CelluliteDEFBODYNCT06348615
Study Aimed at Evaluation of the Effectiveness and Tolerability of an Anti-cellulite Cream Medical Device
A study testing Anti-cellulite cream-gel Medical Device (DEFBODY) in people with Cellulite, run by ICIM International S.r.l. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite
- What is being tested?
- Anti-cellulite cream-gel Medical Device (DEFBODY)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jan 2024to 19 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cellulite
- Being tested
- Anti-cellulite cream-gel Medical Device (DEFBODY)
- Keywords
- cellulite, anti-cellulite treatment, 2nd and 3rd degree cellulite, medical device for the treatment of cellulite, cream-gel for cellulite, edematous fibrosclerotic panniculopathy
- Medical subject headings
- Cellulite, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-cellulite cream-gel Medical Device (DEFBODY)Device
one bottle of 400 ml, twice a day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Anti-cellulite cream-gel Medical Device (DEFBODY) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First day: within 24 hours
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: On the 56th day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start24 Jan 2024
- Primary completion20 Mar 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CelluliteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- ICIM International S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Santo Raffaele Mercuri, Principal investigator, I.R.C.C.S. Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348615
- Sponsor's protocol ID
- DEFBODY
- Acronym
- DEFBODY
- Status last verified
- Jul 2025
- First submitted
- 25 Jan 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06348615
- Acronym / sponsor ID
- DEFBODY / DEFBODY
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- ICIM International S.r.l.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm: 1 bottle (cream-gel) 400ml | Experimental | Device: Anti-cellulite cream-gel Medical Device (DEFBODY)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-cellulite cream-gel Medical Device (DEFBODY)one bottle of 400 ml, twice a day | Device | Single arm: 1 bottle (cream-gel) 400ml |
Primary outcome
First day of study initiation: clinical history; personal and demographic data and previous or concomitant treatments
Time frame: First day: within 24 hours
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 of study initiation: BMI
Time frame: First day: within 24 hours
Evaluation of height (cm) and weight (Kg) for the calculation of the body mass index, considered in the range 18.5 - 30.
First day of study initiation: Measurement of waist circumference, hip circumference and thigh circumference
Time frame: First day: within 24 hours
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 of study initiation: digital photographs of the area to be treated
Time frame: First day: within 24 hours
digital photographs of the area to be treated, taken in profile and three-quarter view with a model camera Nikon Digital Camera.
First day of study initiation: skin profilemetry of the thigh
Time frame: First day: within 24 hours
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 of study initiation: pinch test
Time frame: First day: within 24 hours
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.
17 secondary outcomes
After 28 days of treatment: recording of any concomitant pharmacological treatments that have occurred.
Time frame: On the 28th day of treatment
After 28 days of treatment: BMI
Time frame: On the 28th day of treatment
After 28 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference
Time frame: On the 28th day of treatment
After 28 days of treatment: digital photographs of the area to be treated
Time frame: On the 28th day of treatment
After 28 days of treatment: skin profilemetry of the thigh
Time frame: On the 28th day of treatment
After 28 days of treatment: pinch test
Time frame: On the 28th day of treatment
After 28 days of treatment: AE or AED or Drop-off
Time frame: On the 28th day of treatment
After 28 days of treatment: satisfaction evaluation and compliance
Time frame: On the 28th day of treatment
After 56 days of treatment: recording of any concomitant pharmacological treatments that have occurred.
Time frame: On the 56th day of treatment
After 56 days of treatment: BMI
Time frame: On the 56th day of treatment
After 56 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference
Time frame: On the 56th day of treatment
After 56 days of treatment: digital photographs of the area to be treated
Time frame: On the 56th day of treatment
After 56 days of treatment: skin profilemetry of the thigh
Time frame: On the 56th day of treatment
After 56 days of treatment: pinch test
Time frame: On the 56th day of treatment
After 56 days of treatment: AE or AED or Drop-off
Time frame: On the 56th day of treatment
After 56 days of treatment: evaluation of compliance
Time frame: On the 56th day of treatment
After 56 days of treatment: overall rating of product satisfaction
Time frame: On the 56th day of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santo Raffaele Mercuri principal investigator
I.R.C.C.S. Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-cellulite cream-gel Medical Device (DEFBODY) in people with Cellulite, run by ICIM International S.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First day of study initiation: clinical history; personal and demographic data and previous or concomitant treatments (time frame: First day: within 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.