N/A
N=93
Macrolane Retrospective Study
Women Who Have Had Breast Enhancement With Macrolane VRF
Bottom Line
View on ClinicalTrials.gov: NCT01223963 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Number of Adverse Events — 46 number of AE
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Galderma R&D
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events |
46 | — |
Summary
This is a retrospective, multicenter chart review of medical records on the use of Macrolane for female breast enhancement.
The primary objective is to evaluate the safety profile of Macrolane Volume Restoration Factor 20 and Macrolane Volume Restoration Factor 30 when used for female breast enhancement in clinical practice.
Eligibility Criteria
Inclusion Criteria
- Females treated with Macrolane Volume Restoration Factor 20 and/or Volume Restoration Factor 30 for breast enhancement.
- Signed Informed Consent
Exclusion Criteria
- Subjects that have actively asked not to be contacted by the clinic
- Subjects that have participated or participates in clinical studies with Macrolane for breast enhancement
Data sourced from ClinicalTrials.gov (NCT01223963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.