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

Breast Enhancement Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609400
• Other study ID #: 31GB1103
• Status: Completed
• Start date: December 2011
• Est. completion date: August 2013

Study information

• Verified date: February 2015
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

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

• signed informed consent

Exclusion Criteria:

• no exclusion criteria in this study

Related Conditions & MeSH terms

• Breast Enhancement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate if study product has been completely degraded in the breast 4 years post treatment in study 31GB0607, using MRI		4 years
Primary	Evaluate if study product has been completely degraded in the breast 6 years post treatment in study 31GB0607, using MRI		6 years
Secondary	Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography.		4 years
Secondary	Perform an independent evaluation of aesthetic changes in the treated breasts taking into consideration the aging of the subject, using pre- and post-treatment photos		4 years
Secondary	Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s)		4 years
Secondary	Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography.		6 years
Secondary	Perform an independent evaluation of aesthetic changes in the treated breasts taking into consideration the aging of the subject, using pre- and post-treatment photos		6 years
Secondary	Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s)		6 years