Macrolane VRF30 for Enhancement of Shape & Fullness of Female Breast

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

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.

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01308853` - Macrolane for Enhancement of the Shape and Fullness of the Female Breast	N/A
	Completed	`NCT01609400` - An Extension of CTN 31GB0607 to Evaluate Long Term Safety of NASHA Treatment in the Breast

NCT number	NCT01299532
Study type	Interventional
Source	Galderma R&D
Contact
Status	Completed
Phase	Phase 4
Start date	November 2008
Completion date	October 2013

Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast — COBRA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms