Nasolabial FoldsNCT00823069
Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose
A study testing Perlane and Perlane-L in people with Nasolabial Folds, run by Medicis Global Service Corporation at 3 sites in United States.
Trial summary
Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- Perlane and Perlane-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
- Jan 2009to Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Same Wrinkle Severity Rating Scale score at both Nasolabial Folds (either both Moderate [3] or both Severe [4])
Who cannot join
- Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds
- 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 Nasolabial Fold area
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Coral Gables, Florida
Study site
Hunt Valley, Maryland
Study site
Mount Cisco, New York
About this study
Official title: A Randomized, Double-Blind Study Comparing Safety and Tolerability of Perlane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose.
Read the detailed description
This is a split-face design. All 60 subjects receive Perlane on one side of their face, and Perlane-L on the other. Subjects and the investigator is blinded to which side of face receives which product. These are one time injections.
- Conditions
- Nasolabial Folds
- Being tested
- Perlane and Perlane-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.
Perlane and Perlane-LDevice
Also called Each subject received both Perlane-L and Perlane.
This is a split face design and each subject received both Perlane-L and Perlane. Treatments were blinded, randomized, and successive.
| Study group | Role | What they receive |
|---|---|---|
| Perlane and Perlane-L | Other | This is a split-face design injecting both Perlane and Perlane-L injectable gels, administered once. Each subject received Perlane-L on one side of the face, and Perlane on the other. Subjects were blinded to which side of their face receive Perlane or Perlane-L. The study was randomized and treatments successive. Receives: Device: Perlane and Perlane-L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm
Measured: After Injection on Day of Treatment
Secondary outcomes (1)
Number of Subjects Showing 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 posted15 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionApr 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicis Global Service Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Q-Med Scandinavia, Inc.
- Investigators
- Mary Sanstead, Study chair, Medicis Global Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823069
- Sponsor's protocol ID
- MA-1400-03
- Status last verified
- Nov 2010
- First submitted
- 14 Jan 2009
- Last updated
- 30 Nov 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. 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 Perlane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT00823069
- Acronym / sponsor ID
- MA-1400-03
- 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
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Posted 30 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose.
Detailed description
This is a split-face design. All 60 subjects receive Perlane on one side of their face, and Perlane-L on the other. Subjects and the investigator is blinded to which side of face receives which product. These are one time injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perlane and Perlane-L | Other | Device: Perlane and Perlane-LThis is a split-face design injecting both Perlane and Perlane-L injectable gels, administered once. Each subject received Perlane-L on one side of the face, and Perlane on the other. Subjects were blinded to which side of their face receive Perlane or Perlane-L. The study was randomized and treatments successive. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Same Wrinkle Severity Rating Scale score at both Nasolabial Folds (either both Moderate [3] or both Severe [4])
Key exclusion criteria (4 listed)
- Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds
- 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 Nasolabial Fold 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 |
|---|---|---|
| Perlane and Perlane-LAlso: Each subject received both Perlane-L and Perlane.This is a split face design and each subject received both Perlane-L and Perlane. Treatments were blinded, randomized, and successive. | Device | Perlane and Perlane-L |
Primary outcome
Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm
Time frame: After Injection on Day of Treatment
1 secondary outcome
Number of Subjects Showing 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 30 Nov 2010.
- 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.
Mary Sanstead study chair
Medicis Global Pharmaceutical
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perlane and Perlane-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 1 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 30 Nov 2010. 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 30 Nov 2010). 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 VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm (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 30 Nov 2010.