Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast (COBRA)

Galderma

Status and phase: Completed; Phase 4

Conditions: Breast Enhancement

Treatments: Device: Macrolane VRF30

Study type: Interventional

Funder types: Industry

Identifiers

NCT01299532

31GB0801

Details and patient eligibility

About

This is an open, multi-center, non comparative study to evaluate the safety and efficacy of Macrolane VRF30 in the female breast. 71 subjects have received initial treatment with a maximum of 120 ml of Macrolane VRF30 per breast. 22 patients have received a re-injection (max 120 ml/breast) of Macrolane nine months after initial treatment. Patients are followed for 24 months after last treatment.

Enrollment: 71 patients

Sex: Female

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients between 25 and 60 years with small breasts seeking enhancement of the shape and fullness of the breast

Exclusion criteria

• Unreasonable expectations as regards the increase in breast volume
• Any medical conditions that may interfere in any way.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

Macrolane VRF30

Experimental group

Treatment:

Device: Macrolane VRF30