Nasolabial FoldsPhase 4NCT00429520
Hyaluronic Acid Filler IMD1 Basic for Correction of Nasolabial Folds
A Phase 4 study testing Hyaluronic acid filler/IMD1 basic in people with Nasolabial Folds, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
Trial summary
Volunteers receive one injection IMD1 basic of correction of nasolabial folds and are followed-up for up to 36 weeks. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- Hyaluronic acid filler/IMD1 basic
- How many people
- 114 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2005to Dec 2006
- Phase
- Phase 4
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- main inclusion criteria: severity rating scale grade 3 or 4
Who cannot join
- main exclusion criterion: other nasolabial fold corrections within 6 months prior to study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multicentre, Not Controlled Clinical Study to Investigate Efficacy and Tolerability of the Hyaluronic Acid Filler IMD1 Basic After Single Bilateral Injection for Correction of Nasolabial Folds (NLF)
Volunteers receive one injection IMD1 basic of correction of nasolabial folds and are followed-up for up to 36 weeks.
- Conditions
- Nasolabial Folds
- Being tested
- Hyaluronic acid filler/IMD1 basic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid filler/IMD1 basicDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity rating scale assessed by independent rater
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startDec 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johannes Reinmüller, MD, Principal investigator, Klinik am Sonnenberg, Wiesbaden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429520
- Sponsor's protocol ID
- MRZ 90026-0423/1
- Status last verified
- Feb 2008
- First submitted
- 30 Jan 2007
- Last updated
- 7 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre, Not Controlled Clinical Study to Investigate Efficacy and Tolerability of the Hyaluronic Acid Filler IMD1 Basic After Single Bilateral Injection for Correction of Nasolabial Folds (NLF)
- ClinicalTrials.gov ID
- NCT00429520
- Acronym / sponsor ID
- MRZ 90026-0423/1
- Conditions
- Nasolabial Folds
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Dec 2006
- First posted
- 31 Jan 2007 (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.
Volunteers receive one injection IMD1 basic of correction of nasolabial folds and are followed-up for up to 36 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- main inclusion criteria: severity rating scale grade 3 or 4
Key exclusion criteria (1 listed)
- main exclusion criterion: other nasolabial fold corrections within 6 months prior to study entry
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 |
|---|---|---|
| Hyaluronic acid filler/IMD1 basic | Drug | – |
Primary outcome
Severity rating scale assessed by independent rater
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 7 Feb 2008.
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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.
Johannes Reinmüller, MD principal investigator
Klinik am Sonnenberg, Wiesbaden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic acid filler/IMD1 basic in people with Nasolabial Folds, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
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 1 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 7 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Severity rating scale assessed by independent rater. 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 7 Feb 2008.