Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast

Phase 4

Completed

• Conditions: Breast Enhancement
• Interventions: Device: Macrolane VRF30

• Registration Number: NCT01299532
• Lead Sponsor: Galderma R&D

Brief Summary

This is an open, multi-center, non comparative study to evaluate the safety and efficacy of Macrolane VRF30 in the female breast. 71 subjects have received initial treatment with a maximum of 120 ml of Macrolane VRF30 per breast. 22 patients have received a re-injection (max 120 ml/breast) of Macrolane nine months after initial treatment. Patients are followed for 24 months after last treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2010-06
• Status Verified: 2011-02
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-18
• Study Completion: 2013-10
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

Inclusion Criteria

• Patients between 25 and 60 years with small breasts seeking enhancement of the shape and fullness of the breast

Exclusion Criteria

• Unreasonable expectations as regards the increase in breast volume
• Any medical conditions that may interfere in any way.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Macrolane VRF30	Macrolane VRF30	-

Primary Outcome Measures

Name	Time	Method
Perceived improvement of shape and fullness of the female breast compared to baseline as judged by the subject using GEIS.	6 months

Secondary Outcome Measures

Name	Time	Method
to evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS.	24 months
To evaluate the safety as documented by physical examination, mammography, ultrasonography and by adverse events reported.	24 months
to evaluate pain experience during injection under local anesthesia.	during injection
To evaluate adverse experiences occurring during the first 2 weeks post treatment as recorded in the diary.	2 weeks
to study the implant duration and localization as documented by MRI.	24 months
to evaluate the subjects satisfaction with her breast and general appearance using a subject questionnaire.	24 months
To evaluate any difficulties with the interpretation of the mammography image(s)or ultrasonography due to the presence of the implant 24 months after the initial treatment	24 months
Re-treatment phase: To evaluate the safety documented by physical examination and by adverse events reported up to 24 months after re-treatment and by mammography and ultrasonography examinations 15 and 39 months after re-treatment.	39 months
Re-treatment phase: To evaluate adverse experiences occurring during the first 2 weeks post re-treatment as recorded in the diary.	2 weeks
Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 24 months after last treatment between subjects that have received only one treatment and subjects that have received re-treatment.	24 months
Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 12 and 24 months after initial treatment between subjects that have received only one treatment and subjects that have received re-treatment.	24 months
Re-treatment phase: To evaluate any difficulties with the interpretation of the mammography image(s) or ultrasonography due to the presence of the implant 24 and 48 months after the initial treatment (15 and 39 months after the re-treatment).	48 months
Re-treatment phase: To study the implant duration and localization as documented by MRI up to 24 months after re-treatment.	24 months
Re-treatment phase: To evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS up to 24 months after re-treatment.	24 months
Re-treatment phase: To evaluate, up to 24 months after re-treatment, the subjects satisfaction with her breast and general appearance using a subject questionnaire.	24 months
Re-treatment phase: To evaluate pain experience during re-injection under local anaesthesia.	During re-injection
Re-treatment phase: To evaluate if there are differences in esthetic improvement, subject satisfaction and implant duration, after re-treatment compared to after initial treatment. The visits up to 9 months will be compared.	9 months

Trial Locations

Locations (5)

Sainte Anne; 🇫🇷 Paris, France

L'Institute du Sein; 🇫🇷 Paris, France

Plastikkirurggruppen; 🇸🇪 Stockholm, Sweden

Proforma Clinic; 🇸🇪 Stockholm, Sweden

Akademikliniken; 🇸🇪 Stockholm, Sweden