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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Revance Therapeutics, Inc.

Criteria

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

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