Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01124565
First received: May 12, 2010
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

This study's objective is to evaluate if RT001 is safe and well-tolerated following two (2) sequential applications.


Condition Intervention Phase
Lateral Canthal Lines
Crow's Feet
Facial Wrinkles
Drug: RT001
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Repeat Dose, Multi-Center Study to Evaluate the Safety of RT001 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:
  • Assessment of treatment-emergent adverse events based on safety assessments. [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: May 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RT001
RT001 (Botulinum Toxin Type A) Topical Gel
Drug: RT001
RT001 (Botulinum Toxin Type A Topical Gel, Dose A) at Baseline (Day 0) and Week 4 to the lateral canthal areas

Detailed Description:

Revance is conducting this Phase 2 clinical study to establish the safety of two (2) sequential doses of RT001 Topical Gel at Baseline (Day 0) and Week 4 for the treatment of moderate to severe LCLs at rest.

  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 child bearing potential (WOCBP) but is not willing to use an effective method of birth control
  • Previous participation in a RT001 clinical study
  • Previous treatment with botulinum toxin (any serotype)
  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: NCT01124565

Locations
United States, Alabama
Total Skin & Beauty Dermatology Center, PC
Birmingham, Alabama, United States, 35205
United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
Sponsors and Collaborators
Revance Therapeutics, Inc.
Investigators
Principal Investigator: Joel Schlessinger, M.D. Skin Specialists, PC
  More Information

No publications provided

Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01124565     History of Changes
Other Study ID Numbers: RT001-CL025LCL
Study First Received: May 12, 2010
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014