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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01331408
First received: April 5, 2011
Last updated: May 31, 2012
Last verified: April 2011
  Purpose

The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume restoration and shaping of the buttocks.


Condition Intervention Phase
Volume Restoration and Shaping of the Buttocks
Device: Macrolane VRF30
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks

Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • To evaluate the perceived improvement at 6 months compared to baseline as judged by the Subject using Global Esthetic Improvement Scale (GEIS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    GEIS=Global Esthetic Improvement Scale (Very much improved, Much improved, Improved, No change, Worse) The categorical efficacy variable GEIS as assessed by the subject and the investigator will be summarized by counts and percentages in frequency tables by visit.


Secondary Outcome Measures:
  • To evaluate the perceived improvement at 1 month and 12 months compared to baseline as judged by the Subject using GEIS. [ Time Frame: 1 month, 12 months ] [ Designated as safety issue: No ]
  • To evaluate the perceived improvement at 1, 6 and 12 months compared to baseline as judged by the investigator using GEIS. [ Time Frame: 1,6 and 12 months ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability over 12 months, based on evaluation of reported adverse events (AEs). [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    Adverse Events will be summarized in a frequency table and according to MEdDRA preferred term and intensity.

    All subjects with AEs will be listed individually with subject number in addition to type of event, start and stop time of event, duration of event, seriousness, intensity, causality, action taken and outcome of the adverse event.


  • To evaluate the event of capsular contraction over 12 months, based on the appearance and tenderness of the Subject's buttocks as graded by the investigator. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To evaluate anticipated adverse events occurring during the first 2 weeks after treatment and to evaluate pain experienced during injection under local anesthesia. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate whether parameters of the injection procedure have effect on safety or perceived improvement (subject's GEIS assessment and Investigator's GEIS assessment). [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To evaluate the Subject's satisfaction with his/her buttocks and general appearance up to 12 months using the Subject's questionnaire. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To follow-up items 1-4, and item 7 up to 24 months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    -evaluate the perceived improvement at 18 and 24 months compared to baseline as judged by the subject using GEIS -to evaluate the perceived improvement at 18 and 24 months compared to baseline as judged by the Investigator using GEIS -to evaluate the safety and and tolerability over 24 months, based on evaluation or reported adverse events (AEs)-to evalute the event of capsular contraction over 24 months, as graded by the investigator -to evaluate the subject's satisfaction with his/her buttocks and general appearance up to 24 months using the subject's questionnaire.

  • To assess whether inflammatory response is elicited by the implant, using blood sample analysis and body temperature of the first 8 treated Subjects in Sweden. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • To study, by Magnetic Resonance Imaging, the implant duration, localization and mobility up to 24 months in the first 8 treated Subjects in Sweden. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: September 2008
Study Completion Date: May 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Macrolane VRF30
Injection of Macrolane VRF30 in buttocks
Device: 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
Other Name: Macrolane VRF30

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ≥ 20 years old
  • willing to undergo augmentation therapy of the buttocks where a maximum total injected volume of 400 ml of the study product is judged by the Investigator to be enough to achieve full correction
  • understand and comply with the requirements of the study
  • be willing to understand and comply with the requirements of the study
  • be willing to abstain from esthetic surgery and esthetical augmentation procedures (other than the study treatment) between the umbilicus and the knees.
  • be a male or non-pregnant, non breast-feeding female.
  • give written informed consent to participate in the study

Exclusion Criteria:

  • Active skin disease, inflammation or related conditions Tumors or pre-malign tissue disorder near or on the area to be treated
  • scar tissue in the area to be treated
  • subjects seeking corrections for other body parts then the buttocks anywhere between the umbilicus and the knees
  • subjects with human immunodeficiency virus (HIV) associated lipodystrophy
  • subjects having undergone liposuction within 6 months prior to inclusion
  • BMI <20 or expected instable weight
  • insufficient tissue cover in the area to be treated
  • excessive skin laxity in the area to be treated
  • other injectable implant or permanent implant near or in the area to be treated
  • previous radiation therapy of tumors near or in the area to be treated
  • concomitant anticoagulant therapy, anti-platelet therapy or a history of bleeding disorders.
  • a presence or history of connective tissue diseases
  • ongoing immunosuppressive therapy
  • known allergies or hypersensitivity reactions towards anesthetics
  • previous inflammatory or hypersensitivity reactions towards products containing Hyaluronic acid
  • any condition which in the opinion of the investigator makes the subject unsuitable for inclusion use of any investigational drugs or devices within 30 days prior to inclusion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331408

Locations
Belgium
Artemedis Center for Plastic Surgery
Sint-Denijs-Westrem, Belgium, 9051
Spain
Centro Clinico Mir-Mir
Barcelona, Spain, 08006
Cirugia Plastica
Madrid, Spain, 28046
Sweden
Akademikliniken
Stockholm, Sweden, 115 42
Sponsors and Collaborators
Q-Med AB
Investigators
Principal Investigator: Per Hedén, M.D. Akademikliniken, Storängsvägen 10, 115 42 Stockholm, Sweden
  More Information

No publications provided by Q-Med AB

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01331408     History of Changes
Other Study ID Numbers: 31GC0609
Study First Received: April 5, 2011
Last Updated: May 31, 2012
Health Authority: Sweden: Regional Ethical Review Board
Spain: Ethics Committee
Belgium: Ethics Committee

ClinicalTrials.gov processed this record on July 23, 2014