Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

Revance Therapeutics

Status and phase: Completed; Phase 2

Conditions: Lateral Canthal Lines; Facial Wrinkles; Crow's Feet

Treatments: Drug: Placebo (Dose B); Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01064518

RT001-CL024LCL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

Dose A

Active Comparator group

Description:

RT001 Topical Gel

Treatment:

Drug: Botulinum Toxin Type A

Dose B

Placebo Comparator group

Description:

Placebo Comparator

Treatment:

Drug: Placebo (Dose B)