Trial Outcomes & Findings for Macrolane for Enhancement of the Shape and Fullness of the Female Breast (NCT NCT01308853)

Results Overview

Inclusion was made in steps in group of 4 subjects. The subjects were followed-up with MRI 1-5 days after the injection to document correct injection technique. Before the next group were treated, the Expert Group evaluated the 6-week follow-up results of the previous group. The injection procedure was, if necessary, changed in accordance with specifically pre-defined parameters.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

6 weeks

Results posted on

2022-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Macrolane Open label Device: Macrolane. Treatment: Initial injection (including touch-up) of a maximum of 120 ml/breast.
Overall Study STARTED	24
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Macrolane Open label Device: Macrolane. Treatment: Initial injection (including touch-up) of a maximum of 120 ml/breast.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	2
Overall Study Insertion of permanent implants	1

Baseline Characteristics

Macrolane for Enhancement of the Shape and Fullness of the Female Breast

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Macrolane n=24 Participants Open label Device: Macrolane. Treatment: Initial injection (including touch-up) of a maximum of 120 ml/breast.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37.4 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Sweden	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: All included participants (Intention To Treat)

Inclusion was made in steps in group of 4 subjects. The subjects were followed-up with MRI 1-5 days after the injection to document correct injection technique. Before the next group were treated, the Expert Group evaluated the 6-week follow-up results of the previous group. The injection procedure was, if necessary, changed in accordance with specifically pre-defined parameters.

Outcome measures

Outcome measures
Measure	Macrolane n=48 Breasts Open label Device: Macrolane. Treatment: Initial injection (including touch-up) of a maximum of 120 ml/breast.
Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment	48 Breasts

SECONDARY outcome

Timeframe: 6 weeks

Population: Intention to treat. Data from 1 participant not available.

Esthetic improvement was evaluated using the Global Esthetic Improvement Scale (GEIS). The scale has five grades ranging from worse to very much improved. Subjects defined as "at least improved" are assessed as improved, much improved or very much improved.

Outcome measures

Outcome measures
Measure	Macrolane n=46 breasts Open label Device: Macrolane. Treatment: Initial injection (including touch-up) of a maximum of 120 ml/breast.
Percentage of Breasts With Improvement as Assessed by the Investigator	100 percentage of breasts

Adverse Events

Macrolane

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Macrolane n=24 participants at risk Open label Device: Macrolane. Treatment: Initial injection (including touch-up) of a maximum of 120 ml/breast.
Reproductive system and breast disorders Breast Tenderness	25.0% 6/24 • Number of events 10 • From day 0 up until 24 months after injection Systematic assessments: Subject diary for collection of expected adverse events. Collection of related and unrelated adverse events at each clinical visit following injection when subjects were asked "Since your last clinical visit have you had any health problems?" Mammography performed. Breast examinations Laboratory assessments
General disorders Capsular contracture associated with breast implant	29.2% 7/24 • Number of events 22 • From day 0 up until 24 months after injection Systematic assessments: Subject diary for collection of expected adverse events. Collection of related and unrelated adverse events at each clinical visit following injection when subjects were asked "Since your last clinical visit have you had any health problems?" Mammography performed. Breast examinations Laboratory assessments
General disorders Injection site pain	8.3% 2/24 • Number of events 3 • From day 0 up until 24 months after injection Systematic assessments: Subject diary for collection of expected adverse events. Collection of related and unrelated adverse events at each clinical visit following injection when subjects were asked "Since your last clinical visit have you had any health problems?" Mammography performed. Breast examinations Laboratory assessments
General disorders Implant site nodule	33.3% 8/24 • Number of events 10 • From day 0 up until 24 months after injection Systematic assessments: Subject diary for collection of expected adverse events. Collection of related and unrelated adverse events at each clinical visit following injection when subjects were asked "Since your last clinical visit have you had any health problems?" Mammography performed. Breast examinations Laboratory assessments
Nervous system disorders Hypoaesthesia	8.3% 2/24 • Number of events 2 • From day 0 up until 24 months after injection Systematic assessments: Subject diary for collection of expected adverse events. Collection of related and unrelated adverse events at each clinical visit following injection when subjects were asked "Since your last clinical visit have you had any health problems?" Mammography performed. Breast examinations Laboratory assessments
Reproductive system and breast disorders Breast discomfort	8.3% 2/24 • Number of events 3 • From day 0 up until 24 months after injection Systematic assessments: Subject diary for collection of expected adverse events. Collection of related and unrelated adverse events at each clinical visit following injection when subjects were asked "Since your last clinical visit have you had any health problems?" Mammography performed. Breast examinations Laboratory assessments

Additional Information

Dr. Per Hedén

Akademikliniken, Stockholm, Sweden

Phone: +46 8 614 54 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Individual publications shall not be made prior to the first, multi-center publication of the results of the multicenter study. The Investigator shall have the right to publish the results of his work. Any publication or presentation by Institution and/or Principal Investigator shall be submitted to Q Med for review and comment no less than 60 days before submission to allow Q Med to determine whether any patentable invention or Confidential Information would be disclosed.
Publication restrictions are in place

Restriction type: OTHER