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Trial registered on ANZCTR


Registration number
ACTRN12614000196640
Ethics application status
Approved
Date submitted
18/02/2014
Date registered
24/02/2014
Date last updated
3/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the efficacy of intradermal onabotulinumtoxinA for the treatment of accordion (cheek) wrinkles: A 2-centre randomized double-blinded split face clinical trial
Scientific title
Evaluation of the efficacy of intradermal onabotulinumtoxinA for the treatment of accordion wrinkles: A 2-centre randomized double-blinded split face clinical trial
Secondary ID [1] 284122 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presence of accordion (cheek) wrinkles 291201 0
Condition category
Condition code
Skin 291538 291538 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Selected patient will have bilateral accordion (cheek) wrinkles and will be randomized to receive 20 units of intradermal onabotulinumtoxin A injection on one side of the face and placebo (equal volume of intradermal normal saline injection) on the contralateral face. Patient will be monitored at 2, 4, 8, 12, and 16 weeks post injection for improvement of accordion wrinkles based on serial photographs assessed by the investigator who is blinded and also changes to the skin elasticity measured by a skin cutometer.
Intervention code [1] 288813 0
Treatment: Drugs
Comparator / control treatment
The contralateral side of the face will serve as control with a placebo where equal volume of normal saline is injected intradermally.
Control group
Placebo

Outcomes
Primary outcome [1] 291504 0
Improvement of accordion wrinkles graded on a 0 to 4 scale based on serial photographs taken at week 0, 2, 4, 8, 12, 16. This is assessed by the investigator who is blinded.
Timepoint [1] 291504 0
Week 0, 2, 4, 8, 12, 16.
Secondary outcome [1] 306915 0
Improvement in skin elasticity measured by a cutometer at week 0, 2, 4, 8, 12, 16.
Timepoint [1] 306915 0
Week 0, 2, 4, 8, 12, 16.
Secondary outcome [2] 306916 0
Patient's satisfaction score based on a scale of 1 to 10 at week 2, 4, 8, 12, 16.
Timepoint [2] 306916 0
Week 2, 4, 8, 12, 16.

Eligibility
Key inclusion criteria
1. All male and female patients between ages of 40 - 75 complaining of accordion wrinkles and keen for intervention only for the accordion wrinkles.
2. Accordion wrinkles of at least grade 1 at rest and/or on extreme smile.
3. Of sound mind and able to give consent.
4. Able to be followed up for duration of study.
5. Patients can have been their crow’s feet or squint lines treated anytime prior to start of trial. (Different sets of muscles involved and the location of our injections is of adequate distance from squint lines hence will not affect the outcome)
6. Patients that are on ASA 81mg must be off for 2 weeks.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Females who are pregnant or breast-feeding.
2. Patients who have previous botulinum toxin A injections at the cheek area.
3. Patients who have previous allergy to botulinum toxin A.
4. Patients with previous ablative laser procedures in the cheek area.
5. Patients with non-ablative laser treatment in cheek area in the last 6 months.
6. Patients with incisional surgery in the cheek area.
7. Patients who have muscular or neurological diseases such as amyotrophic lateral sclerosis, myasthenia gravis, Lambert-Eaton Syndrome, etc.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/02/2014
Actual
24/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 5840 0
Canada
State/province [1] 5840 0
Ontario

Funding & Sponsors
Funding source category [1] 288751 0
Commercial sector/Industry
Name [1] 288751 0
Investigator-initiated trial grant from Allergan Inc.
Country [1] 288751 0
Canada
Primary sponsor type
Individual
Name
David Ellis
Address
Art of Facial Surgery, University of Toronto
167 Sheppard Ave West, Toronto, Ontario, Canada
M2N 1M9
Country
Canada
Secondary sponsor category [1] 287447 0
None
Name [1] 287447 0
Address [1] 287447 0
Country [1] 287447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290591 0
Institutional Review Board Services
Ethics committee address [1] 290591 0
Ethics committee country [1] 290591 0
Canada
Date submitted for ethics approval [1] 290591 0
Approval date [1] 290591 0
10/12/2013
Ethics approval number [1] 290591 0

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

Contacts
Principal investigator
Name 46334 0
Prof David Ellis
Address 46334 0
Art of Facial Surgery, University of Toronto
167 Sheppard Ave West, Toronto, Ontario, Canada
M2N 1M9
Country 46334 0
Canada
Phone 46334 0
1-416-2291050
Fax 46334 0
Email 46334 0
ellis2106@gmail.com
Contact person for public queries
Name 46335 0
Tee Sin Lee
Address 46335 0
Art of Facial Surgery, University of Toronto
167 Sheppard Ave West, Toronto, Ontario, Canada
M2N 1M9
Country 46335 0
Canada
Phone 46335 0
1-647-471-1682
Fax 46335 0
Email 46335 0
leeteesin@gmail.com
Contact person for scientific queries
Name 46336 0
Tee Sin Lee
Address 46336 0
Art of Facial Surgery, University of Toronto
167 Sheppard Ave West, Toronto, Ontario, Canada
M2N 1M9
Country 46336 0
Canada
Phone 46336 0
1-647-471-1682
Fax 46336 0
Email 46336 0
leeteesin@gmail.com

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.