DEC-NET Serial number GB408 |
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Published online | 24/05/2005 17.21.00 |
Last updated | 01/08/2005 13.07.47 |
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This trial has been approved by an ethics committee |
Current trial status | Open (actively recruiting new participants) |
Target N. of subjects
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N/A
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Major Disease (ICD9 class) | Contact dermatitis and other eczema |
Experimental drug |
Derma Cal Plus, herbal skin cream
Treatment regimen (dosage and duration) Topical application |
Gender | Both |
Age (range) | 2 months to 5 years |
Eligibility criteria |
Inclusion criteria |
Children with mild or moderate atopic eczema within the past month
Children whose parents give informed consent |
Exclusion criteria |
Children whose parents refuse consent
Children with no recent history of a flair up of atopic eczema |
Trial design/methodology |
Phase | 2 |
Kind of study | Efficacy Bioequivalence
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Design | Controlled Randomised Blinded Double blind
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Purpose of study |
A double blind randomised placebo controlled trial to examine the effectiveness of 'Derma Cal Plus cream' in the treatment of children with mild to moderate atopic eczema. |
Primary outcomes |
Reduction in severity of atopic eczema and reduction of frequency of flair ups as reported by parents in questionnaire |
Secondary outcomes |
Reduction in signs and symptoms of atopic eczema, such as reduced discomfort, reduced stratching etc as reported by parents during monthly questionaire. |
Summary of study design, objectives, and ongoing research findings |
A double blind randomized placebo controlled trial to investigate the therapeutic properties of Derma Cal Plus, a herbal skin cream, in the treatment of eczema |