Open Label Study to Assess Long-term Safety of Repeat Administration of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

Revance Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Skin Aging

Treatments: Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01818076

RT001-CL023

Details and patient eligibility

About

This study will evaluate the long-term safety of botulinum toxin type A for the treatment of moderate to severe crow's feet lines after repeat application.

Enrollment: 311 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe crow's feet lines
• Female or male, 18 years of age and above and in good general health
• Women of childbearing potential 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 3 months
• Chemical peel during the 9 months prior to treatment
• Use of prescription retinoid products during the 3 months prior to treatment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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311 participants in 1 patient group

Dose A

Experimental group

Description:

Dose A: Botulinum toxin type A

Treatment:

Drug: Botulinum Toxin Type A