protocolSection identificationModule nctId: NCT06348615, orgStudyIdInfo id: DEFBODY, briefTitle: Study Aimed at Evaluation of the Effectiveness and Tolerability of an Anti-cellulite Cream Medical Device, acronym: DEFBODY, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2024-04-23, completionDateStruct date: 2024-06-07, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: ICIM International S.r.l. a socio unico, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Cellulite, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Anti-cellulite cream-gel Medical Device (DEFBODY), outcomesModule primaryOutcomes measure: First day of study initiation: clinical history; personal and demographic data and previous or concomitant treatments, primaryOutcomes measure: First day of study initiation: BMI, primaryOutcomes measure: First day of study initiation: Measurement of waist circumference, hip circumference and thigh circumference, primaryOutcomes measure: First day of study initiation: digital photographs of the area to be treated, primaryOutcomes measure: First day of study initiation: skin profilemetry of the thigh, primaryOutcomes measure: First day of study initiation: pinch test, secondaryOutcomes measure: After 28 days of treatment: recording of any concomitant pharmacological treatments that have occurred., secondaryOutcomes measure: After 28 days of treatment: BMI, secondaryOutcomes measure: After 28 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference, secondaryOutcomes measure: After 28 days of treatment: digital photographs of the area to be treated, secondaryOutcomes measure: After 28 days of treatment: skin profilemetry of the thigh, secondaryOutcomes measure: After 28 days of treatment: pinch test, secondaryOutcomes measure: After 28 days of treatment: AE or AED or Drop-off, secondaryOutcomes measure: After 28 days of treatment: satisfaction evaluation and compliance, secondaryOutcomes measure: After 56 days of treatment: recording of any concomitant pharmacological treatments that have occurred., secondaryOutcomes measure: After 56 days of treatment: BMI, secondaryOutcomes measure: After 56 days of treatment: Measurement of waist circumference, hip circumference and thigh circumference, secondaryOutcomes measure: After 56 days of treatment: digital photographs of the area to be treated, secondaryOutcomes measure: After 56 days of treatment: skin profilemetry of the thigh, secondaryOutcomes measure: After 56 days of treatment: pinch test, secondaryOutcomes measure: After 56 days of treatment: AE or AED or Drop-off, secondaryOutcomes measure: After 56 days of treatment: evaluation of compliance, secondaryOutcomes measure: After 56 days of treatment: overall rating of product satisfaction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Dermatology Unit - I.R.C.C.S. Ospedale San Raffaele, status: RECRUITING, city: Milano, country: Italy, contacts name: Santo Raffaele Mercuri, role: CONTACT, contacts name: Vittoria Giulia Bianchi, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False