Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines (REALISE 1)

Revance Therapeutics

Status and phase

Completed

Phase 3

Conditions

Skin Aging

Treatments

Biological: Botulinum toxin type A

Biological: Placebo comparator

Study type

Interventional

Funder types

Industry

Identifiers

RT001-CL038

Details and patient eligibility

About

This is a safety and efficacy study of botulinum toxin type A in subjects with lateral canthal lines.

Enrollment

450 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

In good general health
Moderate to severe lateral canthal lines when evaluated at rest based on the investigator's global assessment
Moderate to severe lateral canthal lines when evaluated at rest based on the patient assessment of severity

Exclusion criteria

Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
Muscle weakness or paralysis, particularly in the area receiving study treatment
Active skin disease or irritation or disrupted barrier at the treatment area
Active eye disease or irritation
Eyelid ptosis, excessive dermatochalasis, deep dermal scarring, or inability to substantially effect the LCL to be treated by manually spreading the skin apart
Use of topical prescription retinoid product(s) in the lateral canthal areas during the 3 months prior to Screening
Undergone any procedures that may affect the lateral canthal region during the 12 months prior to Screening
Treatment with botulinum toxin type A in the lateral canthal areas in the 6 months prior to Screening or 3 months anywhere else in the body