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RT001

Phase 2

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

RT001 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Apr 2009

RT001 target and mechanism

ModalitySmall molecule

Also known as RT001 (Botulinum Toxin Type A Topical Gel)

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

RT001 clinical trials

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 LinesUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
Lateral Canthal LinesUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
Lateral Canthal LinesUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
Lateral Canthal LinesUnlock trial analytics

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 being developed for the treatment of moderate to severe lateral canthal lines, commonly known as crow's feet or facial wrinkles around the eyes. It is a topical gel formulation of botulinum toxin type A applied to the skin, and it is in Phase 2 clinical development for this dermatologic indication.

Who makes RT001?

RT001 is developed by Revance Therapeutics, Inc., which trades under the ticker RVNC. The company is the sponsor of the clinical program evaluating RT001 for lateral canthal lines.

What phase is RT001 in?

RT001 is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA. Four Phase 2 trials of RT001 have been completed, and no trials are currently active.

What clinical trials is RT001 in?

RT001 has been studied in four completed Phase 2 trials: NCT01124565, NCT00907387, NCT00888914, and NCT00884234. These trials evaluated RT001 for moderate to severe lateral canthal lines in the United States, with total enrollment of 202 participants across the program.

How was RT001 studied in clinical trials?

The RT001 Phase 2 trials were randomized, double-blind, and placebo-controlled. They enrolled adults with moderate to severe lateral canthal lines, with minimum ages of 18 or 30 years depending on the study, and included both healthy volunteers and non-healthy volunteers across the four completed trials.

Is RT001 the same as botulinum toxin type A topical gel?

Yes. RT001 is also known as RT001 (Botulinum Toxin Type A Topical Gel). It is a topical gel formulation of botulinum toxin type A developed by Revance Therapeutics for lateral canthal lines, and searches for either name refer to the same investigational asset.