DEC-NET Serial number GB404 |
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Published online | 23/05/2005 13.56.00 |
Last updated | 06/03/2006 17.40.59 |
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Other protocol ID number | N0405128530 |
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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75
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Major Disease (ICD9 class) | Atopic dermatitis and related conditions |
Experimental drug |
Wet wrap therapy
Treatment regimen (dosage and duration) group 1 receive 2 weeks WWT with Tubifast and once daily 1% hydrocortisone
Group 2 -2 weeks of twice daily 1% hydrocortisone without WWT
group 3 2 weeks of emollients and WWT without 1% hydrocortisone
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Control drug |
HYDROCORTISONE
Treatment regimen (dosage and duration) group 1 receive 2 weeks WWT with Tubifast and once daily 1% hydrocortisone
Group 2 -2 weeks of twice daily 1% hydrocortisone without WWT
group 3 2 weeks of emollients and WWT without 1% hydrocortisone
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Gender | Both |
Age (range) | under 5 years |
Eligibility criteria |
Inclusion criteria |
suffering from atopic dermatitis |
Exclusion criteria |
children whom will not tolerate 'wet wrap' therapy |
Trial design/methodology |
Phase | 3 |
Kind of study | |
Design | Controlled Randomised
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Purpose of study |
to ascertain whether or not the use of Wet Wrap Therapy (WWT) is more effective than conventional therapy with topical hydrocortisone in the treatment of atopic dermatitis in preschool children. |
Primary outcomes |
To ascertain whether or not the use of Wet Wrap Therapy is more effective than conventional therapy with topical hydrocortisone. |
Secondary outcomes |
Reduction in signs and symptoms |
Summary of study design, objectives, and ongoing research findings |
An observational randomised controlled trial; to compare the cost effectiveness of using wet wrap therapy and topical hydrocrizone in the treatment of atopic dermatitis in children under the age of 5 years.
Children will be randomised into one of three groups - group 1 receive 2 weeks WWT with Tubifast and once daily 1% hydrocortisone
Group 2 - 2 weeks of twice daily 1% hydrocortisone without WWT
group 3 - 2 weeks of emollients and WWT without 1% hydrocortisone
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