Lateral Canthal LinesPhase 2NCT00884234
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
A Phase 2 study testing RT001 (Botulinum Toxin Type A Topical Gel) in people with Lateral Canthal Lines, run by Revance Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of 2 sequential doses of RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Canthal Lines
- What is being tested?
- RT001 (Botulinum Toxin Type A Topical Gel)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female/male ages 30 to 55
- Bilateral lateral canthal lines rated as moderate or advanced.
- Willing to refrain from any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at screening through Week 6.
- Women of child baring potential must practice and be willing to continue to use an effective method of birth control.
Who cannot join
- Muscle weakness or paralysis in the area receiving treatment.
- Active skin disease or irritation at treatment areas.
- Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to screening.
- Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0).
- Use of 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 (Week 6).
- Any abnormality on the electrocardiogram (ECG) at screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive hear failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Suzanne Bruce & Associates / The Center for Skin Research
Houston, Texas, 77056
About this study
Official title: A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Repeat Dose, Single Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment of Moderate to Severe Lateral Canthal Lines In Adults
The purpose of this study is to determine the safety and efficacy of 2 sequential doses of RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2.
Read the detailed description
This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the safety and efficacy of repeat application of RT001 in at least 30 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (RT001 Dose A or vehicle control).
- Conditions
- Lateral Canthal Lines
- Being tested
- Vehicle Control, RT001 (Botulinum Toxin Type A Topical Gel)
- Keywords
- Lateral Canthal Lines, Crow's Feet, Facial Wrinkles, Lateral Canthal Area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vehicle ControlOther
Two sequential doses of Vehicle Control at Baseline (Day 0) and Week 2
RT001 (Botulinum Toxin Type A Topical Gel)Drug
Two sequential doses of RT001 at Baseline (Day 0) and Week 2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | RT001 (Botulinum Toxin Type A Topical Gel) Receives: Drug: RT001 (Botulinum Toxin Type A Topical Gel) |
| 2 | Placebo comparator | Vehicle Control Receives: Other: Vehicle Control |
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 from Baseline (Day 0) to End of Study (Week 6).
Measured: Baseline (Day 0) and Week 6
Incidence of treatment emergent AEs.
Measured: Baseline (Day 0) and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2009
- Study completionJun 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revance Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzanne Bruce, MD, Principal investigator, The Center for Skin Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884234
- Sponsor's protocol ID
- RT001-CL011LCL
- Status last verified
- Aug 2020
- First submitted
- 17 Apr 2009
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Repeat Dose, Single Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment of Moderate to Severe Lateral Canthal Lines In Adults
- ClinicalTrials.gov ID
- NCT00884234
- Acronym / sponsor ID
- RT001-CL011LCL
- Conditions
- Lateral Canthal Lines
- Keywords
- Lateral Canthal Lines, Crow's Feet, Facial Wrinkles, Lateral Canthal Area
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 20 Apr 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 determine the safety and efficacy of 2 sequential doses of RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2.
Detailed description
This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the safety and efficacy of repeat application of RT001 in at least 30 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (RT001 Dose A or vehicle control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RT001 (Botulinum Toxin Type A Topical Gel)RT001 (Botulinum Toxin Type A Topical Gel) |
| 2 | Placebo comparator | Other: Vehicle ControlVehicle Control |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female/male ages 30 to 55
- Bilateral lateral canthal lines rated as moderate or advanced.
- Willing to refrain from any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at screening through Week 6.
- Women of child baring potential must practice and be willing to continue to use an effective method of birth control.
Key exclusion criteria (6 listed)
- Muscle weakness or paralysis in the area receiving treatment.
- Active skin disease or irritation at treatment areas.
- Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to screening.
- Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0).
- Use of 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 (Week 6).
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 |
|---|---|---|
| Vehicle ControlTwo sequential doses of Vehicle Control at Baseline (Day 0) and Week 2 | Other | 2 |
| RT001 (Botulinum Toxin Type A Topical Gel)Two sequential doses of RT001 at Baseline (Day 0) and Week 2 | Drug | 1 |
Primary outcome
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment from Baseline (Day 0) to End of Study (Week 6).
Time frame: Baseline (Day 0) and Week 6
Incidence of treatment emergent AEs.
Time frame: Baseline (Day 0) and Week 6
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 28 Aug 2020.
Related trials for Lateral Canthal Lines
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Not yet recruitingPhase 4
A Real-World Study on Effect of Hirudoid on Ecchymosis After Treatment of Crow's Feet With Botulinum Toxin Type A
Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type A, Crow's Feet Lines
Active, not recruitingPhase 1
A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions
Skin Roughness, Wrinkle
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.
Suzanne Bruce, MD principal investigator
The Center for Skin Research
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 Topical Gel) in people with Lateral Canthal Lines, 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 6 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 28 Aug 2020. 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?
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment from Baseline (Day 0) to End of Study (Week 6). (time frame: Baseline (Day 0) and Week 6). 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 28 Aug 2020.