Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A
Condition: Wrinkles
Intervention: Botulinum Toxin; Chemical Peel Only
Intervention description: The botulinum toxin will be injected into the wrinkles "crow's feet". The injections will take about 10 minutes to complete.; After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution [a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)] will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel [35% Trichloroacetic acid] will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.
Intervention MeSH terms: Botulinum Toxins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is being done to find out if the use of botulinum toxin prior to a medium strength
      combination chemical peel (Jessner's peel followed by 35% Trichloroacetic acid peel) will
      improve the appearance of crow's feet wrinkles when compared to a chemical peel alone.
      Botulinum toxin type A is a purified substance, derived from a bacteria that block muscular
      nerve signals. Jessner's Peel, a combination of resorcinol (14g), salicylic acid (14g), and
      lactic acid (85%) in ethanol (95%), is a superficial chemical peel. These two
      products/procedures have been FDA approved to improve the appearance of facial wrinkles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 30 to 75 years old

          -  In good health

          -  Has static and dynamic lateral canthal wrinkles ("crow's feet")

          -  Has the willingness and the ability to understand and provide informed consent and
             communicate with the investigator

        Exclusion Criteria:

          -  Pregnant or lactating

          -  Has received the following treatments:

               -  botulinum toxin injections in the past 6 months

               -  ablative laser procedure in the past 6 months

               -  radiofrequency device treatment in the past 6 months

               -  ultrasound device treatment in the past 6 months

               -  medium to deep chemical peel in the past 6 months

               -  temporary soft tissue augmentation material in the past year

               -  semi-permanent soft tissue augmentation material in the past 2 years

               -  permanent soft tissue augmentation material

          -  Is planning to receive within the next 3 months, any cosmetic procedure (such as any
             chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures,
             filler injections, radiofrequency procedures, dermabrasion, ultrasound and face
             lifting procedures)

          -  Has an active infection on their face (excluding mild acne

          -  Has a history of neuromuscular disorders

          -  Has an allergy to albumin

          -  Has an allergy to Aquaphor AND petroleum jelly

          -  Has a history of bleeding disorders

          -  Is unable to understand the protocol or to give informed consent

          -  Has a mental illness