Lateral Canthal LinesPhase 2NCT01124552
A 4-Arm Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
A Phase 2 study testing RT001 Botulinum toxin type A (Dose A) and RT001 Botulinum Toxin Type A (Dose B) in people with Lateral Canthal Lines and Crow's Feet, run by Revance Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to find out if an investigational drug, called RT001 Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called lateral canthal lines, also known as crow's feet wrinkles. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Canthal Lines, Crow's Feet, Facial Wrinkles
- What is being tested?
- RT001 Botulinum toxin type A (Dose A) and RT001 Botulinum Toxin Type A (Dose B)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jul 2010
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent including authorization to release health information
- Female or male, 18 to 65 years of age and in good general health
- Willing and able to follow study instructions and likely to complete all study requirements
- Moderate to severe lateral canthal lines (crow's feet wrinkles)
Who cannot join
- Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
- Muscle weakness or paralysis, particularly in the area receiving study treatment
- Active disease or irritation at the treatment areas including the eye and the skin
- Pregnant, nursing, or planning a pregnancy during the study; or is a women of child bearing potential (WOCBP) but is not willing to use an effective method of birth control
- Previous participation in a RT001 clinical study
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Research Institute, LLC
Coral Gables, Florida, 33146
About this study
Official title: A Phase 2, Double-Blind, Randomized, 4-Arm, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of RT001 Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
The purpose of this study is to find out if an investigational drug, called RT001 Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called lateral canthal lines, also known as crow's feet wrinkles.
Read the detailed description
RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001 is more effective than three comparator groups by examining the effect on the improvement of crow's feet by both the patient and physician.
- Conditions
- Lateral Canthal Lines, Crow's Feet, Facial Wrinkles
- Being tested
- RT001 Botulinum toxin type A (Dose A), RT001 Botulinum Toxin Type A (Dose B), Vehicle, Placebo
- Keywords
- Lateral Canthal Lines, Crow's Feet Wrinkles, Facial Wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT001 Botulinum toxin type A (Dose A)Drug
RT001 Botulinum Toxin Type A (Dose A)
RT001 Botulinum Toxin Type A (Dose B)Drug
RT001 Botulinum Toxin Type A (Dose B)
VehicleOther
Vehicle Control
PlaceboDrug
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| RT001 Botulinum toxin Type A (Dose A) | Experimental | RT001 (Botulinum toxin Type A) Receives: Drug: RT001 Botulinum toxin type A (Dose A) |
| RT001 Botulinum toxin type A (Dose B) | Experimental | RT001 (Botulinum Toxin Type A) Receives: Drug: RT001 Botulinum Toxin Type A (Dose B) |
| Dose C | Other | Vehicle Control Receives: Other: Vehicle |
| Dose D | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject improvement based in investigator assessment
The number of subjects who show improvement based on the investigator global assessment
Measured: Week 4
Secondary outcomes (1)
Subject Improvement Based on investigator and patient assessments
The number of subjects who show improvement based on the investigator global and patient assessments
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionJul 2010
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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revance Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124552
- Sponsor's protocol ID
- RT001-CL017LCL
- Status last verified
- Dec 2013
- First submitted
- 6 May 2010
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized, 4-Arm, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of RT001 Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
- ClinicalTrials.gov ID
- NCT01124552
- Acronym / sponsor ID
- RT001-CL017LCL
- Conditions
- Lateral Canthal Lines, Crow's Feet, Facial Wrinkles
- Keywords
- Lateral Canthal Lines, Crow's Feet Wrinkles, Facial Wrinkles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 17 May 2010 (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 find out if an investigational drug, called RT001 Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called lateral canthal lines, also known as crow's feet wrinkles.
Detailed description
RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001 is more effective than three comparator groups by examining the effect on the improvement of crow's feet by both the patient and physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RT001 Botulinum toxin Type A (Dose A) | Experimental | Drug: RT001 Botulinum toxin type A (Dose A)RT001 (Botulinum toxin Type A) |
| RT001 Botulinum toxin type A (Dose B) | Experimental | Drug: RT001 Botulinum Toxin Type A (Dose B)RT001 (Botulinum Toxin Type A) |
| Dose C | Other | Other: VehicleVehicle Control |
| Dose D | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent including authorization to release health information
- Female or male, 18 to 65 years of age and in good general health
- Willing and able to follow study instructions and likely to complete all study requirements
- Moderate to severe lateral canthal lines (crow's feet wrinkles)
Key exclusion criteria (5 listed)
- Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
- Muscle weakness or paralysis, particularly in the area receiving study treatment
- Active disease or irritation at the treatment areas including the eye and the skin
- Pregnant, nursing, or planning a pregnancy during the study; or is a women of child bearing potential (WOCBP) but is not willing to use an effective method of birth control
- Previous participation in a RT001 clinical study
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 |
|---|---|---|
| RT001 Botulinum toxin type A (Dose A)RT001 Botulinum Toxin Type A (Dose A) | Drug | RT001 Botulinum toxin Type A (Dose A) |
| RT001 Botulinum Toxin Type A (Dose B)RT001 Botulinum Toxin Type A (Dose B) | Drug | RT001 Botulinum toxin type A (Dose B) |
| VehicleVehicle Control | Other | Dose C |
| PlaceboPlacebo Comparator | Drug | Dose D |
Primary outcome
Subject improvement based in investigator assessment
Time frame: Week 4
The number of subjects who show improvement based on the investigator global assessment
1 secondary outcome
Subject Improvement Based on investigator and patient assessments
Time frame: Week 4
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 30 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Botulinum toxin type A (Dose A) and RT001 Botulinum Toxin Type A (Dose B) in people with Lateral Canthal Lines and Crow's Feet, run by Revance Therapeutics, Inc. 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 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 30 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 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 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?
Subject improvement based in investigator assessment (time frame: Week 4). 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 30 Jan 2014.