Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000438055
Ethics application status
Approved
Date submitted
6/05/2010
Date registered
28/05/2010
Date last updated
12/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 251688 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
rHußD2-AD-001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 257297 0
Condition category
Condition code
Skin 257447 257447 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256430 0
Treatment: Drugs
Comparator / control treatment
Placebo is made of the same cream composition but without the active ingrediant
Control group
Placebo

Outcomes
Primary outcome [1] 258366 0
To establish the safety and tolerability of the rHuB[beta]D2 cream in comparison to the placebo cream.
Timepoint [1] 258366 0
All treatment sites will be assessed by the study doctor at each clinic visit and patient asked to provide responses to tolerability questions. For Stage 1 and 2 this will be every day for the duration of the stage. For Stage 3 this will be approximately every second day for 14 days.
Primary outcome [2] 258367 0
To compare the change in the local dermatitis score SCORing Atopic Dermatitis (SCORAD) at the treatment sites of the rHuB[beta]D2 cream and the placebo cream between the start of treatment (day 0) and the end of treatment (day 14). SCORAD efficacy assessed at Stage 3 approximately every second day
Timepoint [2] 258367 0
SCORing Atopic Dermatitis (SCORAD)of intensity items will be taken at each timepoint for each treatment site
Primary outcome [3] 258368 0
To assess the change in the Staphylococcus aureus colonization rate at the treatment sites between the start of treatment (day 0) and the end of treatment (day 14).
Timepoint [3] 258368 0
For Stage 3, a bacterial swab of the affected area will be taken at baseline and Day 14 to test for Staphylococcus aureus.
Secondary outcome [1] 264099 0
To assess the change in the colonization rate of any bacteria at the treatment sites between the start of treatment (day 0) and the end of treatment (day 14).
Timepoint [1] 264099 0
For Stage 3, a bacterial swab of the affected area will be taken to test for Staphylococcus aureus.
Secondary outcome [2] 264100 0
To compare the symptomatic relief of the rHuB[beta]D2 cream and the placebo cream as assessed by the patient using a Likert scale.
Timepoint [2] 264100 0
Patients will perform a 5-point scale to assess the symptomatic relief of all treatment sites at all timepoints.

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2874 0
4066

Funding & Sponsors
Funding source category [1] 256919 0
Commercial sector/Industry
Name [1] 256919 0
Planton GmbH
Country [1] 256919 0
Germany
Primary sponsor type
Commercial sector/Industry
Name
Planton GmbH
Address
Am-Kiel-Kanal 44, 24106 Kiel)
Country
Germany
Secondary sponsor category [1] 256188 0
Commercial sector/Industry
Name [1] 256188 0
Clinical Network Services Pty Ltd
Address [1] 256188 0
Level 4, 88 Jephson St, Toowong, Queensland, 4066
Country [1] 256188 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258925 0
Bellberry Limited
Ethics committee address [1] 258925 0
Ethics committee country [1] 258925 0
Australia
Date submitted for ethics approval [1] 258925 0
Approval date [1] 258925 0
22/12/2009
Ethics approval number [1] 258925 0
A204/09]

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31131 0
Address 31131 0
Country 31131 0
Phone 31131 0
Fax 31131 0
Email 31131 0
Contact person for public queries
Name 14378 0
Project Manager
Address 14378 0
Level 4 88 Jephson Street, Toowong Brisbane QLD 4066.
Country 14378 0
Australia
Phone 14378 0
+61 7 3719 6000
Fax 14378 0
+61 7 3719 6011
Email 14378 0
[email protected]
Contact person for scientific queries
Name 5306 0
Project Manager
Address 5306 0
Level 4 88 Jephson Street, Toowong Brisbane QLD 4066.
Country 5306 0
Australia
Phone 5306 0
+61 7 3719 6000
Fax 5306 0
+61 7 3719 6011
Email 5306 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInterventions to reduce staphylococcus aureus in the management of eczema.2019https://dx.doi.org/10.1002/14651858.CD003871.pub3
N.B. These documents automatically identified may not have been verified by the study sponsor.