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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00968825
First received: August 27, 2009
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to evaluate the efficacy and safety of a single administration of RT001 compared to placebo gel for the treatment of moderate to severe lateral canthal lines.


Condition Intervention Phase
Lateral Canthal Lines
Crow's Feet
Facial Wrinkles
Drug: Botulinum Toxin Type A
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Administration of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

Resource links provided by NLM:


Further study details as provided by Revance Therapeutics, Inc.:

Primary Outcome Measures:
  • The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line Severity at Rest from Baseline (Day 0) to Week 4; incidence of treatment emergent AEs [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line Severity at Rest and Smile from Baseline (Day 0) to Week 4 and Baseline (Day 0) to Week 6; incidence of treatment emergent AEs [ Time Frame: Week 4 and Week 6 ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: July 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dose D
RT001
Drug: Botulinum Toxin Type A
RT001 (Botulinum Toxin Type A Topical Gel) Dose D applied topically at Baseline (Day 0) to the lateral canthal lines
Placebo Comparator: Dose E
Placebo
Drug: Placebo
Placebo (Dose E) applied topically at Baseline (Day 0) to the lateral canthal lines

Detailed Description:

This is a double-blind, randomized, parallel-group, controlled, multi-center study to evaluate the efficacy and safety of a single administration of RT001 compared to placebo applied as a bilateral application in at least 72 subjects with moderate to severe Lateral Canthal Lines. Subjects will be randomized within each site to 1 of 2 treatment groups in a 1:1 ratio. The efficacy and safety of RT001 compared to placebo will be evaluated. Study follow-up visits will occur at Weeks 2, 4 and 6.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female or male, 30 to 60 years of age
  • Bilateral lateral canthal lines rated as moderate or severe based on the Investigator Global Assessment - Lateral Canthal Lines Rest and Investigator Global Assessment - Lateral Canthal Lines Smile Severity Scales
  • 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 (Week 6)
  • 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:

  • 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 euromuscular junctional disorders
  • Muscle weakness or paralysis in the area receiving study treatment
  • Active skin disease or irritation at the treatment areas
  • Eyelid ptosis, excessive dermatochalasis, deep dermal scarring or inability to substantially lessen the lateral canthal lines to be treated by physically spreading them apart
  • Use of prescription retinoid products during the past 3 months prior to Screening
  • Chemical peel (medium depth or deeper) during the past 9 months prior to Screening
  • Undergone any procedures that may affect the lateral canthal region such as: periorbital surgery, brow left or related procedures, laser skin resurfacing or soft tissue augmentation (upper half of face) during the past 12 months prior to Screening
  • Screening electrocardiogram (ECG) that is abnormal or clinically significant or any history of hypokalemia, torsade de pointe, unstable angina, myocardial infarction or congestive heart failure or family history of prolonged QT
  • Previous treatment with Botulinum Toxin Type A in the face area
  • Previous treatment with greater than 200 U Botulinum Toxin Type A anywhere else in the body within the last 6 months prior to Screening
  • Concurrent use of aminoglycoside antibiotics, or other agents that might interfere with neuromuscular transmission starting at 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 (Week 6)
  • Clinically significant laboratory values at Screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968825

Locations
United States, California
RGG, Inc
San Francisco, California, United States, 94117
Sponsors and Collaborators
Revance Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00968825     History of Changes
Other Study ID Numbers: RT001-CL012LCL
Study First Received: August 27, 2009
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Revance Therapeutics, Inc.:
Lateral Canthal Lines
Crow's Feet
Facial Wrinkles

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014