Glabellar RhytidesPhase 3PT-03cNCT00752258
A Long-Term Safety Study of Repeat Treatment With PurTox® for Frown Lines Between the Eyebrows
A Phase 3 study testing Mentor Purified Toxin Botulinum Toxin Type A 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 long-term safety of repeat treatment with an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines. 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?
- Mentor Purified Toxin Botulinum Toxin Type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to May 2011
- 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 with 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 criterion; 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, endocrine, 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 or diseases of neurotransmission (from medical history);
Show all 18Show 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 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; or
- 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 III, Multi-Center, Long-Term, Repeat-Treatment, Open-Label, Single-Arm Trial to Demonstrate the Safety of Repeat Treatment With PurTox® for the Treatment of Glabellar Rhytides ("Frown Lines")
The overall purpose of this study is to evaluate the long-term safety of repeat treatment with an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines.
Read the detailed description
This is a Phase III, multi-center, open-label study to evaluate the long-term safety of repeat treatment with PurTox for the treatment of glabellar rhytides. Up to 576 patients will be enrolled at 12 sites in the U.S.A. and some of these patients may have participated in Mentor Purified Toxin Phase I, II and IIIa studies. Safety and tolerability of the repeat treatment with Mentor Purified Toxin will be examined during the study.
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)
All subjects meeting the study eligibility criteria will be treated with 30 U of Mentor Purified Toxin. Following the treatment, follow-up assessments are scheduled as follows: telephone safety assessments on post-treatment Days 7 and 14, a clinic visit on post-treatment Day 30, and a telephone safety assessment on post-treatment Day 60 and monthly thereafter until re-treatment.
A subject will be re-treated when he/she attains grade 2 (Moderate) or 3 (Severe) in the investigator's and subject's ratings of the severity of glabellar rhytides at maximum frown on a 4-point categorical scale, but not earlier than 90 days following the prior treatment. The subject will call the site when he/she rates the glabellar rhytides as grade 2 or 3 in severity to schedule an appointment for re-evaluation and possible re-treatment. The appointment must occur within 2 weeks of the subject's call but not earlier than 90 days post the previous injection. If at the clinic visit the subject's glabellar rhytides are graded by the investigator as grade 2 or 3 in severity and other eligibility criteria are met (e.g., negative urine pregnancy test in female subjects of childbearing potential), the subject will be re-treated. If a subject is eligible for re-treatment on or before 90 days post the previous injection, he/she will receive treatment of Mentor Purified Toxin on or after 90 days. If a subject is not eligible for re-treatment at 90 days, he/she can return to the clinic monthly until attaining grade 2 (Moderate) or 3 (Severe) in the investigator's and subject's ratings of the severity of glabellar rhytides at maximum frown on a 4-point categorical scale, at which time he/she will receive another treatment of Mentor Purified Toxin.
If a subject chooses not to be re-treated with Mentor Purified Toxin when he/she becomes eligible for re-treatment, the subject will be followed up with the monthly telephone safety assessments and annual safety visits to the clinic. It is anticipated that most subjects will receive multiple repeat treatments during this study.
- Conditions
- Glabellar Rhytides
- Being tested
- Mentor Purified Toxin Botulinum Toxin Type A
- Keywords
- Botulinum Toxin Type A, Botulinum Toxin, Glabellar Rhytides, Rhytides, Frown Lines, Neuromuscular Agents, Neurotoxin, Forehead, Eyebrow, Wrinkle, Frown Lines Between the Eyebrows
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
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 Mentor Purified Toxin. Subjects will have many Treatment Visits throughout the course of the three-year study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Mentor Purified Toxin Botulinum Toxin Type A Receives: Drug: Mentor Purified Toxin Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the incidences of treatment-emergent adverse events, serious treatment-emergent adverse events, and treatment-emergent laboratory abnormalities, when PurTox is administered in repeated treatments.
Measured: Throughout
Secondary outcomes (4)
Estimate across treatment cycles the frequency with which subjects are responders at Day 30, based on an assessment of rhytide severity at maximum frown of 0 or 1 by the investigator
Measured: Day 30/Across all Treatment Cycles
Estimate across treatment cycles the frequency with which subjects are responders at Day 30, based on an assessment of rhytide severity at maximum frown of 0 or 1 by the subject
Measured: Day 30/Across treatment all cycles
Estimate across treatment cycles the frequency with which subjects are responders at Day 30, based on assessments of rhytide severity at maximum frown of 0 or 1 by both the investigator and the subject
Measured: Day 30/Across all treatment cycles
Estimate across treatment cycles the frequency with which subjects, who are responders at Day 30, based on subject assessment at maximum frown, continue to be responders at Days 90, 120, 150, and 180.
Measured: Day 30 through Day 180/Across all treatment cycles
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 startFeb 2008
- Primary completionMay 2011
- Study completionMay 2011
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mentor Worldwide, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synteract, Inc.
- Responsible party
- Sponsor
- Investigators
- Corey Maas, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752258
- Sponsor's protocol ID
- PT-03c
- Acronym
- PT-03c
- Status last verified
- Sep 2011
- First submitted
- 11 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 III, Multi-Center, Long-Term, Repeat-Treatment, Open-Label, Single-Arm Trial to Demonstrate the Safety of Repeat Treatment With PurTox® for the Treatment of Glabellar Rhytides ("Frown Lines")
- ClinicalTrials.gov ID
- NCT00752258
- Acronym / sponsor ID
- PT-03c / PT-03c
- 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
- 576 participants (actual)
- Lead sponsor
- Mentor Worldwide, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Synteract, Inc.
- Study start
- Feb 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (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 long-term safety of repeat treatment with an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines.
Detailed description
This is a Phase III, multi-center, open-label study to evaluate the long-term safety of repeat treatment with PurTox for the treatment of glabellar rhytides. Up to 576 patients will be enrolled at 12 sites in the U.S.A. and some of these patients may have participated in Mentor Purified Toxin Phase I, II and IIIa studies. Safety and tolerability of the repeat treatment with Mentor Purified Toxin will be examined during the study.
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)
All subjects meeting the study eligibility criteria will be treated with 30 U of Mentor Purified Toxin. Following the treatment, follow-up assessments are scheduled as follows: telephone safety assessments on post-treatment Days 7 and 14, a clinic visit on post-treatment Day 30, and a telephone safety assessment on post-treatment Day 60 and monthly thereafter until re-treatment.
A subject will be re-treated when he/she attains grade 2 (Moderate) or 3 (Severe) in the investigator's and subject's ratings of the severity of glabellar rhytides at maximum frown on a 4-point categorical scale, but not earlier than 90 days following the prior treatment. The subject will call the site when he/she rates the glabellar rhytides as grade 2 or 3 in severity to schedule an appointment for re-evaluation and possible re-treatment. The appointment must occur within 2 weeks of the subject's call but not earlier than 90 days post the previous injection. If at the clinic visit the subject's glabellar rhytides are graded by the investigator as grade 2 or 3 in severity and other eligibility criteria are met (e.g., negative urine pregnancy test in female subjects of childbearing potential), the subject will be re-treated. If a subject is eligible for re-treatment on or before 90 days post the previous injection, he/she will receive treatment of Mentor Purified Toxin on or after 90 days. If a subject is not eligible for re-treatment at 90 days, he/she can return to the clinic monthly until attaining grade 2 (Moderate) or 3 (Severe) in the investigator's and subject's ratings of the severity of glabellar rhytides at maximum frown on a 4-point categorical scale, at which time he/she will receive another treatment of Mentor Purified Toxin.
If a subject chooses not to be re-treated with Mentor Purified Toxin when he/she becomes eligible for re-treatment, the subject will be followed up with the monthly telephone safety assessments and annual safety visits to the clinic. It is anticipated that most subjects will receive multiple repeat treatments during this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Mentor Purified Toxin Botulinum Toxin Type AMentor Purified Toxin Botulinum Toxin Type A |
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 with 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 (18 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 criterion; 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, endocrine, 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 ToxinAll 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 Mentor Purified Toxin. Subjects will have many Treatment Visits throughout the course of the three-year study. | Drug | 1 |
Primary outcome
Estimation of the incidences of treatment-emergent adverse events, serious treatment-emergent adverse events, and treatment-emergent laboratory abnormalities, when PurTox is administered in repeated treatments.
Time frame: Throughout
4 secondary outcomes
Estimate across treatment cycles the frequency with which subjects are responders at Day 30, based on an assessment of rhytide severity at maximum frown of 0 or 1 by the investigator
Time frame: Day 30/Across all Treatment Cycles
Estimate across treatment cycles the frequency with which subjects are responders at Day 30, based on an assessment of rhytide severity at maximum frown of 0 or 1 by the subject
Time frame: Day 30/Across treatment all cycles
Estimate across treatment cycles the frequency with which subjects are responders at Day 30, based on assessments of rhytide severity at maximum frown of 0 or 1 by both the investigator and the subject
Time frame: Day 30/Across all treatment cycles
Estimate across treatment cycles the frequency with which subjects, who are responders at Day 30, based on subject assessment at maximum frown, continue to be responders at Days 90, 120, 150, and 180.
Time frame: Day 30 through Day 180/Across all treatment cycles
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.
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 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 Mentor Purified Toxin Botulinum Toxin Type A 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 18 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. 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?
Estimation of the incidences of treatment-emergent adverse events, serious treatment-emergent adverse events, and treatment-emergent laboratory abnormalities, when PurTox is administered in repeated treatments. (time frame: Throughout). 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; AzTrials last refreshed its copy on 7 Nov 2026.