Nasolabial FoldsNCT00797459
Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds
A study testing Restylane and Restylane-L in people with Nasolabial Folds, run by Medicis Global Service Corporation at 3 sites in United States.
Trial summary
Safety \& tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- Restylane and Restylane-L
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects seeking augmentation therapy for correction of bilateral NLFs
- Same WSRS score at both NLFs (either both Moderate [3] or both Severe [4])
- Subjects willing to give written informed consent to participate in the study
- Women of childbearing potential willing to use an acceptable form of birth control during the study period
Who cannot join
- Active or chronic skin disease, inflammation or related conditions, near or on the NLFs
- Subjects who had undergone procedures based on active dermal response e.g., laser or chemical peeling procedures) within 6 months prior to study entry
- Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
- Permanent implant placed in the NLF area
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dermatology Research Institute LLC
Coral Gables, Florida, 33146
Maryland Laser Skin and Vein Institute
Hunt Valley, Maryland, 21030
The Center for Dermatology, Cosmetic and Laser Surgery
Mount Kisco, New York, 10549
About this study
Official title: A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
Safety \& tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.
Read the detailed description
A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
- Conditions
- Nasolabial Folds
- Being tested
- Restylane and Restylane-L
- Keywords
- Correction of Nasolabial Folds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane and Restylane-LDevice
This is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive.
| Study group | Role | What they receive |
|---|---|---|
| Restylane and Restylane with Lidocaine | Experimental | This is a split-face design injecting both Restylane and Restylane-L injectable gels, administered once. Each subject received Restylane on one side of the face, and Restylane-L on the other. Subjects were blinded to which side of their face received Restylane or Restylane-L. The study was randomized and treatments successive. Receives: Device: Restylane and Restylane-L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Difference in Pain as Measured by a Visual Analogue Scale
No pain is noted at 0 mm and worst pain is noted at 100 mm.
Measured: After Injection on Day of Treatment
Secondary outcomes (1)
Wrinkle Improvement at Day 14
This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.
Measured: 14 days after treatment when compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicis Global Service Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Q-Med Scandinavia, Inc.
- Responsible party
- Sponsor
- Investigators
- David Bank, MD, Principal investigator, The Center for Dermatology, Cosmetic and Laser SurgeryFredric Brandt, MD, Principal investigator, Dermatology Research Institute LLCRobert Weiss, MD, Principal investigator, Maryland Laser Skin and Vein InstituteRon Staugaard, Study director, Medicis Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797459
- Sponsor's protocol ID
- MA-1100-001
- Status last verified
- Aug 2013
- First submitted
- 24 Nov 2008
- Last updated
- 6 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT00797459
- Acronym / sponsor ID
- MA-1100-001
- Conditions
- Nasolabial Folds
- Keywords
- Correction of Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medicis Global Service CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Q-Med Scandinavia, Inc.
- Study start
- Nov 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 25 Nov 2008 (estimated)
- Results
- Posted 21 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety \& tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.
Detailed description
A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restylane and Restylane with Lidocaine | Experimental | Device: Restylane and Restylane-LThis is a split-face design injecting both Restylane and Restylane-L injectable gels, administered once. Each subject received Restylane on one side of the face, and Restylane-L on the other. Subjects were blinded to which side of their face received Restylane or Restylane-L. The study was randomized and treatments successive. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects seeking augmentation therapy for correction of bilateral NLFs
- Same WSRS score at both NLFs (either both Moderate [3] or both Severe [4])
- Subjects willing to give written informed consent to participate in the study
- Women of childbearing potential willing to use an acceptable form of birth control during the study period
Key exclusion criteria (4 listed)
- Active or chronic skin disease, inflammation or related conditions, near or on the NLFs
- Subjects who had undergone procedures based on active dermal response e.g., laser or chemical peeling procedures) within 6 months prior to study entry
- Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
- Permanent implant placed in the NLF area
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 |
|---|---|---|
| Restylane and Restylane-LThis is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive. | Device | Restylane and Restylane with Lidocaine |
Primary outcome
Treatment Difference in Pain as Measured by a Visual Analogue Scale
Time frame: After Injection on Day of Treatment
No pain is noted at 0 mm and worst pain is noted at 100 mm.
1 secondary outcome
Wrinkle Improvement at Day 14
Time frame: 14 days after treatment when compared to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Bank, MD principal investigator
The Center for Dermatology, Cosmetic and Laser Surgery
Fredric Brandt, MD principal investigator
Dermatology Research Institute LLC
Robert Weiss, MD principal investigator
Maryland Laser Skin and Vein Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane and Restylane-L in people with Nasolabial Folds, run by Medicis Global Service Corporation at 3 sites in United States.
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 4 inclusion and 4 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 6 Sep 2013. 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 United States. 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?
Yes. Results are posted in the registry (first posted 21 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Difference in Pain as Measured by a Visual Analogue Scale (time frame: After Injection on Day of Treatment). 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 6 Sep 2013.