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.
NCT number | NCT01223066 |
Other study ID # | 31GB0906 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | September 2010 |
Est. completion date | October 2010 |
Verified date | November 2012 |
Source | Galderma R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study objective is to evaluate the long term safety when Macrolane Volume Restoration Factor is used in female breasts in clinical practice.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Akademikliniken | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Galderma R&D | Pharma Consulting Group AB |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events | up to 5 years |