Lateral Canthal LinesPhase 2NCT00907387
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
A Phase 2 study testing RT001 in people with Lateral Canthal Lines, run by Revance Therapeutics, Inc. at 9 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults and duration of effect. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Canthal Lines
- What is being tested?
- RT001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 9 sitesUnited States
- Study dates
- Apr 2009to Oct 2009
- Phase
- Phase 2
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female or male, 30 to 60 years of age
- Bilateral lateral canthal lines rated as moderate or severe
- Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening and through End of Study
- Women of childbearing potential must be practicing and willing to continue to use an effective method of birth control during the course of the study
Who cannot join
- Muscle weakness or paralysis in the area receiving study treatment -Active skin disease or irritation at the treatment areas
- Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to Screening
- Use of a topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to Screening and continuing through End of Study (Day 28)
- Any abnormality on the electrocardiogram (ECG) at Screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive heart failure.
- Previous treatment with Botulinum Toxin Type A in the face area
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, 35205
SkinCare Physicians, Inc.
Chestnut Hill, Massachusetts, 02467
Dermatology Research Institute, LLC
Coral Gables, Florida, 33146
Suzanne Bruce & Associates / The Center for Skin Research
Houston, Texas, 77056
Head and Neck Surgical Group
New York, New York, 10019
Aesthetic Plastic Surgery
New York, New York, 10065
Skin Specialists, PC
Omaha, Nebraska, 68144
Richard G. Glogau, Inc.
San Francisco, California, 94117
Dermatology Surgery and Laser Center
White Plains, New York, 10604
About this study
Official title: A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment Lateral Canthal Lines in Adults
The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults and duration of effect.
Read the detailed description
This is a double-blind, randomized, parallel-group, controlled, dose-ranging, multi-center study to evaluate the safety and efficacy of RT001 compared to placebo applied as a single, bilateral application in at least 180 subjects with moderate to severe LCLs. Subjects will be randomized within each site to 1 of 3 treatment groups in a 1:1:1 ratio. The safety and efficacy of two different doses of RT001, compared to placebo, will be evaluated.
At least 180 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. Subjects will be enrolled in two (2) sequential cohorts. Cohort 1 will consist of 72 subjects; 24 subjects per treatment group. Cohort 2 will consist of 108 subjects; 36 subjects per treatment group. In order to confirm the safety of the test articles, Cohort 2 will not be enrolled until all Cohort 1 subjects have reached Day 14 or later with no Study Pause Criteria being observed.
- Conditions
- Lateral Canthal Lines
- Being tested
- RT001, Placebo
- Keywords
- Lateral Canthal Lines, Crow's Feet, Facial Wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT001Drug
Dose A RT001
RT001Drug
Dose B RT001
PlaceboOther
Dose C Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose A | Active comparator | Dose A RT001 Receives: Drug: RT001 |
| Dose B | Active comparator | Dose B RT001 Receives: Drug: RT001 |
| Dose C | Placebo comparator | Dose C Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to Day 28
Measured: Day 28
Secondary outcomes (1)
Incidence of treatment-emergent adverse events
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Canthal LinesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revance Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Debbie Tranowski, Study director, Revance Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907387
- Sponsor's protocol ID
- RT001-CL010LCL
- Status last verified
- Dec 2013
- First submitted
- 20 May 2009
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment Lateral Canthal Lines in Adults
- ClinicalTrials.gov ID
- NCT00907387
- Acronym / sponsor ID
- RT001-CL010LCL
- Conditions
- Lateral Canthal Lines
- Keywords
- Lateral Canthal Lines, Crow's Feet, Facial Wrinkles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 May 2009 (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 purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults and duration of effect.
Detailed description
This is a double-blind, randomized, parallel-group, controlled, dose-ranging, multi-center study to evaluate the safety and efficacy of RT001 compared to placebo applied as a single, bilateral application in at least 180 subjects with moderate to severe LCLs. Subjects will be randomized within each site to 1 of 3 treatment groups in a 1:1:1 ratio. The safety and efficacy of two different doses of RT001, compared to placebo, will be evaluated.
At least 180 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. Subjects will be enrolled in two (2) sequential cohorts. Cohort 1 will consist of 72 subjects; 24 subjects per treatment group. Cohort 2 will consist of 108 subjects; 36 subjects per treatment group. In order to confirm the safety of the test articles, Cohort 2 will not be enrolled until all Cohort 1 subjects have reached Day 14 or later with no Study Pause Criteria being observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose A | Active comparator | Drug: RT001Dose A RT001 |
| Dose B | Active comparator | Drug: RT001Dose B RT001 |
| Dose C | Placebo comparator | Other: PlaceboDose C Placebo |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female or male, 30 to 60 years of age
- Bilateral lateral canthal lines rated as moderate or severe
- Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening and through End of Study
- Women of childbearing potential must be practicing and willing to continue to use an effective method of birth control during the course of the study
Key exclusion criteria (5 listed)
- Muscle weakness or paralysis in the area receiving study treatment -Active skin disease or irritation at the treatment areas
- Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to Screening
- Use of a topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to Screening and continuing through End of Study (Day 28)
- Any abnormality on the electrocardiogram (ECG) at Screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive heart failure.
- Previous treatment with Botulinum Toxin Type A in the face 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 |
|---|---|---|
| RT001Dose A RT001 | Drug | Dose A |
| RT001Dose B RT001 | Drug | Dose B |
| PlaceboDose C Placebo | Other | Dose C |
Primary outcome
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to Day 28
Time frame: Day 28
1 secondary outcome
Incidence of treatment-emergent adverse events
Time frame: Day 28
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 17 Jan 2014.
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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.
Debbie Tranowski study director
Revance Therapeutics, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RT001 in people with Lateral Canthal Lines, run by Revance Therapeutics, Inc. at 9 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 4 inclusion and 5 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 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to Day 28 (time frame: Day 28). 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 17 Jan 2014.