Trial Outcomes & Findings for (Macrolane VR30) in Buttocks Reshaping and contouringCellulite (Macrolane VR30) in Buttocks Reshaping and Contouring (NCT NCT02127723)

Last Updated: 2022-08-26

Results Overview

Assess the aesthetic improvement of the buttocks after reshaping in female subjects with cellulite associated with laxity and loss of volume of the buttocks at each follow up visit after treatment using the investigator Global Aesthetic Improvement Scale (GAIS).

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

48 weeks post treatment

Results posted on

2022-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Macrolane All subjects will be treated with Macrolane Hyaluronic acid injection (Macrolane VRF30): Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

(Macrolane VR30) in Buttocks Reshaping and contouringCellulite (Macrolane VR30) in Buttocks Reshaping and Contouring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Macrolane n=20 Participants Att subjects will be treated with Macrolane Hyaluronic acid injection (Macrolane VRF30): Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	48.9 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Brazil	20 participants n=5 Participants
Cellulite severity scale	8 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks post treatment

Population: Global aesthetic improvement was assessed as Very much improved, Much improved, Improved, No change or Worse. Number of improved subjects (i.e. very much improved, much improved or improved) was presented.

Outcome measures

Outcome measures
Measure	Macrolane n=19 Participants All subjects will be treated with Macrolane Hyaluronic acid injection (Macrolane VRF30): Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite
Number of Patients With Aesthetic Improvement of the Buttocks Using Investigator GAIS	7 Participants

PRIMARY outcome

Timeframe: 48 weeks post treatment

Population: Improvement in cellulite at 48 weeks compared to baseline, using the CSS and indicated by the grading reduction.

Assess improvement of cellulite in the buttock areas compared to baseline at each follow up visit after treatment using the Cellulite Severity Scale (CSS). A scale graded 1-15 that measures the severity of cellulites. Grade 1-5 is mild; grade 6-10 is moderate; grade 11-15 is severe.

Outcome measures

Outcome measures
Measure	Macrolane n=19 Participants All subjects will be treated with Macrolane Hyaluronic acid injection (Macrolane VRF30): Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite
Mean Improvement in Cellulite Severity Compared to Baseline Using the Cellulite Severity Scale (CSS)	-1 Units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: 48 weeks post treatment

Population: Number of subjects who were improved at least 1 grade from baseline in items A and/or B and /or D of the CSS.

Assess the CSS responder rate, where a responder is defined as a subject who has improved at least one grade from baseline in items A and/or B and/or D of the CSS.

Outcome measures

Outcome measures
Measure	Macrolane n=19 Participants All subjects will be treated with Macrolane Hyaluronic acid injection (Macrolane VRF30): Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite
Number of CSS Responders	10 Participants

SECONDARY outcome

Timeframe: Until 48 weeks post treatment

Population: Evaluation of safety by assessment of number of related adverse events (AEs)

Number of subjects with related adverse events

Outcome measures

Outcome measures
Measure	Macrolane n=20 Participants All subjects will be treated with Macrolane Hyaluronic acid injection (Macrolane VRF30): Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite
Number of Subjects With Related Adverse Events	10 subjects

Adverse Events

Macrolane

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Macrolane n=20 participants at risk Att subjects will be treated with Macrolane Hyaluronic acid injection (Macrolane VRF30): Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite
General disorders injection site pain	40.0% 8/20 • Number of events 14
General disorders injection site hematoma	10.0% 2/20 • Number of events 3
General disorders injection site puritus	5.0% 1/20 • Number of events 1
General disorders injection site discomfort	10.0% 2/20 • Number of events 4

Additional Information

Q-Med AB

Phone: +46 18 474 9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60