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

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This is a safety and efficacy study of botulinum toxin type A in subjects with lateral
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
We found this trial at
1
site
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mi
from
Coral Gables, FL
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