Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines
Status: | Active, not recruiting |
---|---|
Conditions: | Cosmetic |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 8/4/2016 |
Start Date: | September 2015 |
End Date: | August 2016 |
This is a safety and efficacy study of botulinum toxin type A in subjects with lateral
canthal lines.
canthal lines.
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
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