A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106

Not Applicable

Completed

• Conditions: Breast Augmentation
• Interventions: Radiation: Radiologial breast examination

• Registration Number: NCT01146275
• Lead Sponsor: Galderma R&D

Brief Summary

Several subjects included in a Pilot study (CTN 31GB0106) during 2002-2003 still had Macrolane deposits in the breast when the last study visit was performed. An additional follow up visit is planned to follow duration and safety of the former formulation of Macrolane that was used in the Pilot study (CTN 31GB0106).

Detailed Description

All subjects included in a Pilot study between 2002-2003 (CTN 31GB0106) are offered to take part in a seven year safety follow up after the initial injection of the former formulation of Macrolane into the breasts. The study will not involve any additional treatments.

The follow up will include relevant medical history, weight, breast examination, ultrasound and mammography to determine if there are/have been any safety issues since the final study visit in the Pilot study (CTN 31GB0106), as well as a comprehensive MRI investigation to assess the breast structure and determine if there are still deposits of Macrolane in the breast.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2013-11
• Results First Submitted: 2013-11-29
• Results First Submitted QC: 2013-11-29
• Results First Posted: 2014-01-16
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

Inclusion Criteria

• Participant in 31GB0601

Exclusion Criteria

• There are no exclusion citeria in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants in the Pilot study 31GB0601	Radiologial breast examination	This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane for breast augmentation. Radiological breast examinations - MRI of breast, mammography and ultrasound of breast

Primary Outcome Measures

Name	Time	Method
To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation	7 years +/- 6months post treatment	The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment.
To Evaluate the Long Term Safety of Macrolane in Breast Enhancement	7 years +/- 6 months post treatment	To evaluate the long term safety of Macrolane in breast enhancement, using relevant medical history, breast examination, mammography and ultrasound as well as a comprehensive MRI investigation.; Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation

Trial Locations

Locations (4)

Sophiahemmet; 🇸🇪 Stockholm, Sweden

Akademikliniken Öresund; 🇸🇪 Malmö, Sweden

Akademikliniken; 🇸🇪 Stockholm, Sweden

ProForma Clinic; 🇸🇪 Stockholm, Sweden