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

Galderma

Status: Completed

Conditions: Breast Enhancement

Study type: Observational

Funder types: Industry

Identifiers

NCT01609400

31GB1103

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subject treated with NASHA-gel in the breasts in study 31GB0607
• signed informed consent

Exclusion criteria

• no exclusion criteria in this study

Trial design

11 participants in 1 patient group

Breast enhancement