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

ICIM International S.r.l.

Status: Completed

Conditions: Cellulite

Treatments: Device: Anti-cellulite cream-gel Medical Device (DEFBODY)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06348615

DEFBODY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

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