Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

Revance Therapeutics

Status and phase: Completed; Phase 2

Conditions: Skin Aging

Treatments: Drug: Placebo; Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01940991

RT001-CL035

Details and patient eligibility

About

This study will confirm the efficacy and safety of a single topical administration of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines

Enrollment: 82 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe crow's feet lines
• Female or male, 18 to 65 years of age and in good general health
• Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study

Exclusion criteria

• Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A
• Muscle weakness or paralysis, particularly in the area receiving study treatment
• Active skin disease or irritation at the treatment area
• Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
• Treatment with Botulinum Toxin Type A for crow's feet lines in the last 6 months or 3 months anywhere in the body

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups, including a placebo group

Dose B

Placebo Comparator group

Description:

Dose B: Placebo

Treatment:

Drug: Placebo

Dose A

Experimental group

Description:

Dose A: Botulinum Toxin Type A

Treatment:

Drug: Botulinum Toxin Type A