Glabellar RhytidesPhase 3PT-03bNCT00752050

Safety and Efficacy Study of Repeat Treatment With PurTox® Botulinum Toxin Type A for Frown Lines Between the Eyebrows

A Phase 3 study testing Mentor Purified Toxin Botulinum Toxin Type A and Preservative-free Saline in people with Glabellar Rhytides and Frown Lines Between the Eyebrows, run by Mentor Worldwide, LLC at 1 site 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

The overall purpose of this study is to evaluate the safety and effectiveness of repeat treatment of an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines, compared with placebo. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glabellar Rhytides, Frown Lines Between the Eyebrows
What is being tested?: Mentor Purified Toxin Botulinum Toxin Type A and Preservative-free Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 699 participants
Where: 1 siteUnited States
Study dates: Nov 2007to Mar 2009
Phase: Phase 3
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects who are 18 years of age or older (subjects should have an interest in the effacement of glabellar rhytides) with or without previous botulinum Toxin Type A exposure;
In good physical and mental health as determined by the investigator based on medical history, physical examination, and/or clinical laboratory tests;
Noticeable presence of the glabellar rhytides for a period of 6 months or longer;
Score at least a 2 (moderate severity) at baseline screening on the investigator's and subject's assessments (reference photographs provided) at forced frown; and
Capable of understanding and complying with the protocol and must have signed the informed consent document prior to performance of any study-related procedures.

Who cannot join

A history of psychiatric problems that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
A history of autoimmune disease, that, in the opinion of the investigator, might interfere with subject outcomes (e.g., osteoarthritis is not considered an exclusion criteria; however, subjects with dermatomyositis are not permitted to participate in this study);
A history or presence of clinically significant cardiovascular, respiratory, hepatic/biliary, renal, gastrointestinal, endocrinological, or neurological disorders constituting a possible risk factor that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
Inability to substantially efface glabellar lines by manually spreading skin apart;
Eyelid ptosis;
Myasthenia gravis (from medical history or diseases of neurotransmission);

Show all 19Show fewer

Current history of facial nerve paralysis;
Concurrent dermatologic disease of the face in the glabellar area that is deemed by the investigator to make the subject an inappropriate candidate for the study;
Recent flu-like syndrome that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
Neuromuscular disorder that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
Active multisystems disease that, in the investigator's opinion, might influence the outcome measures or the safety of the subject;
Has any condition(s) that in the investigator's opinion would a) warrant exclusion from the study, or b) prevent the subject from completing the study;
Currently receiving aminoglycoside antibiotic therapy, curare-like drugs, quinidine, succinylcholine, polymyxins, anticholinesterases, magnesium sulfate, or lincosamides;
Has taken any investigational drug during the 30 days prior to screening visit;
Have had Botulinum Toxin treatments to the glabellar and/or forehead area during the 6 months prior to screening visit;
Have had dermal filler treatment to glabellar area during the 6 months prior to screening visit;
Female subjects who are pregnant or lactating. Female subjects who are of childbearing potential must have negative urine pregnancy test results prior to enrollment into the study. Such subjects, including peri-menopausal women who have had a menstrual period within one year, must be using appropriate birth control (see protocol/informed consent for description);
Unwilling or unable to comply with the protocol or to cooperate fully with the investigator and site personnel; and
Unable to understand verbal and/or written English or any other language in which a certified translation of the informed consent document is available.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mentor Wordwide, LLC
Santa Barbara, California, 93111

Other trials in United States

About this study

Official title: A Phase 3, Multi-Center Trial to Demonstrate the Safety and Efficacy of Repeat Treatment With PurTox® for the Treatment of Glabellar Rhytides ("Frown Lines")

Read the detailed description

The purpose of this a randomized withdrawal Phase III, multi-center research study is to evaluate the safety and effectiveness of repeat treatment with an intramuscular dose of Mentor Purified Toxin in the reduction of glabellar rhytides (frown lines). Approximately 700 subjects will be enrolled at approximately 12 clinical sites in the U.S.A.

Effectiveness will be determined by the degree of frown line reduction, during maximum forced frown and at rest (neutral expression):

as assessed live by the study doctor,
as assessed live by the subject, and;
as assessed by an independent reviewer based on subject photographs

Frown lines are graded on level of severity based on this scale:

Severity

Minimal (0)
Mild (1)
Moderate (2)
Severe (3)

There are two parts to this study. In the first part, all study participants will receive treatment with an intramuscular injection of 30 Units of Mentor Purified Toxin on two separate occasions (Cycles 1 and 2) no more than 6 months apart. In the second part of the study (Cycle 3), subjects will be randomly assigned to receive either intramuscular injections of 30 Units of Mentor Purified Toxin or placebo (preservative-free saline) and subjects will be followed for 1 month (3:1, PurTox : placebo).

Each subject will receive five intramuscular injections for a total of 0.5 mL of study drug in the glabellar area, during each treatment visit. Participation takes place over a maximum of 14 months, including Part 1 (Cycle 1 and 2) and Part 2 (Cycle 3). The number of clinic visits will vary from person to person depending upon the subject's response to the study drug, but will range from approximately 9 to 19 clinic visits. There will also be up to 4 telephone follow-up contacts.

Conditions: Glabellar Rhytides, Frown Lines Between the Eyebrows
Being tested: Mentor Purified Toxin Botulinum Toxin Type A, Preservative-free Saline
Keywords: Botulinum Toxin Type A, Botulinum Toxin, Glabellar Rhytides, Rhytides, Frown Lines, Neuromuscular Agents, Neurotoxin, Forehead, Eyebrow, Wrinkle

What participants receive

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

Mentor Purified Toxin Botulinum Toxin Type ADrug
Also called Botulinum Toxin Type A, Botulinum Toxin
For Part II, subjects in this arm will receive five 0.1 mL intramuscular injections at the Day 0 Treatment Visit: two in each corrugator and one in the procerus muscle. The total treatment dose (sum of the five injections) to be administered will be 30 U of the Active Comparator Mentor Purified Toxin.
Preservative-free SalineDrug
Also called Saline
For Part II, subjects in this arm will receive five 0.1 mL intramuscular injections at the Day 0 Treatment Visit: two in each corrugator and one in the procerus muscle. The total treatment dose (sum of the five injections) to be administered will be 0.5 mL of the placebo (preservative-free saline).

Study groups in NCT00752050
Study group	Role	What they receive
1	Active comparator	Mentor Purified Toxin Botulinum Toxin Type A - Part II ONLY. (Part I is Single Group and all participants receive active drug and are not randomized) Receives: Drug: Mentor Purified Toxin Botulinum Toxin Type A
2	Placebo comparator	Preservative-free Saline - Part II ONLY. (Part I is Single Group and all participants receive active drug and are not randomized) Receives: Drug: Preservative-free Saline

What is being measured

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

Change in assessments of severity of glabellar rhytide by the investigator and the subject at maximum frown as a single composite effectiveness endpoint.
Measured: Day 30 post randomization
Measurement of the incidences of treatment-emergent adverse events, serious treatment-emergent adverse events, treatment-emergent laboratory abnormalities, and vital signs.
Measured: Throughout

Secondary outcomes (3)

Change in assessments of severity of glabellar rhytide by the investigator and the subject at maximum frown.
Measured: Day 30 post-injection
Change in assessments of severity of glabellar rhytide by the investigator and the subject at rest.
Measured: Day 30 post randomization
Change in assessments of severity of glabellar rhytide by independent reviewers based on the photographs of the subject's glabellar lines at maximum frown.
Measured: Baseline and Day 30 post randomization

Timeline

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

Nov 2007Mar 2009

First posted15 Sep 2008 (estimated)
Study startNov 2007
Primary completionFeb 2009
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Glabellar RhytidesStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 699 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00752050
Sponsor's protocol ID: PT-03b
Acronym: PT-03b
Status last verified: Sep 2011
First submitted: 11 Sep 2008
Last updated: 12 Sep 2011
Results posted: No
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

Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 in Adult Chinese Participants With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 4
Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides
Wrinkle, Glabellar Frown Lines
Active, not recruitingEarly Phase 1
A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles
Wrinkles

All Glabellar Rhytides trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multi-Center Trial to Demonstrate the Safety and Efficacy of Repeat Treatment With PurTox® for the Treatment of Glabellar Rhytides ("Frown Lines")
ClinicalTrials.gov ID: NCT00752050
Acronym / sponsor ID: PT-03b / PT-03b
Conditions: Glabellar Rhytides, Frown Lines Between the Eyebrows
Keywords: Botulinum Toxin Type A, Botulinum Toxin, Glabellar Rhytides, Rhytides, Frown Lines, Neuromuscular Agents, Neurotoxin, Forehead
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 699 participants (actual)
Lead sponsor: Mentor Worldwide, LLCIndustry (pharma, biotech, devices)
Collaborators: Synteract, Inc.
Study start: Nov 2007
Primary completion: Feb 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 15 Sep 2008 (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.

Detailed description

Effectiveness will be determined by the degree of frown line reduction, during maximum forced frown and at rest (neutral expression):

as assessed live by the study doctor,
as assessed live by the subject, and;
as assessed by an independent reviewer based on subject photographs

Frown lines are graded on level of severity based on this scale:

Severity

Minimal (0)
Mild (1)
Moderate (2)
Severe (3)

Study design

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

Arm	Type	Receives
1	Active comparator	Drug: Mentor Purified Toxin Botulinum Toxin Type AMentor Purified Toxin Botulinum Toxin Type A - Part II ONLY. (Part I is Single Group and all participants receive active drug and are not randomized)
2	Placebo comparator	Drug: Preservative-free SalinePreservative-free Saline - Part II ONLY. (Part I is Single Group and all participants receive active drug and are not randomized)

Who may qualify

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

Key inclusion criteria (5 listed)

Male or female subjects who are 18 years of age or older (subjects should have an interest in the effacement of glabellar rhytides) with or without previous botulinum Toxin Type A exposure;
In good physical and mental health as determined by the investigator based on medical history, physical examination, and/or clinical laboratory tests;
Noticeable presence of the glabellar rhytides for a period of 6 months or longer;
Score at least a 2 (moderate severity) at baseline screening on the investigator's and subject's assessments (reference photographs provided) at forced frown; and
Capable of understanding and complying with the protocol and must have signed the informed consent document prior to performance of any study-related procedures.

Key exclusion criteria (19 listed)

A history of psychiatric problems that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
A history of autoimmune disease, that, in the opinion of the investigator, might interfere with subject outcomes (e.g., osteoarthritis is not considered an exclusion criteria; however, subjects with dermatomyositis are not permitted to participate in this study);
A history or presence of clinically significant cardiovascular, respiratory, hepatic/biliary, renal, gastrointestinal, endocrinological, or neurological disorders constituting a possible risk factor that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
Inability to substantially efface glabellar lines by manually spreading skin apart;
Eyelid ptosis;

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
Mentor Purified Toxin Botulinum Toxin Type AAlso: Botulinum Toxin Type A, Botulinum ToxinFor Part II, subjects in this arm will receive five 0.1 mL intramuscular injections at the Day 0 Treatment Visit: two in each corrugator and one in the procerus muscle. The total treatment dose (sum of the five injections) to be administered will be 30 U of the Active Comparator Mentor Purified Toxin.	Drug	1
Preservative-free SalineAlso: SalineFor Part II, subjects in this arm will receive five 0.1 mL intramuscular injections at the Day 0 Treatment Visit: two in each corrugator and one in the procerus muscle. The total treatment dose (sum of the five injections) to be administered will be 0.5 mL of the placebo (preservative-free saline).	Drug	2

Primary outcome

Change in assessments of severity of glabellar rhytide by the investigator and the subject at maximum frown as a single composite effectiveness endpoint.
Time frame: Day 30 post randomization
Measurement of the incidences of treatment-emergent adverse events, serious treatment-emergent adverse events, treatment-emergent laboratory abnormalities, and vital signs.
Time frame: Throughout

3 secondary outcomes

Change in assessments of severity of glabellar rhytide by the investigator and the subject at maximum frown.
Time frame: Day 30 post-injection
Change in assessments of severity of glabellar rhytide by the investigator and the subject at rest.
Time frame: Day 30 post randomization
Change in assessments of severity of glabellar rhytide by independent reviewers based on the photographs of the subject's glabellar lines at maximum frown.
Time frame: Baseline and Day 30 post randomization

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 12 Sep 2011.

Related trials for Glabellar Rhytides

Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 in Adult Chinese Participants With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 4
Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides
Wrinkle, Glabellar Frown Lines
Active, not recruitingEarly Phase 1
A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles
Wrinkles

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.

Corey Maas, MD study director

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 19 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 12 Sep 2011. 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 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Change in assessments of severity of glabellar rhytide by the investigator and the subject at maximum frown as a single composite effectiveness endpoint. (time frame: Day 30 post randomization). The study lists 2 primary outcomes in all. 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 NCT00752050.

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 12 Sep 2011.