Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast (COBRA)

An Open, Multi-center Study Evaluating Efficacy and Safety of Macrolane VRF30 for Enhancement of the Shape and Fullness of the Female Breast

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.

Study Overview

• Status: Completed
• Conditions: Breast Enhancement
• Intervention / Treatment: Device: Macrolane VRF30

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Sainte Anne
  • Paris, France, 75116
    • L'Institute du Sein
• Sweden
  • Stockholm, Sweden, 115 42
    • Akademikliniken
  • Stockholm, Sweden, 113 24
    • Plastikkirurggruppen
  • Stockholm, Sweden, 118 63
    • ProForma Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Macrolane VRF30	Device: Macrolane VRF30; Device: Macrolane VRF30 (stabilized hyaluronic acid of non-animal origin) Treatment: Initial injection of a maximum of 120 ml/breast. Re-injection of a maximum of 120 ml/breast in a subgroup of subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
To evaluate the safety as documented by physical examination, mammography, ultrasonography and by adverse events reported.	24 months
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 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 subjects satisfaction with her breast and general appearance using a subject questionnaire.	24 months
to evaluate pain experience during injection under local anesthesia.	during injection
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 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 evaluate adverse experiences occurring during the first 2 weeks post re-treatment as recorded in the diary.	2 weeks
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
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

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Per Hedén, M.D., Ph.D., Akademikliniken, Stockholm, Sweden

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: February 16, 2011
• First Submitted That Met QC Criteria: February 16, 2011
• First Posted (Estimate): February 18, 2011

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: 31GB0801