CompletedPhase 2ACTRN12605000237684
Phase II Study of AVAC (TM) for the Treatment of Atopic Dermatitis in Children
A blinded, randomised, placebo-controlled Phase II study to evaluate the safety and efficacy of 12.5 mcg AVAC (TM) (delipidated, deglycolipidated and arabinogalactan depleted derivative of heat-killed Mycobacterium vaccae suspension) in children with moderate-to-severe atopic dermatitis (AD)
Sponsor
Genesis Research & Development Corporation Ltd
Enrollment
120 participants
Start Date
Oct 7, 2003
Study Type
Interventional
Conditions
Eligibility
Sex: Both males and femalesMin Age: 5 YearssMax Age: 18 Yearss
Inclusion Criteria1
- Diagnosis of moderate-to-severe atopic dermatitis (AD). Severity defined according to Rajka and Langeland criteria; atopic dermatitis defined according to UK Atopic Dermatitis Working Party criteria.
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Interventions
3 intradermal injections of AVAC (TM) at intervals of 2 weeks (Weeks 0, 2 and 4)
3 intradermal injections of AVAC (TM) at intervals of 2 weeks (Weeks 0, 2 and 4)
Locations(1)
View Full Details on ANZCTR
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ACTRN12605000237684