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Trial registered on ANZCTR


Registration number
ACTRN12605000172606
Ethics application status
Approved
Date submitted
16/08/2005
Date registered
18/08/2005
Date last updated
18/08/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing two treatmetns for ulcerated hemagiomas.
Scientific title
Ulcerated hemangiomas treated with amorphous gel as compared with a hydrocolloid will show improved healing rates.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerated hemangiomas 267 0
Condition category
Condition code
Skin 301 301 0 0
Dermatological conditions
Reproductive Health and Childbirth 302 302 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A will receive amorphous gel and Group B will receive a Hydrocolloid
Intervention code [1] 201 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 353 0
Time of healing of the ulcerated hemagioma.
Timepoint [1] 353 0
Primary outcome [2] 354 0
Wheather the ulcer has completly healed.
Timepoint [2] 354 0
Primary outcome [3] 355 0
Percentage of ulcerated area healed.
Timepoint [3] 355 0
Secondary outcome [1] 794 0
Pain assessment by parent of dressing change.
Timepoint [1] 794 0

Eligibility
Key inclusion criteria
Infants with ulcerated hemangioma of infancy between the age of 0-2 years.
Minimum age
0 Years
Maximum age
2 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants who have known hypersensitivity to amorphous gel or a hydrocolloid.Infants with other serious medical conditions requiring therapy.If the ulcerated hemangioma is at a site where dressing cannot be applied.Infants where surgical removal of the ulcer is regarded as the best treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 358 0
Self funded/Unfunded
Name [1] 358 0
Address [1] 358 0
Country [1] 358 0
Primary sponsor type
Hospital
Name
Royal Children's Hospital, Vic, Australia
Address
Country
Australia
Secondary sponsor category [1] 284 0
University
Name [1] 284 0
University of Melbounre, Vic , Australia
Address [1] 284 0
Country [1] 284 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1331 0
Royal Children's Hospital
Ethics committee address [1] 1331 0
Flemington Road Parkville, 3072 VIC
Ethics committee country [1] 1331 0
Australia
Date submitted for ethics approval [1] 1331 0
Approval date [1] 1331 0
Ethics approval number [1] 1331 0

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

Contacts
Principal investigator
Name 35862 0
Address 35862 0
Country 35862 0
Phone 35862 0
Fax 35862 0
Email 35862 0
Contact person for public queries
Name 9390 0
Stella Dohle
Address 9390 0
Royal Children's Hospital
Flemington Road
Parkville VIC 3072
Country 9390 0
Australia
Phone 9390 0
+61 3 93455338 Mobile: +61 407059980
Fax 9390 0
+61 3 93455871
Email 9390 0
stella.dohle@rch.org.au
Contact person for scientific queries
Name 318 0
Stella Dohle
Address 318 0
Royal Children's Hospital
Flemington Road
Parkville VIC 3072
Country 318 0
Australia
Phone 318 0
+61 3 93455338 Mobile: +61 407059980
Fax 318 0
+61 3 93455871
Email 318 0
stella.dohle@rch.org.au

No data has been provided for results reporting
Summary results
Not applicable