Facial WrinklesNCT00288470
A Double-blinded Evaluation of Safety and Efficacy of Hylaform and Hylaform Plus Compared to Zyplast.
A study testing Hylaform, Hylaform Plus (hylan B gel) in people with Facial Wrinkles, run by Genzyme, a Sanofi Company.
Trial summary
A clinical study to investigate the safety and efficacy of Hylaform and Hylaform Plus for correction of facial wrinkles. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Facial Wrinkles
- What is being tested?
- Hylaform, Hylaform Plus (hylan B gel)
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 2002to Aug 2003
- 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 30 to 55 years
- All sexes
- Adult
Who may be able to join
- bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale
Who cannot join
- pregnant/lactating women
- patients who previously received permanent facial implants or using ovet-the-counter products
About this study
A clinical study to investigate the safety and efficacy of Hylaform and Hylaform Plus for correction of facial wrinkles.
- Conditions
- Facial Wrinkles
- Being tested
- Hylaform, Hylaform Plus (hylan B gel)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hylaform, Hylaform Plus (hylan B gel)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority as compared to standard of care as assigned by blinded reviewer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startJun 2002
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial WrinklesStudies 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
- Treatment
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288470
- Sponsor's protocol ID
- HYLA-001-01
- Status last verified
- Mar 2015
- First submitted
- 7 Feb 2006
- Last updated
- 18 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded Evaluation of Safety and Efficacy of Hylaform and Hylaform Plus Compared to Zyplast.
- ClinicalTrials.gov ID
- NCT00288470
- Acronym / sponsor ID
- HYLA-001-01
- Conditions
- Facial Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Study completion
- Aug 2003
- First posted
- 8 Feb 2006 (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.
A clinical study to investigate the safety and efficacy of Hylaform and Hylaform Plus for correction of facial wrinkles.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (1 listed)
- bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale
Key exclusion criteria (2 listed)
- pregnant/lactating women
- patients who previously received permanent facial implants or using ovet-the-counter products
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 |
|---|---|---|
| Hylaform, Hylaform Plus (hylan B gel) | Device | – |
Primary outcome
Non-inferiority as compared to standard of care as assigned by blinded reviewer.
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 18 Mar 2015.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
Questions about this trial
What is this clinical trial studying?
A study testing Hylaform, Hylaform Plus (hylan B gel) in people with Facial Wrinkles, run by Genzyme, a Sanofi Company.
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 2 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 18 Mar 2015. 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?
Non-inferiority as compared to standard of care as assigned by blinded reviewer.. 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 18 Mar 2015.