484 842 217
Email	steveskilleter@thorntonross.com
Website	http://www.thorntonross.com/
"ROR"	https://ror.org/00frd0c49

Funders

Funder type

Industry

Thornton & Ross Ltd (UK)

No information available

Results and Publications

Intention to publish date
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?
HRA research summary			28/06/2023	No	No

Editorial Notes

24/06/2016: No publications found, verifying study status with principal investigator.