Study Aimed at Evaluation of the Effectiveness and Tolerability of an Anti-cellulite Cream Medical Device (DEFBODY)

Sponsored Interventional Single-center Study for the Assessment of the Efficacy and Tolerability of a Medical Device in Crema-gel for the Treatment of PEF (Edemato-fibrosclerotic Panniculopathy of 2nd and 3rd Degree)

Post-marketing clinical study conducted on a CE medical device, named Defense Body, cellulite treatment, edematous fibrosclerotic panniculopathy (2nd and 3rd stage pathology), reducing draining cream-gel, to verify its effectiveness and tolerability on a panel of 56 subjects females affected by 2nd and 3rd degree PEF. The effectiveness of the device is measured in terms of reduction in thigh circumference, improvement in the appearance of the skin with reduction of the orange peel appearance and improvement in skin smoothness.

Study Overview

• Status: Completed
• Conditions: Cellulite
• Intervention / Treatment: Device: Anti-cellulite cream-gel Medical Device (DEFBODY)

Detailed Description

Post-marketing, sponsored, interventional, single-centre clinical study conducted on a medical device, already CE marked, named Defense Body cellulite treatment edematous fibrosclerotic panniculopathy (2nd and 3rd stage pathology) draining reducing gel-cream, to verify the its efficacy and tolerability on a panel of 56 female subjects, aged between 18 and 55, in good general health, and suffering from 2nd and 3rd degree PEF.

A comparison study will be carried out between the clinical condition of the subjects at baseline T0, compared to the condition at the end of treatment T2, with provision for an intermediate visit halfway through treatment, T1.

At the first enrollment visit (T0), the patient will be subjected to anthropometric measurements, measurement of the skin profile of the thigh, measurement of the thigh circumference and evaluation by the clinician of the degree of cellulite using pinch tests and digital photographs of the area. treated in profile and three-quarter view.

After 4 (± 3 days) (T1) and 8 weeks (± 4 days) (T2) from the start of the study, the patient is visited again.

The Doctor will repeat the assessments described at T0, with the addition of verifying continued compliance with the enrollment criteria; overall evaluation by the patient of satisfaction and compliance; recording of each AE or AED or drop-off; recording of any concomitant pharmacological treatment.

The patient's overall assessment of satisfaction and compliance will be carried out only at the last visit.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy
    • Dermatology Unit - I.R.C.C.S. Ospedale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female sex;
• Age between 18 and 55;
• Presence of grade II or III symmetrical cellulite on the right and left lower limbs;
• BMI between 18.5 and 30;
• Good state of health and absence of chronic pathologies;
• Willingness not to change one's lifestyle during study;
• Willingness to join the study and sign the information consent.

Exclusion Criteria:

• Subjects being treated with other topical products in the lower limbs;
• Subjects being treated with other topical or systemic cellulite products;
• Subjects with skin conditions and/or inflammatory conditions underway or had in the period immediately preceding the start of the study;
• Subjects with a history of venous or lymphatic insufficiency in the lower limbs;
• Subjects with known allergies or intolerances to one of the components of the product;
• Pregnant or breastfeeding subjects;
• Subjects undergoing slimming therapy, whether pharmacological or dietary;
• Subjects who practice intense or competitive sporting activity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single arm: 1 bottle (cream-gel) 400ml; Each study subject applies the medical device (one cream-gel of 400ml) on both buttocks and thighs affected by cellulite (II or III degree) massaging with circular movements following the direction of the lymphatic flow, twice a day for 4 weeks ( intermediate visit) and for another 8 weeks (final visit). If the device is finished during the study, a new device may be provided, always one cream-gel of 400 ml.

Device: Anti-cellulite cream-gel Medical Device (DEFBODY); one bottle of 400 ml, twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First day of study initiation: clinical history; personal and demographic data and previous or concomitant treatments	The following activities are planned on the first day: clinical history of the recruited subjects;; personal and demographic data;; previous and/or concomitant treatments.	First day: within 24 hours
First day of study initiation: BMI	Evaluation of height (cm) and weight (Kg) for the calculation of the body mass index, considered in the range 18.5 - 30.	First day: within 24 hours
First day of study initiation: Measurement of waist circumference, hip circumference and thigh circumference	Measurement of: waist circumference;; hip circumference; thigh circumference These measurements are taken using a flexible tape measure with the subject barefoot, in an upright position and, in the specific case of the measurement of the thigh, 1 cm below the crease of the buttock.	First day: within 24 hours
First day of study initiation: digital photographs of the area to be treated	digital photographs of the area to be treated, taken in profile and three-quarter view with a model camera Nikon Digital Camera.	First day: within 24 hours
First day of study initiation: skin profilemetry of the thigh	Evaluation of the skin profilemetry of the thigh in a predetermined target area, through a computerized analysis Antera 3D CS Camera and 3.X software set (Mitavex, Dublin, Ireland). The images obtained allow the operator to measure the volume of protrusion and skin depressions in the area, expressed in mm3.	First day: within 24 hours
First day of study initiation: pinch test	The clinician evaluates the degree of cellulite using a pinch test by applying pressure on the skin between thumb and index finger and assigns a grade from 0 to 4 according to a specific table.	First day: within 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
After 28 days of treatment: recording of any concomitant pharmacological treatments that have occurred.	Any concomitant pharmacological treatments that have occurred are evaluated and recorded.	On the 28th day of treatment
After 28 days of treatment: BMI	Evaluation of height (cm) and weight (Kg) for the calculation of the body mass index, considered in the range 18.5 - 30. In particular, at T2 the minimum acceptable clinical improvement in skin profile measurement will be evaluated (equal to a reduction in the depth of skin depressions of 8-10 mm3.	On the 28th day of treatment
After 28 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference	Measurement of: waist circumference;; hip circumference;; thigh circumference. These measurements are taken using a flexible tape measure with the subject barefoot, in an upright position and, in the specific case of the measurement of the thigh, 1 cm below the crease of the buttock.	On the 28th day of treatment
After 28 days of treatment: digital photographs of the area to be treated	Digital photographs of the area to be treated, taken in profile and three-quarter view with a model camera Nikon Digital Camera.	On the 28th day of treatment
After 28 days of treatment: skin profilemetry of the thigh	Evaluation of the skin profilemetry of the thigh in a predetermined target area, through a computerized analysis Antera 3D CS Camera and 3.X software set (Mitavex, Dublin, Ireland). The images obtained allow the operator to measure the volume of protrusion and skin depressions in the area, expressed in mm3.	On the 28th day of treatment
After 28 days of treatment: pinch test	The clinician evaluates the degree of cellulite using a pinch test by applying pressure on the skin between thumb and index finger and assigns a grade from 0 to 4 according to a specific table.	On the 28th day of treatment
After 28 days of treatment: AE or AED or Drop-off	Recording of any adverse event (AE) or adverse device event (AED) or drop-off.	On the 28th day of treatment
After 28 days of treatment: satisfaction evaluation and compliance	Overall evaluation by each clinical study subject of satisfaction and compliance.	On the 28th day of treatment
After 56 days of treatment: recording of any concomitant pharmacological treatments that have occurred.	Any concomitant pharmacological treatments that have occurred are evaluated and recorded.	On the 56th day of treatment
After 56 days of treatment: BMI	Evaluation of height (cm) and weight (Kg) for the calculation of the body mass index, considered in the range 18.5 - 30. In particular, at T2 the minimum acceptable clinical improvement in skin profile measurement will be evaluated (equal to a reduction in the depth of skin depressions of 8-10 mm3.	On the 56th day of treatment
After 56 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference	Measurement of: waist circumference;; hip circumference;; thigh circumference. These measurements are taken using a flexible tape measure with the subject barefoot, in an upright position and, in the specific case of the measurement of the thigh, 1 cm below the crease of the buttock.	On the 56th day of treatment
After 56 days of treatment: digital photographs of the area to be treated	Digital photographs of the area to be treated, taken in profile and three-quarter view with a model camera Nikon Digital Camera.	On the 56th day of treatment
After 56 days of treatment: skin profilemetry of the thigh	Evaluation of the skin profilemetry of the thigh in a predetermined target area, through a computerized analysis Antera 3D CS Camera and 3.X software set (Mitavex, Dublin, Ireland). The images obtained allow the operator to measure the volume of protrusion and skin depressions in the area, expressed in mm3.	On the 56th day of treatment
After 56 days of treatment: pinch test	The images obtained allow the operator to measure the volume of protrusion and skin depressions in the area, expressed in mm3.	On the 56th day of treatment
After 56 days of treatment: AE or AED or Drop-off	Recording of any adverse event (AE) or adverse device event (AED) or drop-off.	On the 56th day of treatment
After 56 days of treatment: evaluation of compliance	Evaluation of compliance by each clinical study subject. Adherence to the treatment is verified by asking the patient to keep a diary in which to note the morning and evening application, any adverse events that may occur and any medication taken.	On the 56th day of treatment
After 56 days of treatment: overall rating of product satisfaction	For the overall evaluation of patient satisfaction with the product, subjects will be asked to respond to a questionnaire.	On the 56th day of treatment

Collaborators and Investigators

• Sponsor: ICIM International S.r.l.
• Investigators: Principal Investigator: Santo Raffaele Mercuri, I.R.C.C.S. Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Actual): March 20, 2024
• Study Completion (Actual): April 19, 2024

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: cellulite; anti-cellulite treatment; 2nd and 3rd degree cellulite; medical device for the treatment of cellulite; cream-gel for cellulite; edematous fibrosclerotic panniculopathy
• Additional Relevant MeSH Terms: Skin Manifestations; Cellulite
• Other Study ID Numbers: DEFBODY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No