Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000668909
Ethics application status
Approved
Date submitted
30/06/2011
Date registered
1/07/2011
Date last updated
6/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of micro-needling skin therapy for recessive dystrophic epidermolysis bullosa (RDEB) in Australia
Scientific title
Investigation of micro-needling skin therapy for recessive dystrophic epidermolysis bullosa (RDEB) in Australia to assess median healing time of lesions
Secondary ID [1] 262536 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
[Recessive dystrophic epidermolysis bullosa] 268204 0
Condition category
Condition code
Skin 268333 268333 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
micro-needling is a procedure used to stimulate collagen synthesis. It consists of a handheld device with protruding fine needles which pentrate the skin inducing regeneration. Selected wounds will have the microneedling device. This occurs once during the study at baseline. Similar symmetrical wounds will be chosen. One of the pair will be randomised to have the active treatment (microneedling), the other will have the placebo (microneedling device without needles). This will occur at baseline and then both wounds will be measured to determine which heals faster. This is not a cross-over trial.
Intervention code [1] 266879 0
Treatment: Devices
Comparator / control treatment
microneedling device without needles
Control group
Placebo

Outcomes
Primary outcome [1] 269102 0
median healing time of lesions for each treatment group- assessed by the Visitrak machine
Timepoint [1] 269102 0
assessed at regular time intervals and at 12 months.
Secondary outcome [1] 276933 0
Percent change in size of wounds for each treatment group- assessed by the Visitrak machine
Timepoint [1] 276933 0
assessed at regular time intervals and at 12 months.
Secondary outcome [2] 276934 0
Change in appearance score (VAS) of wounds for each treatment group as assessed by investigator and patient
Timepoint [2] 276934 0
assessed at regular time intervals and at 12 months.
Secondary outcome [3] 276935 0
Change in pain score (VAS) of wounds for each treatment group
Timepoint [3] 276935 0
assessed at regular time intervals and at 12 months
Secondary outcome [4] 276936 0
Change in pruritus score (VAS) of wounds for each treatment group
Timepoint [4] 276936 0
assessed at regular time intervals and at 12 months

Eligibility
Key inclusion criteria
Diagnosis of RDEB-HS (patients should have detectable low levels of collagen VII expression and reduced / abnormal anchoring fibrils on electron microscopy).
At least 2 symmetric wounds on each side of the body (arms, chest/abdomen, legs) of approximately the same size (at least 4 cm2 as measured accurately by the Visitrak wound measurement system [Smith & Nephew Healthcare Ltd., Hull], difference should not be more than 15%).
Ability to sign informed consent, which indicates the investigational nature of this study.
Age greater than or equal to 18.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical evidence of local infection of the targeted wound(s).
Histopathologic evidence of malignancy (i.e. squamous cell carcinoma - SCC) of the targeted wound(s).
Use of systemic or topical steroid therapy within 30 days before enrolment.
Use of any investigational drug within the 30 days before enrolment.
Patients considered by the investigators to be unreliable or have poor compliance
Patients who are pregnant, or who suspect they may be pregnant at the time of the study and lactating women. Women of childbearing age should use effective contraception.

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)
Patients with a diagnosis of RDEB-HS will be recruited for the study. This study will be offered to patients who fulfil the inclusion criteria regardless of gender, race or ethnicity. For each enrolled patient, two to eight symmetric wounds on each side of the body (arms, chest/abdomen, legs) of approximately the same size (at least 4 cm2 as measured accurately by the Visitrak wound measurement system [Smith & Nephew Healthcare Ltd., Hull], difference should not be more than 15%) will be identified by a study dermatologist. These symmetrical wounds will be randomised to either treatment or placebo. 'Allocation is not concealed'
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
the clinical trials pharmacist will use randomisation codes to determine the randomisation process and sequence for the wounds as to which receives treatment or placebo.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
single group of patients, receiving both the active treatment and placebo
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267355 0
Self funded/Unfunded
Name [1] 267355 0
Premier Dermatology
Country [1] 267355 0
Australia
Primary sponsor type
Individual
Name
Professor Dedee Murrell
Address
17 Kensington Street
Kogarah 2217
NSW
Country
Australia
Secondary sponsor category [1] 266421 0
None
Name [1] 266421 0
Address [1] 266421 0
Country [1] 266421 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269330 0
South Eastern Sydney and Illawarra Area Health Service Human Research Ethics Committee- Central network
Ethics committee address [1] 269330 0
Ethics committee country [1] 269330 0
Australia
Date submitted for ethics approval [1] 269330 0
Approval date [1] 269330 0
23/09/2010
Ethics approval number [1] 269330 0
HREC/10/STG/84

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

Contacts
Principal investigator
Name 32817 0
Address 32817 0
Country 32817 0
Phone 32817 0
Fax 32817 0
Email 32817 0
Contact person for public queries
Name 16064 0
Dr Benjamin Daniel
Address 16064 0
Level 0
James Laws House
St George Hospital
Gray Street
Kogarah NSW 2217
Country 16064 0
Australia
Phone 16064 0
+61291132543
Fax 16064 0
+61291132906
Email 16064 0
[email protected]
Contact person for scientific queries
Name 6992 0
Prof Dedee Murrell
Address 6992 0
Level 0
James Laws House
St George Hospital
Gray Street
Kogarah NSW 2217
Country 6992 0
Australia
Phone 6992 0
+61291132543
Fax 6992 0
+61291132906
Email 6992 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
No additional documents have been identified.