Clinical trial NCT01299532: Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Enhancement
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 71
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Perceived improvement of shape and fullness of the female breast compared to baseline as judged by the subject using GEIS.
timeFrame: 6 months
Secondary outcomes:
measure: To evaluate the safety as documented by physical examination, mammography, ultrasonography and by adverse events reported.
timeFrame: 24 months
measure: To evaluate adverse experiences occurring during the first 2 weeks post treatment as recorded in the diary.
timeFrame: 2 weeks
measure: to study the implant duration and localization as documented by MRI.
timeFrame: 24 months
measure: to evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS.
timeFrame: 24 months
measure: to evaluate the subjects satisfaction with her breast and general appearance using a subject questionnaire.
timeFrame: 24 months
measure: to evaluate pain experience during injection under local anesthesia.
timeFrame: during injection
measure: 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
timeFrame: 24 months
measure: 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.
timeFrame: 39 months
measure: 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).
timeFrame: 48 months
measure: Re-treatment phase: To evaluate adverse experiences occurring during the first 2 weeks post re-treatment as recorded in the diary.
timeFrame: 2 weeks
measure: Re-treatment phase: To study the implant duration and localization as documented by MRI up to 24 months after re-treatment.
timeFrame: 24 months
measure: 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.
timeFrame: 24 months
measure: 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.
timeFrame: 24 months
measure: Re-treatment phase: To evaluate pain experience during re-injection under local anaesthesia.
timeFrame: During re-injection
measure: 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.
timeFrame: 9 months
measure: 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.
timeFrame: 24 months
measure: 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.
timeFrame: 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Sainte Anne
city: Paris
country: France
facility: L'Institute du Sein
city: Stockholm
country: Sweden
facility: Plastikkirurggruppen
city: Stockholm
country: Sweden
facility: Akademikliniken
city: Stockholm
country: Sweden
facility: Proforma Clinic
Study officials:
affiliation: Akademikliniken, Stockholm, Sweden
name: Per Hedén, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: