A trial of topical sodium cromoglicate in atopic dermatitis in children
| ISRCTN | ISRCTN43865436 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43865436 |
| Secondary identifying numbers | T&R.SkinP.01 |
- Submission date
- 14/09/2005
- Registration date
- 12/10/2005
- Last edited
- 14/08/2008
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Kai-Håkon Carlsen
Scientific
Scientific
Voksentoppen BKL
National Hospital (Rikshoapitalet)
Ullveien14
Oslo
NO 0791
Norway
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | T&R.SkinP.01 |
| Study objectives | Sodium cromoglicate lotion applied topically to the skin is more effective than the vehicle in the treatment of atopic dermatitis in children. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 Childrens Dermatology Life Quality Index (CDLQI) or Infant Life Quality Index |
| Overall study start date | 01/10/2005 |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 174 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 30/06/2007 |
Locations
Countries of recruitment
- Norway
- United Kingdom
Study participating centre
Voksentoppen BKL
Oslo
NO 0791
Norway
NO 0791
Norway
Sponsor information
Thornton and Ross Ltd (UK)
Industry
Industry
Stephen J Skilleter
Thornton & Ross Ltd
Linthwaite
Huddersfield
HD7 5QH
United Kingdom
| Website | http://www.thorntonross.com |
|---|---|
"ROR" |
https://ror.org/00frd0c49 |
Funders
Funder type
Industry
Thornton and 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? |
|---|---|---|---|---|---|
| Results article | Results | 01/02/2005 | Yes | No |
