Children aged 1-15 years with Atopic Dermatitis
Conditions
Interventions
Trade Name: Elocon ointment
Product Name: Elocon ointment
Product Code: Elocon ointment
Pharmaceutical Form: Ointment
Sponsors
Princess Alexandra Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The children should have AD as defined above. They should have small active patches, requiring treatment with topical corticosteroids on both sides of the body. 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 dermatitis covering an area larger than the occlusive dressing will be excluded. Children with known sensitivities to the study treatments, evidence of infected or bleeding AD or AD that is confined to the face or napkin area will also be excluded. Children who had received either oral steroid treatment, applied topical steroids to the study area or used alternative remedies will be excluded (16). Children less than one year old will be excluded as more potent corticosteroids are contraindicated for children less than one year (5).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is to see whether covering discrete patches of atopic dermatitis with op site occlusive dressing results in a more rapid resolution in the patches of atopic dermatitis without causing an increase in side effects such as redness, itching and irritation. The primary outcome measure will be the three item severity score (TIS) measured at each hospital visit. This is based on the evaluation of erythema, oedema/papulation and excoriation each on a scale of 0-3 (0=absent, 1=mild, 2=moderate and 3=severe). Therefore, the range of TIS therefore lies between 0 and 9. Scores from 1-3 will be categorised as mild, 4-6 as moderate and 7-9 as severe. If the score is zero then there is no detectable lesion. The TIS score will be measured on days one, four and eight. The differences between the scores in both arms of the trial at the different stages will be analysed. ;Secondary Objective: Secondary Outcomes The size of the patch (maximum width and length) will be recorded at each clinic visit. Parents will be asked to record any side effects or problems they have faced and inform us after the final assessment. The families will also be asked about compliance with instructions. The lesions on both sides will be photographed with a scale marker. ;Primary end point(s): The children will apply the steriod cream and occlusion for 3 days only they will then be reviewed on day 4 and day 8, they will then be seen at their routine outpatient appointments. | — |
Countries
United Kingdom
Outcome results
None listed