Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks (NCT NCT01331408)

NCT ID: NCT01331408

Last Updated: 2022-09-28

Results Overview

To evaluate the perceived improvement at 6 months compared to baseline as judged by the Subject using Global Esthetic Improvement Scale (GEIS). Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 61 participants
• Primary outcome timeframe: 6 Months
• Results posted on: 2022-09-28

Participant Flow

Participant milestones

Measure	Macrolane VRF30 Injection of Macrolane VRF30 in buttocks Macrolane VRF30: Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject
Overall Study STARTED	61
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks

Baseline characteristics by cohort

Measure	Macrolane VRF30 n=61 Participants Injection of Macrolane VRF30 in buttocks Macrolane VRF30: Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject
Age, Continuous	41.3 years n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: Intention to treat, subjects with available data

To evaluate the perceived improvement at 6 months compared to baseline as judged by the Subject using Global Esthetic Improvement Scale (GEIS).

Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation.

Outcome measures

Measure	Macrolane VRF30 n=56 Participants Injection of Macrolane VRF30 in buttocks Macrolane VRF30: Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6	80.4 percentage of participants Interval 67.6 to 89.8

SECONDARY outcome

Timeframe: 1 Month

Population: Intention to treat, subjects with available data

To evaluate the perceived improvement at 1 month compared to baseline as judged by the Subject using GEIS.

Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation.

Outcome measures

Measure	Macrolane VRF30 n=57 Participants Injection of Macrolane VRF30 in buttocks Macrolane VRF30: Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 1	91.2 percentage of participants Interval 80.7 to 97.1

SECONDARY outcome

Timeframe: 12 Months

Population: Intention To Treat. Subjects with data available

To Evaluate the Perceived Improvement at 12 Months Compared to Baseline as Judged by the Subject Using GEIS.

Percentage of subjects with Improved, Much Improved or Very Much Improved on GEIS, Subject's evaluation.

Outcome measures

Measure	Macrolane VRF30 n=50 Participants Injection of Macrolane VRF30 in buttocks Macrolane VRF30: Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 12	68.0 percentage of participants Interval 53.3 to 80.5

Adverse Events

Macrolane VRF30

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Macrolane VRF30 n=61 participants at risk Injection of Macrolane VRF30 in buttocks Macrolane VRF30: Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject
Surgical and medical procedures Lipectomy	1.6% 1/61 • Number of events 1 • From treatment up to 24 months
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	1.6% 1/61 • Number of events 1 • From treatment up to 24 months

Other adverse events

Measure	Macrolane VRF30 n=61 participants at risk Injection of Macrolane VRF30 in buttocks Macrolane VRF30: Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject
General disorders Injection Site Pain	6.6% 4/61 • Number of events 4 • From treatment up to 24 months
General disorders Implant Site Pruritus	6.6% 4/61 • Number of events 4 • From treatment up to 24 months
General disorders Implant Site Pain	6.6% 4/61 • Number of events 4 • From treatment up to 24 months
General disorders Implant Site Haematoma	6.6% 4/61 • Number of events 4 • From treatment up to 24 months
General disorders Implant Site Swelling	9.8% 6/61 • Number of events 6 • From treatment up to 24 months

Additional Information

Head of Medical Affairs

Galderma Uppsala

Phone: +46 (0)18 474 9000

Email: receptionen.SEUPP@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication or presentation by PI shall be submitted to Q-Med for review no less than 60 days before submission for publication or presentation. Q-Med will provide any comments to PI within thirty (30) days following receipt of the proposed publication/presentation. PI agree to consider, discuss and give reasonable considerations to comments by Q-Med. Q-Med may also request that the Company name (or that of Q-Med employee) appear or not appear in such publication.
• Publication restrictions are in place

Restriction type: OTHER