Clinical trial NCT06348615: Study Aimed at Evaluation of the Effectiveness and Tolerability of an Anti-cellulite Cream Medical Device
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: ICIM International S.r.l.
Sponsor class: INDUSTRY
First posted: 2024-04-05
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: First day of study initiation: clinical history; personal and demographic data and previous or concomitant treatments
timeFrame: First day: within 24 hours
measure: First day of study initiation: BMI
timeFrame: First day: within 24 hours
measure: First day of study initiation: Measurement of waist circumference, hip circumference and thigh circumference
timeFrame: First day: within 24 hours
measure: First day of study initiation: digital photographs of the area to be treated
timeFrame: First day: within 24 hours
measure: First day of study initiation: skin profilemetry of the thigh
timeFrame: First day: within 24 hours
measure: First day of study initiation: pinch test
timeFrame: First day: within 24 hours
Secondary outcomes:
measure: After 28 days of treatment: recording of any concomitant pharmacological treatments that have occurred.
timeFrame: On the 28th day of treatment
measure: After 28 days of treatment: BMI
timeFrame: On the 28th day of treatment
measure: After 28 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference
timeFrame: On the 28th day of treatment
measure: After 28 days of treatment: digital photographs of the area to be treated
timeFrame: On the 28th day of treatment
measure: After 28 days of treatment: skin profilemetry of the thigh
timeFrame: On the 28th day of treatment
measure: After 28 days of treatment: pinch test
timeFrame: On the 28th day of treatment
measure: After 28 days of treatment: AE or AED or Drop-off
timeFrame: On the 28th day of treatment
measure: After 28 days of treatment: satisfaction evaluation and compliance
timeFrame: On the 28th day of treatment
measure: After 56 days of treatment: recording of any concomitant pharmacological treatments that have occurred.
timeFrame: On the 56th day of treatment
measure: After 56 days of treatment: BMI
timeFrame: On the 56th day of treatment
measure: After 56 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference
timeFrame: On the 56th day of treatment
measure: After 56 days of treatment: digital photographs of the area to be treated
timeFrame: On the 56th day of treatment
measure: After 56 days of treatment: skin profilemetry of the thigh
timeFrame: On the 56th day of treatment
measure: After 56 days of treatment: pinch test
timeFrame: On the 56th day of treatment
measure: After 56 days of treatment: AE or AED or Drop-off
timeFrame: On the 56th day of treatment
measure: After 56 days of treatment: evaluation of compliance
timeFrame: On the 56th day of treatment
measure: After 56 days of treatment: overall rating of product satisfaction
timeFrame: On the 56th day of treatment
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Dermatology Unit - I.R.C.C.S. Ospedale San Raffaele
Study officials:
affiliation: I.R.C.C.S. Ospedale San Raffaele
name: Santo Raffaele Mercuri
role: PRINCIPAL_INVESTIGATOR
References: