Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cellulite | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-cellulite cream-gel Medical Device (DEFBODY) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm: 1 bottle (cream-gel) 400ml
- 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.
- interventionNames
- Device: Anti-cellulite cream-gel Medical Device (DEFBODY)
Primary outcomes (6)
- measure
- First day of study initiation: clinical history; personal and demographic data and previous or concomitant treatments
- timeFrame
- First day: within 24 hours
- description
- The following activities are planned on the first day: * clinical history of the recruited subjects; * personal and demographic data; * previous and/or concomitant treatments.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available