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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000237684

Enrollment

120

Registered

2005-08-26

Start date

2003-10-07

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

5 Years to 18 Years

Healthy volunteers

Inclusion criteria

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.

Exclusion criteria

No exclusion criteria

Outcome results