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

NCT06348615 | Completed

• 1 other identifier: DEFBODY
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cellulite

Keywords

cellulite; anti-cellulite treatment; 2nd and 3rd degree cellulite; medical device for the treatment of cellulite; cream-gel for cellulite; edematous fibrosclerotic panniculopathy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (17)

• After 28 days of treatment: recording of any concomitant pharmacological treatments that have occurred.

  On the 28th day of treatment

• After 28 days of treatment: BMI

  On the 28th day of treatment

• After 28 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference

  On the 28th day of treatment

• After 28 days of treatment: digital photographs of the area to be treated

  On the 28th day of treatment

• After 28 days of treatment: skin profilemetry of the thigh

  On the 28th day of treatment

Study Arms (1)

Single arm: 1 bottle (cream-gel) 400ml

EXPERIMENTAL

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)

Interventions

Anti-cellulite cream-gel Medical Device (DEFBODY) DEVICE

one bottle of 400 ml, twice a day

Single arm: 1 bottle (cream-gel) 400ml

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ICIM International S.r.l.: lead

Study Sites (1)

Dermatology Unit - I.R.C.C.S. Ospedale San Raffaele

Milan, Italy

Location

MeSH Terms

Conditions

Cellulite; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Pathologic Processes

Study Officials

• Santo Raffaele Mercuri

  I.R.C.C.S. Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: April 5, 2024
• Study Start: January 24, 2024
• Primary Completion: March 20, 2024
• Study Completion: April 19, 2024
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

IT (1)