Trial Outcomes & Findings for Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane (NCT NCT00931268)

Results Overview

Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = "no pain" to the left and 100 = "worst possible pain" to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The VAS pain at 6 months was compared to baseline and the change was calculated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

6 months after treatment compared to baseline

Results posted on

2022-09-28

Participant Flow

First subject enrolled (screened) and treated: 11 August 2009. Last subject completed study: 2 September 2011.

Participant milestones

Participant milestones
Measure	Macrolane VRF 30 Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
Overall Study STARTED	10
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Macrolane VRF 30 Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
Overall Study Lost to Follow-up	6

Baseline Characteristics

Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Macrolane VRF 30 n=10 Participants Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	44.6 years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment France	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after treatment compared to baseline

Population: All efficacy analyses were performed using the intention to treat (ITT) population. The ITT population at baseline and 6 months comprised all 10 treated subjects.

Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = "no pain" to the left and 100 = "worst possible pain" to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The VAS pain at 6 months was compared to baseline and the change was calculated.

Outcome measures

Outcome measures
Measure	Macrolane VRF 30 n=10 Participants Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting	-28.1 mm Standard Deviation 22.2

SECONDARY outcome

Timeframe: Baseline and up to 18 months after treatment

Population: The VAS pain at 1, 3, 9, 12 and 18 months after treatment was compared to baseline. Of 10 treated subjects the ITT populations at each time point was: 9 (1 month), 8 (3 months), 7 (9 months), 5 (12 months) and 4 (18 months).

Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = "no pain" to the left and 100 = "worst possible pain" to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The change in VAS pain was assessed at the time points 1, 3, 9, 12 and 18 months compared to baseline.

Outcome measures

Outcome measures
Measure	Macrolane VRF 30 n=10 Participants Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting VAS pain; change from 18 months to baseline	-15.8 mm Standard Deviation 12.7
Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting VAS pain; change from 1 month to baseline	-14.3 mm Standard Deviation 15.3
Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting VAS pain; change from 3 months to baseline	-40.3 mm Standard Deviation 8.9
Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting VAS pain; change from 9 months to baseline	-29.4 mm Standard Deviation 22.3
Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting VAS pain; change from 12 months to baseline	-22.4 mm Standard Deviation 25.2

SECONDARY outcome

Timeframe: Baseline and at 6 months after treatment

Population: The physical and mental health summary scores at 6 months after treatment were compared to baseline. The ITT population comprised 8 of 10 treated subjects.

A physical health summary score and a mental health summary score was generated on a rating scale of 0 to 100 where higher scores indicate better health. The change in health summary scores were assessed at the time points 3, 6, 9, 12 and 18 months compared to baseline.

Outcome measures

Outcome measures
Measure	Macrolane VRF 30 n=8 Participants Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire Physical health; change from 6 months to baseline	9.0 units on a scale Standard Deviation 6.2
Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire Mental health; change from 6 months to baseline	5.1 units on a scale Standard Deviation 15.6

SECONDARY outcome

Timeframe: One month and up to 18 months after treatment

Population: The ITT population at 6 months comprised all 10 treated subjects.

Number of participants maintaining an improvement compared to baseline using the Global Esthetic Improvement Scale (GEIS) consisting of 5 grades (worse/no change/improved/much improved/very much improved), where the three latter indicates improvement. GEIS was assessed at the time points 1, 3, 6, 9, 12 and 18 months compared to pre-treatment photos.

Outcome measures

Outcome measures
Measure	Macrolane VRF 30 n=10 Participants Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
Number of Participants With Global Esthetic Improvement Subject assessed improvement at 6 months	10 participants
Number of Participants With Global Esthetic Improvement Physician assessed improvement at 6 months	10 participants

SECONDARY outcome

Timeframe: 12 months after treatment

MRI was performed at baseline and at 1, 6, 9, and 12 months to determine the implant volume, thickness, localization and the possible local displacement of the implant. At the 6, 9 and 12 month visits any displacement was evaluated with MRI by comparison to the 1-month position of the gel. The number of participants with gel displacement are shown below.

Outcome measures

Outcome measures
Measure	Macrolane VRF 30 n=6 Participants Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI) Gel displacement right buttock	0 participants
Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI) Gel displacement left buttock	0 participants

SECONDARY outcome

Timeframe: Up to 18 months after treatment

Population: Reported AEs, Safety population

Adverse events (AEs) were collected by open questioning, investigator findings, spontaneous reports and by direct questioning in the Case Report Form (CRF).

Outcome measures

Outcome measures
Measure	Macrolane VRF 30 n=10 Participants Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
Adverse Event Recording	3 participants

SECONDARY outcome

Timeframe: Baseline and at 6 months after treatment

Population: The ITT population at 6 months comprised all 10 treated subjects.

Evaluation of when (in minutes) it became impossible for the subject to stay in the sitting position on a standardized chair, at the time points 1, 3, 6, 9, 12 and 18 months compared to baseline. In this analysis "more than 60 minutes" was handled as 60 minutes.

Outcome measures

Outcome measures
Measure	Macrolane VRF 30 n=10 Participants Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
Time Until it Became Impossible to Stay Sitting Mean value at baseline	23.8 minutes Standard Deviation 4.1
Time Until it Became Impossible to Stay Sitting Mean value at 6 months	59.0 minutes Standard Deviation 3.2

Adverse Events

Macrolane VRF 30

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Macrolane VRF 30 n=10 participants at risk Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
General disorders Implant site effusion	20.0% 2/10 • Number of events 2 • From treatment up to 18 months. Adverse events (AEs) were collected by open questioning, investigator findings, spontaneous reports and by direct questioning in the Case Report Form (CRF).
General disorders Injection site inflammation	30.0% 3/10 • Number of events 3 • From treatment up to 18 months. Adverse events (AEs) were collected by open questioning, investigator findings, spontaneous reports and by direct questioning in the Case Report Form (CRF).

Additional Information

Head of Clinical Development

Q-Med AB

Phone: +46 (0)18 4749000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60