Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001547134
Ethics application status
Approved
Date submitted
28/06/2019
Date registered
11/11/2019
Date last updated
6/05/2021
Date data sharing statement initially provided
11/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of a new caffeine cream on cellulite appearance
Scientific title
Investigation of a new caffeine cream on cellulite appearance in healthy adult volunteers
Secondary ID [1] 298626 0
none
Universal Trial Number (UTN)
U1111-1236-1335
Trial acronym
none
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
cellulite 313495 0
Condition category
Condition code
Skin 311915 311915 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) The cream is to be applied twice a day (morning and night).
b) On each application: rub approx 2g cream on each thigh for 30 sec - the amount will be demonstrated on a spatula
c) Repeat the application each day for a total duration of 12 weeks. A diary is provided for recording each application.
d) At completion of the study (12 weeks) the diary and cream jars will be collected
Intervention code [1] 314886 0
Treatment: Drugs
Comparator / control treatment
Same cream base containing no caffeine
Control group
Placebo

Outcomes
Primary outcome [1] 320584 0
Standardized cellulite photographs and scoring
The participant will put on a thong supplied for the measurement process. The participant will then stand with feet placed on a marked position on the floor. A standardised series of photographs will be taken using a digital SLR camera and light source placed on a tripod at a predetermined height and distance from the treatment site. Images will be coded and stored for later data analysis. Images will be analysed by visual grading by three blinded, independent assessors, who will grade the cellulite based on an established Cellulite Severity Scale. The assessors will be trained using a set of standardised images and their reliability will be assessed by repeat measurement at a 4 week interval. We will train 4 assessors and select the three most reliable for the research study.
Timepoint [1] 320584 0
1. Final assessment will be 12 weeks post first treatment
2. Assessment every 4 weeks post first treatment
Primary outcome [2] 321420 0
Questionnaire
On week 4, 8 and 12 the participant will complete a questionnaire to assess their perception of the cream products in terms of their effects on their skin.
At week 12, participants will also be asked for the overall perception of the cream products in terms of their effects on their skin.
The questionnaire was designed specifically for this trial and was validated by sending to independent researchers for feedback
Timepoint [2] 321420 0
Assessment at 4, 8 and 12 weeks post first treatment
Primary outcome [3] 321421 0
Cutaneous-fold thickness
The skin fold thickness will be measured at a mid-way point within the treatment site. Each skin-fold measurement will be taken by gripping the skin with the thumb and index finger, 1 cm away from the measurement point, then measuring the skin fold thickness with a plicometer. Triplicate measurements will be conducted by a same blinded assessor.
Timepoint [3] 321421 0
Assessment at 4, 8 and 12 weeks post first treatment
Secondary outcome [1] 372110 0
Thigh circumference
The thigh circumference will be measured at a distance (150 mm proximal to the patella), which will be a mid-way point in the treatment site, using a cloth measuring tape. Triplicate measurements will be conducted by an assessor (TP).
Timepoint [1] 372110 0
Assessment at 4, 8 and 12 weeks post first treatment

Eligibility
Key inclusion criteria
We are recruiting only female participants with cellulite present on thighs
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
cellulite treatment in previous 3 months, scarring or surgery at treatment site in previous 12 months

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by computer to generate random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Caffeine. cream or placebo cream assigned to each thigh in randomised design - blinded as to which cream is applied to which thigh
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Number of participants based on our in vitro data of caffeine skin permeation and previous cellulite intervention studies published in the literature.
Analysis of variance will be used to evaluate differences in cellulite between the formulations over time. Any adverse events will be recorded and summarised.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/08/2019
Date of last participant enrolment
Anticipated
Actual
16/09/2019
Date of last data collection
Anticipated
31/01/2020
Actual
31/01/2020
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 26925 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 303167 0
University
Name [1] 303167 0
Curtin University
Country [1] 303167 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth, WA 6845
Country
Australia
Secondary sponsor category [1] 303171 0
None
Name [1] 303171 0
Address [1] 303171 0
Country [1] 303171 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303728 0
Curtin University Human Research Ethics committee
Ethics committee address [1] 303728 0
Ethics committee country [1] 303728 0
Australia
Date submitted for ethics approval [1] 303728 0
28/06/2019
Approval date [1] 303728 0
14/08/2019
Ethics approval number [1] 303728 0
HRE2019-0521

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

Contacts
Principal investigator
Name 94594 0
A/Prof Heather Benson
Address 94594 0
School of Pharmacy and Biomedical Sciences
Curtin University
GPO Box U1987, Perth, WA 6845
Country 94594 0
Australia
Phone 94594 0
+61 8 92662338
Fax 94594 0
+61 8 9266 2768
Email 94594 0
[email protected]
Contact person for public queries
Name 94595 0
Thellie Ponto
Address 94595 0
School of Pharmacy and Biomedical Sciences
Curtin University
GPO Box U1987, Perth, WA 6845
Country 94595 0
Australia
Phone 94595 0
+61 8 92661357
Fax 94595 0
+61 8 9266 2768
Email 94595 0
[email protected]
Contact person for scientific queries
Name 94596 0
Thellie Ponto
Address 94596 0
School of Pharmacy and Biomedical Sciences
Curtin University
GPO Box U1987, Perth, WA 6845
Country 94596 0
Australia
Phone 94596 0
+61 8 92661357
Fax 94596 0
+61 8 9266 2768
Email 94596 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2636Study protocol    377884-(Uploaded-28-06-2019-12-38-12)-Study-related document.docx
2637Informed consent form    377884-(Uploaded-28-06-2019-12-38-50)-Study-related document.docx



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.