A long term, non-comparative study to evaluate the safety and efficacy of an ointment in paediatric patients
DEC-NET Serial number GB254
Published online24/06/2004 13.11.00
Last updated22/11/2005 9.58.03
Other protocol ID numberN0012128234
This trial has been approved by an ethics committee
Current trial statusOpen (actively recruiting new participants)
Major Disease
(ICD9 class)		OTHER ATOPIC DERMATITIS
Experimental drug
0.03% of ointment
GenderBoth
Age (range)2-18

Eligibility criteria
Inclusion criteria
Paediatric patients with atopic dermatitis Informed consent from parents and if appropriate the childen
Exclusion criteria
Children outside the above inclusion criteria Children who will not conform to regime

Trial design/methodology
Phase2
Kind of studyEfficacy
Safety
DesignControlled
Randomised
Blinded
Single blind
Purpose of study
To assess the safety and efficacy of 0.03% of ointment as long term treatment in paediatric patients with atopic dermatitis
Primary outcomes
Safety of ointment
Secondary outcomes
efficacy of ointment
Summary of study design, objectives, and ongoing research findings
Randomised controlled trial; Random allocation (A) treatment for atopic dermatitis (B) Placebo.
Principal investigator
NameProf J Harper
InstitutionGreat Ormond Street Hospital
Postal addressDermatology, Great Ormond Street Hospital, Great Ormond Street, London, WC1N 3JH
CityLondon
CountryUNITED KINGDOM
Phone020 7405 9200
Fax
E-mailHarpeJ@gosh.nhs.uk


Sponsor name
(Commercial Funder) (Industry)

ISRCTN  EudraCT