Plain English Summary
Background and study aims
Gynoid lipodystrophy, also known as cellulite, is a very common skin alteration (such as dimples or bumpy) that is mainly a cosmetic concern rather than a real disease. For many people it is very concerning as they do not like the way it looks. Cellulite can be treated through lasers, liposuction (surgical procedure that removes fat) as well as topic treatments (such as creams). However, an effective treatment of cellulite has not been well established. The aim of this study is to evaluate the effect of an anti-cellulite cream on the appearance of cellulite on the thigh.
Who can participate?
Women aged 18 to 65 who have cellulite.
What does the study involve?
Participants are asked to apply a cream once daily for 60 days in the body area affect by cellulite (gluteal regions, thighs and buttock). Participants attend study visits one and two months after using the cream to measure their thigh circumference and have pictures taken of certain areas to assess their cellulite levels.
What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.
Where is the study run from?
This study is being run by Difa Cooper (Italy) and takes place in Medica Plus Modena Via Bernini Coordinator Centre (Italy) and private dermatology services in Naples (Italy)
When is the study starting and how long is it expected to run for?
September 2016 to June 2017
Who is funding the study?
Difa Cooper (Italy)
Who is the main contact?
Dr Massimo Milani
Trial website
Contact information
Type
Scientific
Primary contact
Dr Massimo Milani
ORCID ID
http://orcid.org/0000-0001-7559-1202
Contact details
Difa Cooper
Via Milano 160
Caronno Perusella
21042
Italy
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Efficacy of a novel hypertonic draining cream for cellulite reduction: a Clinical and instrumental (Antera 3D) assessment
Acronym
Study hypothesis
The aim of this study is to evaluate the effect of an anticellulite cream on thigh circumference and skin profilometry assessed by Antera 3D.
Ethics approval
Medica Plus Service Modena, 20/10/2016
Study design
Interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Gynoid lipodystrophy (Cellulite)
Intervention
Participants are given an hypertonic topical product with draining action (HTC cream) that contains NaCl 13%, escine, caffeine and beta-sytosterol. They are asked to apply it once daily on their thighs, gluteal and buttock regions for 60 days.
Participants are assessed at baseline, one and two months to measure their thighs (this procedure is done by an evaluator (office clinic nurses) blinded to the type of treatment. Measurements are done with the participant standing and measuruing up to 25 cm from the superior pole of the patella.
Participant also undergo computer analysis of their skin to asses their cellulite levels at baseline and two months. The Antera 3D CS images system measures in an objective and operator-independent manner the volume of skin protrusions and depressions of a pre-specified area. Volume of depressions in the target zone are expressed in mm3.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Thigh circumferential is measured using a flexible measuring ruler with the participant in standing position and performing the measurement up to 25 cm from the superior pole of the patella at baseline, one and two months
2. Computer-analysis of skin profilometry of a pre-specified target area (in general in the zone above the trochanteric eminence or gluteal zone) evaluated by means of Antera 3D CS (Miravex, Dublin, Ireland) at baseline and two months
Secondary outcome measures
Cellulite (skin appearance) are measured using the orange peel severity score (0 to 5) before and after the pinch test at baseline, one and two months.
Overall trial start date
30/09/2016
Overall trial end date
20/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women aged 18-65 years
2. Have grade II-IV gynoid lipodystrophy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Previous treatment (within 2 months of the study period) for cellulite (topical or oral)
2. Positive history for lower limbs venous or lymphatic insufficiency
3. Pregnancy or breast feeding
4. Positive history of allergic contact dermatitis to any of the component of the cream
Recruitment start date
01/11/2016
Recruitment end date
30/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Medica Plus Modena Via Bernini Coordinator Centre
Modena
-
Italy
Trial participating centre
Private Dermatology Service Naples
Naples
-
Italy
Sponsor information
Organisation
Difa Cooper
Sponsor details
Via Milano 160
Caronno Perusella
21042
Italy
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Difa Cooper SpA
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a Pubmed Indexed international high-impact peer reviewed Journal by the end of October 2017.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Massimo Milani. Data have been stored as Excel file.
Intention to publish date
31/10/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29205802