NCT06348615

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: ICIM International S.r.l. · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cellulite

Interventions

Type	Name	Description
DEVICE	Anti-cellulite cream-gel Medical Device (DEFBODY)	one bottle of 400 ml, twice a day

Timeline

• Start date: 2024-01-24
• Primary completion: 2024-03-20
• Completion: 2024-04-19
• First posted: 2024-04-05
• Last updated: 2025-07-23

Locations

1 site across 1 country: Italy