Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast

Breast Enhancement Clinical Trial

— COBRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299532
• Other study ID #: 31GB0801
• Status: Completed
• Phase: Phase 4
• Start date: November 2008
• Est. completion date: October 2013

Study information

• Verified date: February 2011
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 2013
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Enhancement

Intervention

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.

Locations

Country	Name	City	State
France	L'Institute du Sein	Paris
France	Sainte Anne	Paris
Sweden	Akademikliniken	Stockholm
Sweden	Plastikkirurggruppen	Stockholm
Sweden	Proforma Clinic	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

France,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived improvement of shape and fullness of the female breast compared to baseline as judged by the subject using GEIS.		6 months
Secondary	To evaluate the safety as documented by physical examination, mammography, ultrasonography and by adverse events reported.		24 months
Secondary	To evaluate adverse experiences occurring during the first 2 weeks post treatment as recorded in the diary.		2 weeks
Secondary	to study the implant duration and localization as documented by MRI.		24 months
Secondary	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
Secondary	to evaluate the subjects satisfaction with her breast and general appearance using a subject questionnaire.		24 months
Secondary	to evaluate pain experience during injection under local anesthesia.		during injection
Secondary	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
Secondary	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
Secondary	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
Secondary	Re-treatment phase: To evaluate adverse experiences occurring during the first 2 weeks post re-treatment as recorded in the diary.		2 weeks
Secondary	Re-treatment phase: To study the implant duration and localization as documented by MRI up to 24 months after re-treatment.		24 months
Secondary	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
Secondary	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
Secondary	Re-treatment phase: To evaluate pain experience during re-injection under local anaesthesia.		During re-injection
Secondary	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
Secondary	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
Secondary	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