Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

A Phase 2, Open-Label, Repeat Dose, Multi-Center Study to Evaluate the Safety of RT001 Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01124565

Enrollment

Registered

2010-05-17

Start date

2010-05-31

Completion date

2010-07-31

Last updated

2014-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crow's Feet, Facial Wrinkles, Lateral Canthal Lines

Keywords

Lateral Canthal Lines, Crow's Feet, Facial Wrinkles

Brief summary

This study's objective is to evaluate if RT001 is safe and well-tolerated following two (2) sequential applications.

Detailed description

Revance is conducting this Phase 2 clinical study to establish the safety of two (2) sequential doses of RT001 Topical Gel at Baseline (Day 0) and Week 4 for the treatment of moderate to severe LCLs at rest.

Interventions

DRUGRT001

RT001 (Botulinum Toxin Type A Topical Gel, Dose A) at Baseline (Day 0) and Week 4 to the lateral canthal areas

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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 lines (crow's feet wrinkles)

Exclusion criteria

* 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 woman of child bearing potential (WOCBP) but is not willing to use an effective method of birth control * Previous participation in a RT001 clinical study * Previous treatment with botulinum toxin (any serotype)

Design outcomes

Primary

Measure	Time frame
Assessment of treatment-emergent adverse events based on safety assessments.	4 weeks and 8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026