Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001208190
Ethics application status
Approved
Date submitted
15/08/2019
Date registered
30/08/2019
Date last updated
7/06/2023
Date data sharing statement initially provided
30/08/2019
Date results provided
7/06/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Open Label Study of Participants with Moderate or Severe Cellulite to Evaluate Focal Contouring.
Scientific title
An Open Label Feasibility Study of Participants with Moderate or Severe Cellulite to Evaluate Focal Contouring.
Secondary ID [1] 299031 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cellulite 314044 0
Condition category
Condition code
Skin 312431 312431 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Focal Contouring system consists of a set of tools to access and release septa associated with cellulite. This new procedure, called Focal Contouring, is being done to determine whether it is safe and may be effective in reducing the appearance of moderate or severe cellulite on the thighs and buttocks. This procedure, lasting approximately 60 - 90 minutes, will be done by a plastic surgeon or surgical dermatologist in their clinic. After local anaesthetic has been applied to the intended area, this experimental procedure/intervention involves a small incision (less than 1cm) in the skin at the intended procedural area of mid-thigh/buttock. The deployable hook is introduced through the skin and then guided to the targeted area with the assistance of the light fibre which will illuminate under the skin. The hook is then hooked around the fibrous septa where tension is then applied to release the fibrous septa. By doing this to areas of cellulite it is hoped that a visual change may occur which could potentially improve the overall impression of cellulite areas. The side to be treated is at the discretion of the treating doctor.
Intervention code [1] 315305 0
Treatment: Devices
Comparator / control treatment
This is a prospective, single-arm, multi center, open-label study conducted in up to 25 participants with moderate or severe cellulite with a maximum follow-up period out to 365 days (1 year). Photography will be performed at designated timepoints.

Group 1 (Site 1): The first 10 participants. Only one side (unilateral) treatment will occur allowing for same-participant comparison of feasibility (a secondary study objective), and participants will be followed through 90 days. At the last visit (90 days) the participant will be offered the option to have the second, contralateral side treated under Group 2. Data will be collected at baseline, during and Days 1, 3, 14, 30 and 90 post procedure.

Group 2 (Site 1) and 3 (Site 2): This group will comprise those participants in Group 1 electing contralateral side treatment, plus up to 15 newly recruited participants. The unilateral thighs/buttocks requirement imposed in Group 1 is no longer required in Group 2 and 3. The Group 2 participants will be followed after the procedure through 1 year. Data will be collected at baseline, during and Days 1, 3, 14, 30 and 90, 180 and 365 post procedure.

Group 3 (Site 2):: The last three participants enrolled in the study under the same eligibility requirements as Group 2, but at a second site. Unlike Group 1 and 2, this group will not have the option for a refinement procedure. The follow-up for this group will be through 6-months. Data will be collected at baseline, during and Days 1, 3, 14, 30 and 90 and 180 post procedure.
Control group
Active

Outcomes
Primary outcome [1] 321080 0
To evaluate the safety of the procedure in participants with moderate or severe cellulite determined by a lack of serious adverse device effects. This includes review of medications required in the post surgery period, Additionally safety assessments will include a review of hematomas, ecchymosis, hemosiderosis, seromas, areas of firmness or softness, erythema, wound drainage, scarring, dyspigmentation, tissue atrophy and contour irregularities.
Timepoint [1] 321080 0
Data will be collected at all participant visits including procedure day and post procedure.

Group 1: The follow-up for this group will be through 3-months. Data will be collected at all participant visits including procedure day and Days 1, 3, 14, 30 and 90 post procedure..

Group 2 and 3 (Site 1): The follow-up for this group will be through 12-months. Data will be collected at all participant visits including procedure day and Days 1, 3, 14, 30, 90, 180 and 365 post procedure.

Group 3 (Site 2): The follow-up for this group will be through 6-months. Data will be collected at all participant visits including procedure day and Days 1, 3, 14, 30, 90 and 180 days post procedure.
Secondary outcome [1] 373916 0
Feasibility (percentage of participants the procedure produces an effect), determined by the percentage of participants having a reduction in the appearance of their cellulite in the procedure area according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent and blinded physician assessment of participant photographs taken procedure day and specified time points until study exit for all Groups. The secondary endpoint will be considered reached if greater than 50% of participants have a reduction in the appearance of their cellulite in the procedure area. Clinical significance will be shown if there is a 1 point or more improvement in GAIS.
Timepoint [1] 373916 0
Data will be collected (photography) on
• Group 1 :Days 3, 14, 30, 90 post procedure
• Group 2 :Days 3, 14, 30, 90, 180 and 365 post procedure
• Group 2 :Days 3, 14, 30, 90 and 180 post procedure
Secondary outcome [2] 422814 0
Participant satisfaction with procedure, their experience and likelihood to recommend the procedure, using a self-assessment questionnaire according to a 5-point Likert type scale.
Timepoint [2] 422814 0
A self-assessed questionnaire will be conducted by the participants at the following timepoints::
• Group 1 :Days 30, 90 post procedure
• Group 2 :Days 30, 90, 180 and 365 post procedure
• Group 3 :Days 30, 90 and 180 post procedure
Secondary outcome [3] 422815 0
Procedure tolerability using a 0-10 numerical rating scale. Participants will be asked to rate and then describe any pain in the procedure area.
Timepoint [3] 422815 0
A self-assessed questionnaire will be conducted by the participants at the following timepoints:
• Group 1 :Baseline, immediately post procedure, and Day 1, 3, 14, 30, 90 post procedure
• Group 2 :Baseline, immediately post procedure, and Days 30, 90, 180 and 365 post procedure
• Group 3 :Baseline, immediately post procedure, and Days 30, 90 and 180 post procedure

Eligibility
Key inclusion criteria
1. Moderate (depressions appear spontaneously when standing and not lying down) or severe (depressions appear spontaneously when standing and lying down) cellulite in the thighs and/or buttocks
2. BMI less than 30
3. Caucasian
4. Fluency in both written and spoken English
5. Negative urine pregnancy test
6. Will not try any other cellulite procedures through the follow-up period
7. Participants of the previously conducted Contour-0001 study will be permitted to be enrolled provided they have exited the Contour-0001 study already.
Minimum age
21 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Contour-0001 or Contour-0002 cellulite procedure on the thighs or buttocks in the last 3 months
2. Any non-Contour System procedure on thighs or buttocks to treat cellulite (for example, Cellfina)
3. Prior liposuction in the thighs or buttocks
4. Greater than 10% increase or decrease in body weight within the last six months or history of greater than 60 kilograms weight loss
5. Evidence of an active infection or fever greater than 38oC
6. Current or recent smoker (within 6 months)
7. History of hypertension, diabetes or hypoglycemia
8. Non-Caucasian
9. Pregnant or breast feeding
10. History of coagulopathy(ies) or pneumopathy
11. History of severe anemia
12. Has atrophic scars, or a history of atrophic scars or keloids
13. Taken within 14 days of procedure:
a. NSAIDs (e.g., aspirin, ibuprofen, naproxen)
b. Vitamin E, herbal teas or dietary supplements (e.g., Gingko Biloba, Willow Bark)
14. Any known factor, condition or disease that in the opinion of the physician might interfere with procedure compliance, study conduct or interpretation of the results such as skin laxity, co-existent psychiatric disease, history of noncompliance to medical regimens, or unwillingness to comply with study requirements

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Single-arm, paired comparison study wherein participants serve as their own control..
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis will be performed on all participants who met all inclusion and none of the exclusion criteria. The study is not powered to make statistically valid comparisons with historical data. All comparisons will be qualitative in nature..

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/08/2019
Date of last participant enrolment
Anticipated
12/09/2019
Actual
17/11/2020
Date of last data collection
Anticipated
31/12/2019
Actual
9/06/2021
Sample size
Target
25
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 27576 0
4215 - Southport
Recruitment postcode(s) [2] 40537 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 303566 0
Commercial sector/Industry
Name [1] 303566 0
Revelle Aesthetics Pty Ltd
Country [1] 303566 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Revelle Aesthetics Pty Ltd
Address
58 Gipps Street, Collingwood VIC 3066
Country
Australia
Secondary sponsor category [1] 303644 0
None
Name [1] 303644 0
Not applicable
Address [1] 303644 0
Not Applicable
Country [1] 303644 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304097 0
Bellberry HREC
Ethics committee address [1] 304097 0
Ethics committee country [1] 304097 0
Australia
Date submitted for ethics approval [1] 304097 0
26/06/2019
Approval date [1] 304097 0
06/08/2019
Ethics approval number [1] 304097 0
2019-06-530

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

Contacts
Principal investigator
Name 95802 0
Dr Craig Layt
Address 95802 0
The Layt Clinic 16 Harvest Court Southport QLD 4215
Country 95802 0
Australia
Phone 95802 0
+61 7 5597 4100
Fax 95802 0
+61 7 5587 6100
Email 95802 0
[email protected]
Contact person for public queries
Name 95803 0
Craig Layt
Address 95803 0
The Layt Clinic 16 Harvest Court Southport QLD 4215
Country 95803 0
Australia
Phone 95803 0
+61 7 5597 4100
Fax 95803 0
+61 7 5587 6100
Email 95803 0
[email protected]
Contact person for scientific queries
Name 95804 0
Rachel Walsh
Address 95804 0
Revelle Aesthetics Pty Ltd, 58 Gipps Street, Collingwood VIC 3066
Country 95804 0
Australia
Phone 95804 0
+61 3 9419 7607
Fax 95804 0
Not Applicable
Email 95804 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be aggregated.


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.