Glabellar RhytidesPhase 3PT-03aNCT00752297
Safety and Efficacy Study of PurTox® Botulinum Toxin Type A to Treat Frown Lines Between the Eyebrows
A Phase 3 study testing Preservative-free Saline and Mentor Purified Toxin in people with Glabellar Rhytides, run by Mentor Worldwide, LLC at 1 site in United States.
Trial summary
The overall purpose of this study is to evaluate the safety and effectiveness 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
- What is being tested?
- Preservative-free Saline and Mentor Purified Toxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to May 2008
- 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
- History of psychiatric problems that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
- 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);
- 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 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 use 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 Worldwide, LLC
Santa Barbara, California, 93111
About this study
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Single-Dose Pivotal Trial to Demonstrate the Safety and Efficacy of PurTox® for the Treatment of Glabellar Rhytides ("Frown Lines")
The overall purpose of this study is to evaluate the safety and effectiveness of an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines, compared with placebo.
Read the detailed description
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, two-arm, single-dose study to evaluate the safety and efficacy of Mentor Purified Toxin for the treatment of glabellar rhytides. Approximately 400 subjects will be enrolled in the study. The subjects will be randomized 3:1 (300 Mentor Purified Toxin: 100 placebo) to receive either intramuscular injections of 30 U of Mentor Purified Toxin or placebo (preservative-free saline).
Injected subjects will be observed for 180 days of post treatment follow-up. Follow-up clinic visits are scheduled for post treatment days 3, 7, 14, 30, 60, 90, 120, 150, and 180.
The study will be conducted at up to ten clinical sites. Safety, tolerability, clinical efficacy, onset and duration of effect will be studied during the study
The effectiveness of Mentor Purified Toxin 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)
- Conditions
- Glabellar Rhytides
- Being tested
- Preservative-free Saline, Mentor Purified Toxin
- 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.
Preservative-free SalineDrug
Also called Saline
Subjects 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).
Mentor Purified ToxinDrug
Also called Arms: 1, Other Names:, Mentor Purified Toxin Botulinum Toxin Type A, Botulinum Toxin Type A
All subjects will receive five 0.1 mL intramuscular injections (two in each corrugator and one in the procerus muscle) at each Treatment Visit. The total treatment dose (sum of the five injections) to be administered will be 30 U of PurTox. Subjects will have many Treatment Visits throughout the course of the three-year study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Mentor Purified Toxin Botulinum Toxin Type A Receives: Drug: Mentor Purified Toxin |
| 2 | Placebo comparator | Preservative-free Saline Receives: Drug: Preservative-free Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of glabellar rhytide reduction assessed by the investigator and the subject at maximum frown as a single composite effectiveness endpoint.
Measured: Day 30 post-injection
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 (4)
Degree of glabellar rhytide reduction assessed by the investigator and the subject at maximum frown.
Measured: Days 3, 7 and 30 post-injection
Degree of glabellar rhytide reduction assessed by the investigator and the subject at rest.
Measured: Day 30 Post-injection
Degree of glabellar rhytide reduction assessed by independent reviewers based on photographs of the subject's glabellar lines at maximum frown.
Measured: Baseline and Day 30 post-injection
Explore the global satisfaction of the subject with the treatment.
Measured: Day 30 post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startJun 2007
- Primary completionMay 2008
- Study completionMay 2008
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
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mentor Worldwide, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Corey Maas, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752297
- Sponsor's protocol ID
- PT-03a
- Acronym
- PT-03a
- Status last verified
- Sep 2011
- First submitted
- 10 Sep 2008
- Last updated
- 12 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
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, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Single-Dose Pivotal Trial to Demonstrate the Safety and Efficacy of PurTox® for the Treatment of Glabellar Rhytides ("Frown Lines")
- ClinicalTrials.gov ID
- NCT00752297
- Acronym / sponsor ID
- PT-03a / PT-03a
- Conditions
- Glabellar Rhytides
- 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
- 402 participants (actual)
- Lead sponsor
- Mentor Worldwide, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Jun 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (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.
The overall purpose of this study is to evaluate the safety and effectiveness of an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines, compared with placebo.
Detailed description
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, two-arm, single-dose study to evaluate the safety and efficacy of Mentor Purified Toxin for the treatment of glabellar rhytides. Approximately 400 subjects will be enrolled in the study. The subjects will be randomized 3:1 (300 Mentor Purified Toxin: 100 placebo) to receive either intramuscular injections of 30 U of Mentor Purified Toxin or placebo (preservative-free saline).
Injected subjects will be observed for 180 days of post treatment follow-up. Follow-up clinic visits are scheduled for post treatment days 3, 7, 14, 30, 60, 90, 120, 150, and 180.
The study will be conducted at up to ten clinical sites. Safety, tolerability, clinical efficacy, onset and duration of effect will be studied during the study
The effectiveness of Mentor Purified Toxin 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 ToxinMentor Purified Toxin Botulinum Toxin Type A |
| 2 | Placebo comparator | Drug: Preservative-free SalinePreservative-free Saline |
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)
- History of psychiatric problems that, in the investigator's opinion, is severe enough potentially to interfere with subject outcomes;
- 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);
- 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 |
|---|---|---|
| Preservative-free SalineAlso: SalineSubjects 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 |
| Mentor Purified ToxinAlso: Arms: 1, Other Names:, Mentor Purified Toxin Botulinum Toxin Type A, Botulinum Toxin Type AAll subjects will receive five 0.1 mL intramuscular injections (two in each corrugator and one in the procerus muscle) at each Treatment Visit. The total treatment dose (sum of the five injections) to be administered will be 30 U of PurTox. Subjects will have many Treatment Visits throughout the course of the three-year study. | Drug | 1 |
Primary outcome
Degree of glabellar rhytide reduction assessed by the investigator and the subject at maximum frown as a single composite effectiveness endpoint.
Time frame: Day 30 post-injection
Measurement of the incidences of treatment-emergent adverse events, serious treatment-emergent adverse events, treatment-emergent laboratory abnormalities, and vital signs.
Time frame: Throughout
4 secondary outcomes
Degree of glabellar rhytide reduction assessed by the investigator and the subject at maximum frown.
Time frame: Days 3, 7 and 30 post-injection
Degree of glabellar rhytide reduction assessed by the investigator and the subject at rest.
Time frame: Day 30 Post-injection
Degree of glabellar rhytide reduction assessed by independent reviewers based on photographs of the subject's glabellar lines at maximum frown.
Time frame: Baseline and Day 30 post-injection
Explore the global satisfaction of the subject with the treatment.
Time frame: Day 30 post-injection
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.
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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.
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?
A Phase 3 study testing Preservative-free Saline and Mentor Purified Toxin in people with Glabellar Rhytides, run by Mentor Worldwide, LLC at 1 site 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 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?
Degree of glabellar rhytide reduction assessed by the investigator and the subject at maximum frown as a single composite effectiveness endpoint. (time frame: Day 30 post-injection). 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?
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.