Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000984099
Ethics application status
Approved
Date submitted
14/11/2010
Date registered
15/11/2010
Date last updated
15/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tea tree oil and iodine in the treatment of molluscum contagiosum in children.
Scientific title
Combination of essential oil of Melaleuca alternifolia and iodine reduces number of visible molluscum contagiosum lesions in children.
Secondary ID [1] 253086 0
None
Universal Trial Number (UTN)
U1111-1117-9166
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Molluscum contagiosum 258650 0
Condition category
Condition code
Skin 258788 258788 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Iodine, tea tree oil, combination of tea tree oil and iodine. Four ul of each treatment applied twice a day to each molluscum lesion for 30 days. Each treatment group received a 4 ul application twice a day. The iodine group received 4 ul of iodine solution only, the tea tree oil group received 4 ul of tea tree oil only, and the combination group received 4 ul of a combination of iodine in tea tree oil delivering the same amount of iodine as the iodine group alone received.
Intervention code [1] 257605 0
Treatment: Other
Comparator / control treatment
tea tree oil vs. iodine vs. combination of tea tree oil + iodine
Control group
Active

Outcomes
Primary outcome [1] 259655 0
Reduction of visible molluscum lesions by 90% or greater at the end of 30 days.
Timepoint [1] 259655 0
30 days
Secondary outcome [1] 266326 0
Nil
Timepoint [1] 266326 0
Nil

Eligibility
Key inclusion criteria
Age: 9 mo to 15 years, otherwise healthy
Gender: Male and Female
Minimum age
9 Months
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Concurrent illness
Any comorbidity

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)
randomization by sealed container
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subject or subject's parent blindly chose a numbered token from an opaque container containing tokens numbered 1-99. Numbers 1-33 assigned to iodine treatment, numbers 34-66 assigend to tea tree oil treatment, numbers 67-99 assigned to tea tree oil + iodine treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3046 0
United States of America
State/province [1] 3046 0
ID

Funding & Sponsors
Funding source category [1] 258054 0
Other Collaborative groups
Name [1] 258054 0
Center for Biomedical Research, Inc.
Country [1] 258054 0
United States of America
Primary sponsor type
Individual
Name
Briant Burke, MD, MS
Address
340 E. Old Saybrook
Boise, Idaho 83706
Country
United States of America
Secondary sponsor category [1] 257248 0
Other Collaborative groups
Name [1] 257248 0
Center for Biomedical Research, Inc.
Address [1] 257248 0
967 E. Parkcenter Blvd
Ste 205
Boise, Idaho 83706
Country [1] 257248 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260054 0
Center for Biomedical Research Ethics Committee
Ethics committee address [1] 260054 0
Ethics committee country [1] 260054 0
United States of America
Date submitted for ethics approval [1] 260054 0
Approval date [1] 260054 0
12/04/2006
Ethics approval number [1] 260054 0
EC-1011-102006

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

Contacts
Principal investigator
Name 31913 0
Address 31913 0
Country 31913 0
Phone 31913 0
Fax 31913 0
Email 31913 0
Contact person for public queries
Name 15160 0
Briant Burke, MD, MS
Address 15160 0
967 E. Parkcenter
Ste 205
Boise, Idaho 83706
Country 15160 0
United States of America
Phone 15160 0
1-800-694-6855
Fax 15160 0
Email 15160 0
[email protected]
Contact person for scientific queries
Name 6088 0
Briant Burke, MD, MS
Address 6088 0
967 E. Parkcenter
Ste 205
Boise, Idaho 83706
Country 6088 0
United States of America
Phone 6088 0
1-800-694-6855
Fax 6088 0
Email 6088 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.