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Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines

Sponsored by Revance Therapeutics, Inc.

About this trial

Last updated 11 years ago

Study ID

RT001-CL010LCL

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18-75 Years
30 to 60 Years
All
All

Trial Timing

Ended 16 years ago

What is this trial about?

The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults and duration of effect.

What are the participation requirements?

Yes

Inclusion Criteria

- Female or male, 30 to 60 years of age

- Bilateral lateral canthal lines rated as moderate or severe

- Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening and through End of Study

- Women of childbearing potential must be practicing and willing to continue to use an effective method of birth control during the course of the study

No

Exclusion Criteria

- Muscle weakness or paralysis in the area receiving study treatment -Active skin disease or irritation at the treatment areas

- Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to Screening

- Use of a 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 (Day 28)

- Any abnormality on the electrocardiogram (ECG) at Screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive heart failure.

- Previous treatment with Botulinum Toxin Type A in the face area