Efficacy of a novel cream with antiedema function in the treatment of cellulite

ISRCTN ISRCTN15111614
DOI https://doi.org/10.1186/ISRCTN15111614
Secondary identifying numbers N/A
Submission date
10/07/2017
Registration date
13/07/2017
Last edited
11/07/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Massimo Milani
Scientific

Difa Cooper
Via Milano 160
Caronno Perusella
21042
Italy

ORCiD logoORCID ID 0000-0001-7559-1202

Study information

Study designInterventional randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEfficacy of a novel hypertonic draining cream for cellulite reduction: a Clinical and instrumental (Antera 3D) assessment
Study objectivesThe 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(s)Medica Plus Service Modena, 20/10/2016
Health condition(s) or problem(s) studiedGynoid lipodystrophy (Cellulite)
InterventionParticipants 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 typeOther
Primary outcome measure1. 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 measuresCellulite (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 study start date30/09/2016
Completion date20/06/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants20
Key inclusion criteria1. Women aged 18-65 years
2. Have grade II-IV gynoid lipodystrophy
Key exclusion criteria1. 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
Date of first enrolment01/11/2016
Date of final enrolment30/03/2017

Locations

Countries of recruitment

  • Italy
  • United Kingdom

Study participating centres

Medica Plus Modena Via Bernini Coordinator Centre
Modena
-
Italy
Private Dermatology Service Naples
Naples
-
Italy

Sponsor information

Difa Cooper
Industry

Via Milano 160
Caronno Perusella
21042
Italy

Website www.difacooper.com
ROR logo "ROR" https://ror.org/044sr7e96

Funders

Funder type

Industry

Difa Cooper SpA

No information available

Results and Publications

Intention to publish date31/10/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a Pubmed Indexed international high-impact peer reviewed Journal by the end of October 2017.
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2018 Yes No

Editorial Notes

11/07/2018: IPD sharing statement added.
10/07/2018: Publication reference added.
24/10/2017: Internal review
25/09/2017: Internal review