Condition category
Skin and Connective Tissue Diseases
Date applied
24/03/2009
Date assigned
30/04/2009
Last edited
24/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.thorntonross.com/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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