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

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.

Study Overview

• Status: Completed
• Conditions: Breast Enhancement

• Study Type: Observational
• Enrollment (Actual): 11

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Subjects treated in study 31GB0607

Description

Inclusion Criteria:

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

Exclusion Criteria:

• no exclusion criteria in this study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Breast enhancement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate if study product has been completely degraded in the breast 4 years post treatment in study 31GB0607, using MRI	4 years
Evaluate if study product has been completely degraded in the breast 6 years post treatment in study 31GB0607, using MRI	6 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography.	4 years
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
Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s)	4 years
Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography.	6 years
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
Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s)	6 years

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Per Hedén, M.D., Akademikliniken, Stockholm, Sweden; Principal Investigator: Michael Olenius, M.D., Proforma Clinic AB, Stockholm, Sweden

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: May 8, 2012
• First Submitted That Met QC Criteria: May 30, 2012
• First Posted (Estimate): June 1, 2012

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 31GB1103