An interventional study of Anti-cellulite cream-gel Medical Device (DEFBODY) in Cellulite, sponsored by ICIM International S.r.l.. Completed at 1 site in Italy. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by ICIM International S.r.l. · Not applicable, Interventional, and Treatment
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.
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.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 56 is above the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →ICIM International S.r.l. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: First day: within 24 hours
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: On the 56th day of treatment
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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ICIM International S.r.l.