A Randomised, Double-blind, Placebo-controlled Phase I Study to Determine the Safety and Efficacy of Recombinant Human B[beta] Defensin 2 (rHuB[beta]D2 cream) in the Treatment of Staphylococcus aureus and other Infections in the Skin of Patients with Atopic Dermatitis

A Randomised, Double-blind, Placebo-controlled Phase I Study to Determine the Safety and Efficacy of Recombinant Human ß Defensin 2 (rHuB[beta]D2 cream) in the Treatment of Staphylococcus aureus and other Infections in the Skin of Patients with Atopic Dermatitis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000438055

Acronym

rHußD2-AD-001

Enrollment

Registered

2010-05-28

Start date

2010-05-07

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

Subjects will be dosed topically with both placebo and active creams (150 micrograms) randomised to either lesional or non-lesional skin. Subjects will be dosed either once, twice a day for 2 days or twice a day for 14 days.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

Currently suffering from atopic dermatitis (AD) with a primary diagnosis of AD at least 12 weeks prior to inclusion into the study. With a SCORAD between 20 and 50 (i.e., mild to moderate AD). Diagnosed with disseminated symmetric dermatitis. Colonisation of lesional skin with Staphylococcus aureus (and probably other micro-organisms)

Exclusion criteria

Current use of the following therapeutic interventions at the affected areas of the skin and a zone of 4 cm around the affected areas: - Any kind of topical glucocorticosteroidproducts - Cyclosporine or other calcineurin inhibitors - Topical antibiotics or antiseptics (also in ointments)

Outcome results