ANZCTR - Registration

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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]

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

Condition category

Condition code

Skin

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]

Treatment: Drugs

Comparator / control treatment

Same cream base containing no caffeine

Control group

Placebo

Outcomes

Primary outcome [1]

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]

1. Final assessment will be 12 weeks post first treatment
2. Assessment every 4 weeks post first treatment

Primary outcome [2]

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]

Assessment at 4, 8 and 12 weeks post first treatment

Primary outcome [3]

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]

Assessment at 4, 8 and 12 weeks post first treatment

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6102 - Bentley

Funding & Sponsors

Funding source category [1]

University

Name [1]

Curtin University

Address [1]

GPO Box U1987
Perth, WA 6845

Country [1]

Australia

Primary sponsor type

University

Name

Curtin University

Address

GPO Box U1987
Perth, WA 6845

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics committee

Ethics committee address [1]

Curtin University
GPO Box U1987
Perth, WA 6845

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/06/2019

Approval date [1]

14/08/2019

Ethics approval number [1]

HRE2019-0521

Summary

Brief summary

Cellulite is as an "orange peel" appearance on the skin surface that is associated with poor microcirculation, weight change, race and heredity, but there is little consensus about its cause. The objective of this study is to determine the effect of a caffeine cream that we have developed on cellulite appearance, thigh circumference and skin fold thickness. We will also assess participants' perception of the sensorial qualities of the caffeine cream. Participants will apply the cream to one thigh and a placebo cream to the other thigh twice daily for 12 weeks. Assessments will be done at week 4, 8 and 12. We anticipate that the developed cream will target caffeine to the skin tissue and reduce cellulite.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Heather Benson

Address

School of Pharmacy and Biomedical Sciences
Curtin University
GPO Box U1987, Perth, WA 6845

Country

Australia

Phone

+61 8 92662338

Fax

+61 8 9266 2768

h.benson@curtin.edu.au

Contact person for public queries

Name

Thellie Ponto

Address

School of Pharmacy and Biomedical Sciences
Curtin University
GPO Box U1987, Perth, WA 6845

Country

Australia

Phone

+61 8 92661357

Fax

+61 8 9266 2768

thellie.ponto@postgrad.curtin.edu.au

Contact person for scientific queries

Name

Thellie Ponto

Address

School of Pharmacy and Biomedical Sciences
Curtin University
GPO Box U1987, Perth, WA 6845

Country

Australia

Phone

+61 8 92661357

Fax

+61 8 9266 2768

thellie.ponto@postgrad.curtin.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2636	Study protocol					377884-(Uploaded-28-06-2019-12-38-12)-Study-related document.docx
2637	Informed 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.

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