An Extension of CTN 31GB0607 to Evaluate Long Term Safety of NASHA

Clinical Trial Summary

The study evaluates degradation of NASHA in breast 4 and 6 years post treatment, long term safety and evaluation if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast. An independent evaluation of the aesthetic changes is also performed.

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01299532` - Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast	Phase 4
	Completed	`NCT01308853` - Macrolane for Enhancement of the Shape and Fullness of the Female Breast	N/A

See also

Status

Clinical Trial

Phase

Completed

NCT01299532 - Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast

Phase 4

Completed

NCT01308853 - Macrolane for Enhancement of the Shape and Fullness of the Female Breast

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

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.

NCT number	NCT01609400
Study type	Observational
Source	Galderma R&D
Contact
Status	Completed
Phase
Start date	December 2011
Completion date	August 2013

An Extension of CTN 31GB0607 to Evaluate Long Term Safety of NASHA Treatment in the Breast

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms