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RT001

Phase 2

Lateral Canthal Lines | Small molecule | Dermatology |Revance Therapeutics, Inc.|Last Updated: Aug 28, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials4
Total Enrollment202

FDA Designations

No designations recorded

Clinical trial landscape

RT001 · 4 trials · 3 indications

Phase 2 4
NCT01124565Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in AdultsLateral Canthal Lines
COMPLETED40 Analytics
NCT00907387Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal LinesLateral Canthal Lines
COMPLETED72 Analytics
NCT00884234Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal LinesLateral Canthal Lines
COMPLETED30 Analytics
NCT00888914Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal LinesLateral Canthal Lines
COMPLETED60 Analytics
PHASE2COMPLETED
Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
Lateral Canthal Lines
NCT0112456540
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PHASE2COMPLETED
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
Lateral Canthal Lines
NCT0090738772
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PHASE2COMPLETED
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
Lateral Canthal Lines
NCT0088423430
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PHASE2COMPLETED
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
Lateral Canthal Lines
NCT0088891460
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Study Endpoints

Primary Endpoints

Assessment of treatment-emergent adverse events based on safety assessments.
4 weeks and 8 weeks
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to Day 28
Day 28
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment from Baseline (Day 0) to End of Study (Week 6).
Baseline (Day 0) and Week 6
Incidence of treatment emergent AEs.
Baseline (Day 0) and Week 6
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Smile from Baseline (Day 0) to End of Study (Day 28)
Day 28

Secondary Endpoints

Incidence of treatment-emergent adverse events
Day 28
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to End of Study (Day 28)
Day 28
Incidence of treatment-emergent AEs
Day 28
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RT001EXPERIMENTALRT001 (Botulinum Toxin Type A) Topical Gel
Dose AACTIVE_COMPARATORDose A RT001
Dose BACTIVE_COMPARATORDose B RT001
Dose CPLACEBO_COMPARATORDose C Placebo
1EXPERIMENTALRT001 (Botulinum Toxin Type A Topical Gel)
2PLACEBO_COMPARATORVehicle Control
Dose DACTIVE_COMPARATORRT001 Dose D; Active Comparator
Dose EPLACEBO_COMPARATORRT001 Dose E; Vehicle Comparator

Interventions

NameTypeDescription
RT001DRUGRT001 (Botulinum Toxin Type A Topical Gel, Dose A) at Baseline (Day 0) and Week 4 to the lateral canthal areas
PlaceboOTHERDose C Placebo
Vehicle ControlOTHERTwo sequential doses of Vehicle Control at Baseline (Day 0) and Week 2
RT001 (Botulinum Toxin Type A Topical Gel)DRUGTwo sequential doses of RT001 at Baseline (Day 0) and Week 2
Vehicle ComparatorOTHERVehicle Comparator
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * 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 ...

Countries:United States
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Frequently asked questions about RT001

What is RT001 used for?

RT001 is an investigational small molecule being developed for the treatment of moderate to severe lateral canthal lines, commonly known as crow's feet. It is being studied in the dermatology therapeutic area for facial wrinkles. The drug is administered to adults, with clinical trials enrolling participants aged 18 years and older.

Who makes RT001?

RT001 is being developed by Revance Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RVNC. The company is conducting clinical research on this investigational drug for the treatment of lateral canthal lines, which are facial wrinkles around the eyes.

What phase is RT001 in?

RT001 is in Phase 2 clinical development. It has completed four Phase 2 trials, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities. All completed studies were randomized, double-blind, and placebo-controlled, involving a total of 202 participants.

What clinical trials is RT001 in?

RT001 has completed four Phase 2 clinical trials in the United States. These include NCT00884234 with 30 participants, NCT00888914 with 60 participants, NCT00907387 with 72 participants, and NCT01124565 with 40 participants. All trials studied the drug's safety and efficacy for treating moderate to severe lateral canthal lines.

Is RT001 the same as a botulinum toxin treatment?

RT001 is a small molecule, not a botulinum toxin. It is being developed by Revance Therapeutics for lateral canthal lines, or crow's feet. The drug is distinct from botulinum toxin products and is being studied as an alternative treatment for facial wrinkles in clinical trials.