A 4-Arm 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: RT001 Botulinum toxin type A (Dose A); Other: Vehicle; Drug: RT001 Botulinum Toxin Type A (Dose B); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01124552

RT001-CL017LCL

Details and patient eligibility

About

The purpose of this study is to find out if an investigational drug, called RT001 Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called lateral canthal lines, also known as crow's feet wrinkles.

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 RT001 is more effective than three comparator groups by examining the effect on the improvement of crow's feet by both the patient and physician.

Enrollment: 180 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 women of child bearing 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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180 participants in 4 patient groups, including a placebo group

RT001 Botulinum toxin Type A (Dose A)

Experimental group

Description:

RT001 (Botulinum toxin Type A)

Treatment:

Drug: RT001 Botulinum toxin type A (Dose A)

RT001 Botulinum toxin type A (Dose B)

Experimental group

Description:

RT001 (Botulinum Toxin Type A)

Treatment:

Drug: RT001 Botulinum Toxin Type A (Dose B)

Dose C

Other group

Description:

Vehicle Control

Treatment:

Other: Vehicle

Dose D

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo