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

Childhood eczema

Eligibility

Sex: Both males and femalesMin Age: 5 YearssMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying phase II Study of AVAC (TM) for the Treatment of Atopic Dermatitis in Children. You may be eligible if you are adults aged 5 to 18 who diagnosis of moderate-to-severe atopic dermatitis (AD). Severity defined according to Rajka and Langeland criteria. People with no exclusion criteria may not be able to participate. Participation may involve medical tests, study visits, and follow-up appointments.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

3 intradermal injections of AVAC (TM) at intervals of 2 weeks (Weeks 0, 2 and 4)

Locations(1)

New Zealand

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ACTRN12605000237684