Condition category
Skin and Connective Tissue Diseases
Date applied
14/09/2005
Date assigned
12/10/2005
Last edited
14/08/2008
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

Prof Kai-Håkon Carlsen

ORCID ID

Contact details

Voksentoppen BKL
National Hospital (Rikshoapitalet)
Ullveien14
Oslo
NO 0791
Norway

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

T&R.SkinP.01

Study information

Scientific title

Acronym

T&R.SkinP.01

Study hypothesis

Sodium cromoglicate lotion applied topically to the skin is more effective than the vehicle in the treatment of atopic dermatitis in children.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Atopic dermatitis

Intervention

Parallel group comparative randomised controlled trial:
1. 4% sodium cromoglicate in an aqueous lotion
2. The aqueous lotion vehicle

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The change in the SCORAD assessment score between end of baseline and after 12 weeks treatment.

Secondary outcome measures

1. The change in overall skin condition, itch and sleep disturbance recorded on the daily diary cards
2. The change in topical corticosteroid and/or immunomodulator drug use as recorded on the daily diary cards and by weighing of the tubes
3. The global assessments recorded at the end of the study by the parent and investigator
4. The change in Children’s Dermatology Life Quality Index (CDLQI) or Infant Life Quality Index

Overall trial start date

01/10/2005

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children of either sex aged between 1 and 12 years (after the first birthday and before the 13th birthday)
2. Children with atopic dermatitis according to 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. Plus 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 with atopic dermatitis who at the Screening Visit (Visit 1) and at Visit 2 exhibit a score using the SCORing Atopic Dermatitis (SCORAD) scoring system for atopic dermatitis of greater than or equal to 25
4. Children of parents, one of whom gives signed, informed consent to participate in the trial

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

174

Participant exclusion criteria

1. Children with any chronic disease other than associated allergic diseases (which include recurrent wheezing, allergic rhinitis and food allergy)
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 require treatment
3. Patients who have received oral corticosteroids or corticosteroids by injection within the past 3 months

Recruitment start date

01/10/2005

Recruitment end date

30/06/2007

Locations

Countries of recruitment

Norway, United Kingdom

Trial participating centre

Voksentoppen BKL
Oslo
NO 0791
Norway

Sponsor information

Organisation

Thornton and Ross Ltd (UK)

Sponsor details

Stephen J Skilleter
Thornton & Ross Ltd
Linthwaite
Huddersfield
HD7 5QH
United Kingdom

Sponsor type

Industry

Website

http://www.thorntonross.com

Funders

Funder type

Industry

Funder name

Thornton and 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

Results in http://www.ncbi.nlm.nih.gov/pubmed/15727648

Publication citations

  1. Results

    Stainer R, Matthews S, Arshad SH, McDonald S, Robinson J, Schapira C, Foote KD, Baird-Snell M, Gregory T, Pollock I, Stevens MT, Edwards AM, Efficacy and acceptability of a new topical skin lotion of sodium cromoglicate (Altoderm) in atopic dermatitis in children aged 2-12 years: a double-blind, randomized, placebo-controlled trial., Br. J. Dermatol., 2005, 152, 2, 334-341, doi: 10.1111/j.1365-2133.2004.06303.x.

Additional files

Editorial Notes