Atopic dermatitis MedDRA version: 4.0 Level: LLT Classification code 10012438
Conditions
Interventions
Product Name: Altoderm
Pharmaceutical Form: Cream
INN or Proposed INN: Cromoglicic acid
CAS Number: 15826-37-6
Other descriptive name: C
Sponsors
Thornton & Ross Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At screening »Children of either sex aged between 1 and 16 years. »Children with atopic dermatitis according to criteria according to the UK Working Party for diagnostic criteria for atopic dermatitis [1]. These are: lMust have an itchy skin condition (or report of scratching or rubbing in a child). lPlus three or more of the following –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). –History of asthma or hay fever (or history of atopic disease in a first degree relative in children under 4 years) –General dry skin in the past year –Visible flexural eczema (or eczema affecting the cheeks or forehead and outer limbs in children under 4 years) –Onset in the first two years of life »Children with atopic dermatitis who at the Screening Visit (Visit 1) and at Visit 2 exhibit a score using the SCORAD scoring system for atopic dermatitis of =25 [2] »Children of parents, one of whom gives signed, informed consent to participate in the trial. At entry to double blind period »Children who, according to the European Task Force on Atopic Dermatitis [2] have a SCORAD score of =25 and scores for overall skin condition of 2 on at least 4 days of the 14 days of the baseline. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: »Children with any chronic disease other than associated allergic diseases,( which include recurrent wheezing, allergic rhinitis and food allergy). »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. »Patients who have received oral corticosteroids or corticosteroids by injection within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy, steroid-sparing properties, safety and acceptability of a topically applied new lotion formulation of sodium cromoglicate in the treatment of atopic dermatitis in children.;Secondary Objective: ; Primary end point(s): »Change in SCORAD assessment scores »Change in overall skin condition, itching and sleep disturbance as recorded on the diary cards »Change in use of concomitant topical corticosteroids »Change in Children’s Dermatology Life Quality Index (CDLQI) or Infant Life Quality Index »Acceptability of treatment »Incidence of adverse events | — |
Countries
United Kingdom
Outcome results
None listed