Macrolane Prospective Survey

Females Recently Treated With Macrolane VRF in the Breasts Clinical Trial

Official title:

A Multi-center, Non-interventional, Prospective Study to Monitor Long Term Safety in Female Subjects After Treatment With Macrolane Volume Restoration Factor 20 and/or Macrolane Volume Restoration Factor 30 in the Breasts.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01223066
• Other study ID #: 31GB0906
• Status: Withdrawn
• Start date: September 2010
• Est. completion date: October 2010

Study information

• Verified date: November 2012
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study objective is to evaluate the long term safety when Macrolane Volume Restoration Factor is used in female breasts in clinical practice.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Females recently treated with Macrolane Volume Restoration Factor in the breasts.
• Signed informed consent

Exclusion Criteria:

• There are no exclusion criteria

Related Conditions & MeSH terms

• Females Recently Treated With Macrolane VRF in the Breasts

Locations

Country	Name	City	State
Sweden	Akademikliniken	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Galderma R&D	Pharma Consulting Group AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		up to 5 years