Condition category
Skin and Connective Tissue Diseases
Date applied
10/07/2017
Date assigned
13/07/2017
Last edited
24/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

www.difacooper.com

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 current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/10/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/10/2017: Internal review 25/09/2017: Internal review