Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
This study has been completed.
Sponsor:
Revance Therapeutics, Inc.
Information provided by:
Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01064518
First received: February 4, 2010
Last updated: June 24, 2011
Last verified: June 2011
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Purpose
The purpose of this study is to find out if an investigational drug, called RT001 Botulinum Toxin Type A Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called crow's feet, also known as lateral canthal lines.
| Condition | Intervention | Phase |
|---|---|---|
|
Lateral Canthal Lines Crow's Feet Facial Wrinkles |
Drug: Botulinum Toxin Type A |
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 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 who show improvement based on the investigator global and patient assessments. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The number of subjects who show improvement based on the investigator global and patient assessments. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
| Enrollment: | 90 |
| Study Start Date: | January 2010 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Dose A
RT001 Topical Gel
|
Drug: Botulinum Toxin Type A
RT001 (Botulinum Toxin Type A Topical Gel, Dose A) or Placebo (Dose B), applied topically at Baseline (Day 0) to the lateral canthal lines
|
|
Placebo Comparator: Dose B
Placebo Comparator
|
Drug: Botulinum Toxin Type A
RT001 (Botulinum Toxin Type A Topical Gel, Dose A) or Placebo (Dose B), applied topically at Baseline (Day 0) to the lateral canthal lines
|
Detailed Description:
RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001is more effective than placebo gel by examining the effect on the improvement of crow's feet by both the patient and physician.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Written informed consent including authorization to release health information
- Female or male, 18 to 65 years of age and in good general health
- Willing and able to follow study instructions and likely to complete all study requirements
- Moderate to severe lateral canthal lines (crow's feet wrinkles)
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 neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
- Muscle weakness or paralysis, particularly in the area receiving study treatment
- Active disease or irritation at the treatment areas including the eye and the skin
- Pregnant, nursing, or planning a pregnancy during the study; or is a woman of childbearing potential (WOCBP) but is not willing to use an effective method of birth control
- Previous participation in a RT001 clinical study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064518
Locations
| United States, Florida | |
| Dermatology Research Institute, LLC | |
| Coral Gables, Florida, United States, 33146 | |
Sponsors and Collaborators
Revance Therapeutics, Inc.
Investigators
| Principal Investigator: | Fredric Brandt, MD | Dermatology Research Institute, LLC |
More Information
No publications provided
| Responsible Party: | Deborah Tranowski, Vice President, Clinical Operations, Revance Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01064518 History of Changes |
| Other Study ID Numbers: | RT001-CL024LCL |
| Study First Received: | February 4, 2010 |
| Last Updated: | June 24, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Revance Therapeutics, Inc.:
|
Lateral Canthal Lines Crow's Feet Wrinkles 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 May 22, 2013