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

NCT00888914 | Completed Phase 2

• 1 other identifier: RT001-CL006LCL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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.

Conditions

Lateral Canthal Lines; Crow's Feet; Facial Wrinkles

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 Smile from Baseline (Day 0) to End of Study (Day 28)

  Day 28

Secondary Outcomes (2)

• 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

Study Arms (5)

Dose A

ACTIVE COMPARATOR

RT001 Dose A; Active Comparator

Drug: RT001

Dose B

ACTIVE COMPARATOR

RT001 Dose B; Active Comparator

Drug: RT001

Dose C

ACTIVE COMPARATOR

RT001 Dose C; Active Comparator

Drug: RT001

Dose D

ACTIVE COMPARATOR

RT001 Dose D; Active Comparator

Drug: RT001

Dose E

PLACEBO COMPARATOR

RT001 Dose E; Vehicle Comparator

Other: Vehicle Comparator

Interventions

RT001 DRUG

RT001

Dose B

Vehicle Comparator OTHER

Vehicle Comparator

Dose E

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female or male; 30 to 55 years of age
• Bilateral lateral canthal lines rated as moderate or advanced
• Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening 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
• Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0)
• 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

Sponsors & Collaborators

• Revance Therapeutics, Inc.: lead

Study Sites (4)

Richard G. Glogau, MD

San Francisco, California, 94117, 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

MeSH Terms

Interventions

RT001

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: April 24, 2009
• First Posted: April 28, 2009
• Study Start: November 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: February 1, 2009
• Last Updated: November 19, 2013

Record last verified: 2013-10

Locations

US (4)