Trial Review

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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
Sex
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
1/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
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
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
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
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 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.