Lip AugmentationNCT00935272

Safety/Efficacy Study of Restylane® in Lip Augmentation

A study testing Restylane® and Non-Treatment in people with Lip Augmentation, run by Medicis Global Service Corporation at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To determine the safety and effectiveness of Restylane® when used for lip augmentation. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Lip Augmentation
What is being tested?: Restylane® and Non-Treatment
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 12 sitesUnited States
Study dates: Jul 2009to Jul 2010
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

Must meet established lip fullness criteria

Who cannot join

Allergic to injectable hyaluronic acid, local topical anesthetics or nerve blocking agents; Conditions/procedures that could interfere with lip fullness evaluations

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

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Chapel Hill, North Carolina, 27517
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Chestnut Hill, Massachusetts, 02467
Study site
Clinton Twp., Michigan, 78038
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Coral Gables, Florida, 33146
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Hunt Valley, Maryland, 21030
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Miami Beach, Florida, 33140
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Mount Kisco, New York, 10549
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New Haven, Connecticut, 06511-5409
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San Diego, California, 92123
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San Francisco, California, 94117
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Santa Monica, California, 90404
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Warren, Michigan, 48088

Other trials in United States

About this study

Official title: A Randomized, Evaluator-Blinded, No-Treatment-Controlled Study of the Effectiveness and Safety of Restylane® in the Augmentation of Soft Tissue Fullness of the Lips

To determine the safety and effectiveness of Restylane® when used for lip augmentation.

Conditions: Lip Augmentation
Being tested: Restylane®, Non-Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Restylane®Device
Restylane® injections in the lips
Non-TreatmentDevice
Non- Treatment

Study groups in NCT00935272
Study group	Role	What they receive
Treatment	Experimental	Restylane® Treatment Receives: Device: Restylane®
Non-Treatment	No intervention	Non-Treatment Arm Receives: Device: Non-Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Response
Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at week 8 as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.
Measured: Baseline and at 8 weeks

Secondary outcomes (1)

Percentage of Participants With a Response
Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at post-baseline time points as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.
Measured: Baseline and at weeks 12, 16, 20 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Jul 2010

First posted9 Jul 2009 (estimated)
Study startJul 2009
Primary completionJun 2010
Study completionJul 2010

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 Lip AugmentationStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00935272
Sponsor's protocol ID: MA-1300-15
Status last verified: Dec 2011
First submitted: 7 Jul 2009
Last updated: 30 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
A Study to Evaluate the Safety and Performance of Dr Korman Laboratories' Hyaluronic Acid Filler 20 mg/mL With Lidocaine for Lip Augmentation
Lip Augmentation
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
Active, not recruiting
Clinical Investigation on Lips Treated With HA-filler
Aesthetic Correction of the Lips
Recruiting
Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
Lips Enhancement, Perioral Wrinkles
Active, not recruitingObservational study
Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
Facial Aging, Skin Rejuvenation

All Lip Augmentation trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Evaluator-Blinded, No-Treatment-Controlled Study of the Effectiveness and Safety of Restylane® in the Augmentation of Soft Tissue Fullness of the Lips
ClinicalTrials.gov ID: NCT00935272
Acronym / sponsor ID: MA-1300-15
Conditions: Lip Augmentation
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Medicis Global Service CorporationIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Jun 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 9 Jul 2009 (estimated)
Results: Posted 30 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine the safety and effectiveness of Restylane® when used for lip augmentation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Treatment	Experimental	Device: Restylane®Restylane® Treatment
Non-Treatment	No intervention	Device: Non-TreatmentNon-Treatment Arm

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Must meet established lip fullness criteria

Key exclusion criteria (1 listed)

Allergic to injectable hyaluronic acid, local topical anesthetics or nerve blocking agents; Conditions/procedures that could interfere with lip fullness evaluations

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®Restylane® injections in the lips	Device	Treatment
Non-TreatmentNon- Treatment	Device	Non-Treatment

Primary outcome

Percentage of Participants With Response
Time frame: Baseline and at 8 weeks
Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at week 8 as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.

1 secondary outcome

Percentage of Participants With a Response
Time frame: Baseline and at weeks 12, 16, 20 and 24

Results and safety

Results posted to the registry on 30 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment With Restylane	135	116
No Treatment	45	39

Primary outcome: Percentage of Participants With Response

Time frame: Baseline and at 8 weeks. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Treatment With Restylane n = 135	No Treatment n = 45
Value	92.6 (86.8 to 96.4)	28.9 (16.4 to 44.3)

Population analysed: Analysis was ITT; Sample size based upon a one-sided Fisher's Exact test with alpha = 0.05; Subjects with a missing Blinded Evaluator assessment as Week 8 were imputed using the hot deck method

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment With Restylane	4 of 135 (3%)	149 of 172 (86.6%)	Not reported
No Treatment	1 of 45 (2.2%)	5 of 45 (11.1%)	Not reported
Second Treatment	0 of 93 (0%)	60 of 93 (64.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lip Augmentation

Recruiting
A Study to Evaluate the Safety and Performance of Dr Korman Laboratories' Hyaluronic Acid Filler 20 mg/mL With Lidocaine for Lip Augmentation
Lip Augmentation
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
Active, not recruiting
Clinical Investigation on Lips Treated With HA-filler
Aesthetic Correction of the Lips
Recruiting
Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
Lips Enhancement, Perioral Wrinkles
Active, not recruitingObservational study
Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
Facial Aging, Skin Rejuvenation

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.

Heather Corey, MBA study chair

Medicis Global Service Corporation

12 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 Non-Treatment in people with Lip Augmentation, run by Medicis Global Service Corporation at 12 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 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 30 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 Jan 2012). 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?

Percentage of Participants With Response (time frame: Baseline and at 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00935272.

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 Jan 2012.