Facial LipoatrophyFLASH 1NCT03050723
Safety and Performance of Princess® FILLER for the Treatment of Facial Lipoatrophy, Asymmetry or Scars
A study testing Princess® FILLER in people with Facial Lipoatrophy and Morphological Asymmetry of the Face, run by Croma-Pharma GmbH at 3 sites in Austria.
Trial summary
In this study, eligible patients with the medical indications (facial lipoatrophy, morphological asymmetry of the face, or debilitating scars) will be treated with Princess® FILLER, and then will return for follow-up assessments 2, 4 and 24 weeks after the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Lipoatrophy, Morphological Asymmetry of the Face, Debilitating Scars
- What is being tested?
- Princess® FILLER
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesAustria
- Study dates
- 20 Nov 2016to 16 Jan 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 years of age or older.
- Presence of a defect, which in the opinion of the Investigator can be corrected by a dermal filler, and is caused by: ° Facial lipoatrophy of moderate severity, or
- Morphological asymmetry of the face, or
- One or more debilitating scars on the face.
- Willingness to abstain from any cosmetic or surgical procedures in the treatment area for the duration of the clinical investigation.
- Willingness to take part in the clinical investigation as evidenced by a personally signed informed consent.
Who cannot join
- Pregnancy, breastfeeding, or unwillingness to use contraception throughout the clinical investigation (for women of child-bearing potential only).
- History of allergic reaction or hypersensitivity to hyaluronic acid.
- History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy.
- Presence of silicone implant or other non-absorbable tissue filler in the area targeted for intervention, or pre-treatment with any hyaluronic acid filler within the last 6 months.
- Presence of infectious, inflammatory, or proliferative lesions in the area targeted for intervention.
- Treatment with anticoagulant or antiplatelet drugs
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- Any disease or condition which, in the Investigator's opinion, represents a safety risk for participation in the study
- Current participation in another clinical trial, or previous treatment with any investigational drug/device within 30 days prior to enrolment
- Institutionalized persons with legally limited civil rights
Trial locations and contacts
3 sites in 1 country.
Austria3 sites
Medical University Graz
Graz
MÄZ WIEN (Medizinisch Ästhetisches Zentrum Wien)
Vienna
Ordination Dr. Benjamin Gehl
Vienna
About this study
Official title: A Prospective, Open-label, Non-comparative, Multicentre, Post-market Clinical Follow-up Study of the Princess® FILLER Performance and Safety for Correction of Facial Lipoatrophy, Morphological Asymmetry of the Face, or Debilitating Scars
In this study, eligible patients with the medical indications (facial lipoatrophy, morphological asymmetry of the face, or debilitating scars) will be treated with Princess® FILLER, and then will return for follow-up assessments 2, 4 and 24 weeks after the treatment. A touch-up treatment may be done 2 weeks after the treatment.
- Being tested
- Princess® FILLER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Princess® FILLERDevice
Princess® FILLER injections up to 10 ml applied to the eligible subjects at the baseline visit, and the touch-up visit, if applicable.
| Study group | Role | What they receive |
|---|---|---|
| Princess® FILLER | Other | Not described Receives: Device: Princess® FILLER |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-point scale for clinical response
The proportion of patients with successful treatment outcome at the Week 4 visit based on the Investigator's opinion, where success is defined as excellent, good, or moderate correction of the defect
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start20 Nov 2016
- Primary completion17 Jul 2017
- Study completion16 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial LipoatrophyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Princess® FILLER
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daisy Kopera, Prof., Principal investigator, Medical University Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050723
- Sponsor's protocol ID
- CPH-401-201259
- Acronym
- FLASH 1
- Status last verified
- Dec 2024
- First submitted
- 9 Feb 2017
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Non-comparative, Multicentre, Post-market Clinical Follow-up Study of the Princess® FILLER Performance and Safety for Correction of Facial Lipoatrophy, Morphological Asymmetry of the Face, or Debilitating Scars
- ClinicalTrials.gov ID
- NCT03050723
- Acronym / sponsor ID
- FLASH 1 / CPH-401-201259
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Croma-Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2016 (actual)
- Primary completion
- 17 Jul 2017 (actual)
- Study completion
- 16 Jan 2018 (actual)
- First posted
- 13 Feb 2017 (actual)
- 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.
In this study, eligible patients with the medical indications (facial lipoatrophy, morphological asymmetry of the face, or debilitating scars) will be treated with Princess® FILLER, and then will return for follow-up assessments 2, 4 and 24 weeks after the treatment. A touch-up treatment may be done 2 weeks after the treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Princess® FILLER
| Arm | Type | Receives |
|---|---|---|
| Princess® FILLER | Other | Device: Princess® FILLER |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female 18 years of age or older.
- Presence of a defect, which in the opinion of the Investigator can be corrected by a dermal filler, and is caused by: ° Facial lipoatrophy of moderate severity, or
- Willingness to abstain from any cosmetic or surgical procedures in the treatment area for the duration of the clinical investigation.
- Willingness to take part in the clinical investigation as evidenced by a personally signed informed consent.
Key exclusion criteria (9 listed)
- Pregnancy, breastfeeding, or unwillingness to use contraception throughout the clinical investigation (for women of child-bearing potential only).
- History of allergic reaction or hypersensitivity to hyaluronic acid.
- History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy.
- Presence of silicone implant or other non-absorbable tissue filler in the area targeted for intervention, or pre-treatment with any hyaluronic acid filler within the last 6 months.
- Presence of infectious, inflammatory, or proliferative lesions in the area targeted for intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Princess® FILLERPrincess® FILLER injections up to 10 ml applied to the eligible subjects at the baseline visit, and the touch-up visit, if applicable. | Device | Princess® FILLER |
Primary outcome
6-point scale for clinical response
Time frame: Week 4
The proportion of patients with successful treatment outcome at the Week 4 visit based on the Investigator's opinion, where success is defined as excellent, good, or moderate correction of the defect
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 9 Dec 2024.
- Individual participant dataSharing planned: No
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.
Daisy Kopera, Prof. principal investigator
Medical University Graz, Austria
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Princess® FILLER in people with Facial Lipoatrophy and Morphological Asymmetry of the Face, run by Croma-Pharma GmbH at 3 sites in Austria.
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 6 inclusion and 9 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 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
6-point scale for clinical response (time frame: Week 4). 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 9 Dec 2024.