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Completed

NCT Number: NCT00884234

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

The purpose of this study is to determine the safety and efficacy of 2 sequential doses of RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2.

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Key information

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Suzanne Bruce & Associates / The Center for Skin Research

Houston, Texas, 77056, United States

About this study

This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the safety and efficacy of repeat application of RT001 in at least 30 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (RT001 Dose A or vehicle control).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female/male ages 30 to 55
  • Bilateral lateral canthal lines rated as moderate or advanced.
  • Willing to refrain from any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at screening through Week 6.
  • Women of child baring potential must practice and be willing to continue to use an effective method of birth control.

Exclusion criteria

  • Muscle weakness or paralysis in the area receiving treatment.
  • Active skin disease or irritation at 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 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).
  • Any abnormality on the electrocardiogram (ECG) at screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive hear failure.

Treatment and study plan

Vehicle Control

Other

Two sequential doses of Vehicle Control at Baseline (Day 0) and Week 2

RT001 (Botulinum Toxin Type A Topical Gel)

Drug

Two sequential doses of RT001 at Baseline (Day 0) and Week 2

Primary outcomes

  1. The number of subjects classified as exhibiting improvement via the Investigator Global Assessment from Baseline (Day 0) to End of Study (Week 6).

    Time frame: Baseline (Day 0) and Week 6

  2. Incidence of treatment emergent AEs.

    Time frame: Baseline (Day 0) and Week 6

Sponsors and collaborators

Lead sponsor

Revance Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Repeat Dose, Single Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment of Moderate to Severe Lateral Canthal Lines In Adults

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 20, 2009
Registry last updated
Aug 28, 2020

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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