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Completed

NCT Number: NCT01124565

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

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

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Key information

Conditions

Lateral Canthal Lines Crow's Feet Facial Wrinkles

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Total Skin & Beauty Dermatology Center, PC, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

RT001

Drug

RT001 (Botulinum Toxin Type A Topical Gel, Dose A) at Baseline (Day 0) and Week 4 to the lateral canthal areas

Primary outcomes

  1. Assessment of treatment-emergent adverse events based on safety assessments.

    Time frame: 4 weeks and 8 weeks

Sponsors and collaborators

Lead sponsor

Revance Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 17, 2010
Registry last updated
Jan 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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