N/A N=24 Treatment

Macrolane for Enhancement of the Shape and Fullness of the Female Breast

Breast Enhancement

Bottom Line

View on ClinicalTrials.gov: NCT01308853 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment — 48 Breasts

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Macrolane (Device)
Age: Adult · 25+ yrs
Sex: Female
Sponsor: Galderma R&D
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment	48	—
SECONDARY Percentage of Breasts With Improvement as Assessed by the Investigator	100	—

Summary

The study evaluates treatment procedure, efficacy and safety of Macrolane for female breast enhancement.

Eligibility Criteria

Inclusion Criteria

Female between 25 and 50 years of age with small breasts seeking enhancement of the shape and fullness of the breast

Exclusion Criteria

Unreasonable expectations
Any medical condition that may interfere with the treatment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01308853). 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.