Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348615
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2024-01-25
Brief Title:
Study Aimed at Evaluation of the Effectiveness and Tolerability of an Anti-cellulite Cream Medical Device
Sponsor:
ICIM International Srl a socio unico
Organization:
ICIM International Srl a socio unico
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEFBODY
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 patients overall assessment of satisfaction and compliance will be carried out only at the last visit
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 patients overall assessment of satisfaction and compliance will be carried out only at the last visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None