Breast EnhancementNCT01609400
An Extension of CTN 31GB0607 to Evaluate Long Term Safety of NASHA Treatment in the Breast
An observational study of Breast Enhancement, run by Galderma R&D.
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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Breast Enhancement
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Subjects treated in study 31GB0607
Who may be able to join
- subject treated with NASHA-gel in the breasts in study 31GB0607
- signed informed consent
Who cannot join
- no exclusion criteria in this study
About this study
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.
- Conditions
- Breast Enhancement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast enhancement | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate if study product has been completely degraded in the breast 4 years post treatment in study 31GB0607, using MRI
Measured: 4 years
Evaluate if study product has been completely degraded in the breast 6 years post treatment in study 31GB0607, using MRI
Measured: 6 years
Secondary outcomes (6)
Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography.
Measured: 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
Measured: 4 years
Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s)
Measured: 4 years
Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography.
Measured: 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
Measured: 6 years
Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s)
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startDec 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast EnhancementStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Hedén, M.D., Principal investigator, Akademikliniken, Stockholm, SwedenMichael Olenius, M.D., Principal investigator, Proforma Clinic AB, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609400
- Sponsor's protocol ID
- 31GB1103
- Status last verified
- Feb 2015
- First submitted
- 8 May 2012
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension of CTN 31GB0607 to Evaluate Long Term Safety of NASHA Treatment in the Breast
- ClinicalTrials.gov ID
- NCT01609400
- Acronym / sponsor ID
- 31GB1103
- Conditions
- Breast Enhancement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 1 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast enhancement | – | – |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects treated in study 31GB0607
Key inclusion criteria (2 listed)
- subject treated with NASHA-gel in the breasts in study 31GB0607
- signed informed consent
Key exclusion criteria (1 listed)
- no exclusion criteria in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate if study product has been completely degraded in the breast 4 years post treatment in study 31GB0607, using MRI
Time frame: 4 years
Evaluate if study product has been completely degraded in the breast 6 years post treatment in study 31GB0607, using MRI
Time frame: 6 years
6 secondary outcomes
Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography.
Time frame: 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
Time frame: 4 years
Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s)
Time frame: 4 years
Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography.
Time frame: 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
Time frame: 6 years
Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s)
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Hedén, M.D. principal investigator
Akademikliniken, Stockholm, Sweden
Michael Olenius, M.D. principal investigator
Proforma Clinic AB, Stockholm, Sweden
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Enhancement, run by Galderma R&D.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate if study product has been completely degraded in the breast 4 years post treatment in study 31GB0607, using MRI (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.