Macrolane Retrospective Study

Completed

• Conditions: Women Who Have Had Breast Enhancement With Macrolane VRF

• Registration Number: NCT01223963
• Lead Sponsor: Galderma R&D

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2010-10-15
• Study First Submitted QC: 2010-10-18
• Study First Posted: 2010-10-19
• Status Verified: 2012-11
• Results First Submitted: 2014-03-14
• Results First Submitted QC: 2017-05-12
• Results First Posted: 2017-12-15
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 93

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	01may2008 - 31dec2009	Number of Adverse events reported during the study period

Trial Locations

Locations (2)

Stureplanskliniken; 🇸🇪 Stockholm, Sweden

Akademikliniken; 🇸🇪 Stockholm, Sweden