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

NCT00907387 | Completed Phase 2

• 1 other identifier: RT001-CL010LCL
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Lateral Canthal Lines

Keywords

Lateral Canthal Lines; Crow's Feet; Facial Wrinkles

Outcome Measures

Primary Outcomes (1)

• The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to Day 28

  Day 28

Secondary Outcomes (1)

• Incidence of treatment-emergent adverse events

  Day 28

Study Arms (3)

Dose A

ACTIVE COMPARATOR

Dose A RT001

Drug: RT001

Dose B

ACTIVE COMPARATOR

Dose B RT001

Drug: RT001

Dose C

PLACEBO COMPARATOR

Dose C Placebo

Other: Placebo

Interventions

RT001 DRUG

Dose A RT001

Dose A

Placebo OTHER

Dose C Placebo

Dose C

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Revance Therapeutics, Inc.: lead

Study Sites (9)

Total Skin & Beauty Dermatology Center

Birmingham, Alabama, 35205, United States

Location

Richard G. Glogau, Inc.

San Francisco, California, 94117, United States

Location

Dermatology Research Institute, LLC

Coral Gables, Florida, 33146, United States

Location

SkinCare Physicians, Inc.

Chestnut Hill, Massachusetts, 02467, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Head and Neck Surgical Group

New York, New York, 10019, United States

Location

Aesthetic Plastic Surgery

New York, New York, 10065, United States

Location

Dermatology Surgery and Laser Center

White Plains, New York, 10604, United States

Location

Suzanne Bruce & Associates / The Center for Skin Research

Houston, Texas, 77056, United States

Location

MeSH Terms

Interventions

RT001

Study Officials

• Debbie Tranowski

  Revance Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 22, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 17, 2014

Record last verified: 2013-12

Locations

US (9)