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Trial registered on ANZCTR


Registration number
ACTRN12610001069044
Ethics application status
Approved
Date submitted
1/12/2010
Date registered
6/12/2010
Date last updated
19/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical timolol maleate gel for non-complicated superficial infantile haemangiomas
Scientific title
Topical timolol maleate gel for the reduction in colour and size of non-complicated superficial infantile haemangiomas.
Secondary ID [1] 253222 0
n/a
Universal Trial Number (UTN)
U1111-1118-3598
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infantile haemangioma 258747 0
Condition category
Condition code
Skin 258899 258899 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Timolol maleate gel 0.5% one drop applied to the cutaneous ,small (<5cm), superficial infantile haemangioma twice daily for 24 weeks
Intervention code [1] 257692 0
Treatment: Drugs
Comparator / control treatment
Emollient lubricant eye drop one drop applied to the cutaneous small (<5cm), superficial infantile haemangioma twice daily for 24 weeks. Placebo chosen as drops feel the same as the active gel.
Control group
Placebo

Outcomes
Primary outcome [1] 259759 0
decrease in red colour scored 0,1,2 both clinically and from photographs
Timepoint [1] 259759 0
1 week,2 weeks,4 weeks,8weeks,12 weeks,16 weeks,20 weeks,24 weeks
Secondary outcome [1] 268520 0
heart rate - with a stethescope measure beats per minute
Timepoint [1] 268520 0
1 week,2 weeks,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,24 weeks
Secondary outcome [2] 268521 0
blood pressure- with a sphygmomanometer
Timepoint [2] 268521 0
1 week,2 weeks,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,24 weeks

Eligibility
Key inclusion criteria
infantile haemangiomas <5 cm
Minimum age
5 Weeks
Maximum age
24 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
PHACE syndrome
lesions >5cm diametre
deep subcutaneous lesions
<5 weeks old
>24 weeks old

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)
randomisation using adaptive allocation of minimisation to ensure randomisation of subgroups 5-14 weeks and 15-24 weeks. allocation concealment with randomisation will be carried out by the pharmacist with the assistance of the statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
pharmacist will phone the statistician with the subgroup age 5-14 weeks versus 15-24 weeks to ensure stratified allocation and the allocation will be generated using permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 258165 0
Charities/Societies/Foundations
Name [1] 258165 0
Sydney children's Hospital foundation
Address [1] 258165 0
High st
Randwick
NSW 2031
Country [1] 258165 0
Australia
Primary sponsor type
Hospital
Name
Sydney Children's Hospital
Address
High St
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 257339 0
None
Name [1] 257339 0
Address [1] 257339 0
Country [1] 257339 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260153 0
SESI NSW Health Northern Hospital network
Ethics committee address [1] 260153 0
edmund Blacket Building
The prince of wales Hospital
Cnr High and Avoca Sts
Randwick
NSW2031
Ethics committee country [1] 260153 0
Australia
Date submitted for ethics approval [1] 260153 0
Approval date [1] 260153 0
23/11/2010
Ethics approval number [1] 260153 0
1/10/0116

Summary
Brief summary
Non-complicated infantile haemangiomas have been followed up with minimal intervention because of spontaneous involution. However the involution phase is slow and most children go to school with a disfiguring infantile haemangioma. Propranolol has been observed to accelerate the involution phase and a small retrospective chart review and a single case report have suggested that topical timolol maleate gel 0.5% may reduce the proliferative phase of smal and superficial infantile haemangiomas with reduced systemic complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31979 0
Address 31979 0
Country 31979 0
Phone 31979 0
Fax 31979 0
Email 31979 0
Contact person for public queries
Name 15226 0
Orli Wargon
Address 15226 0
Department of Paediatric dermatology
High st
Randwick
NSW 2031
Country 15226 0
Australia
Phone 15226 0
+61 2 93821776
Fax 15226 0
+61 2 93821787
Email 15226 0
fenella.brisley@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 6154 0
as above
Address 6154 0
as above
Country 6154 0
Australia
Phone 6154 0
as above
Fax 6154 0
as above
Email 6154 0
orli.wargon@sesiahs.health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary