Botulinum Toxin A Single Blind Split-Face Randomized Pilot Study
Condition: Facial Rhytids
MeSH terms: Facies
Intervention: onabotulinumtoxinA; abobotulinumtoxinA
Intervention description: OnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered as per normal practice.; AbobotulinumtoxinA (Dysport; Galderma) was approved by the FDA in 2009. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered as per normal practice.
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 10.0
Sex: All
Minimum age: 35 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: botulinum toxin type A, intradermal

Summary:

      A 16-week single-blind, split-face, randomized study. Each patient served as their own
      control, receiving onabotulinumtoxinA and abobotulinumtoxinA randomized to either the left or
      right side of the face. Patients received intradermal BTXA injections at week 0 and
      intramuscular BTXA injections at week 2. The objective is to examine the effectiveness of
      intradermal botulinum toxin type A (BTXA) injection in improving skin texture and midface
      lift while reducing pore size and sebum production, as well as investigate the differences in
      effectiveness between onabotulinumtoxinA and abobotulinumtoxinA using intradermal and
      intramuscular injection methods.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects between ages of 35 to 65 years (inclusive) who exhibit static wrinkles
             in the following areas: glabella (forehead frowns), periorbital area (crows feet).
             Static wrinkles in additional areas of the face are also acceptable.

          -  Subject is willing to maintain the same skin care regimen throughout the study and has
             already maintained this skin care regime for 4 weeks prior to baseline.

          -  The subject is able to comply with study procedures and instructions and is committed
             to attend all study visits within the given timelines.

          -  Subject is judged to be a good candidate by study nurse upon identification of dynamic
             and/or static wrinkles in the areas of movement, and with a moderate amount of skin
             laxity.

          -  Subject is willing to use contraception

          -  A signed informed consent form by a subject able to give consent, prior to any study
             procedures are performed.

        Exclusion Criteria:

          -  Sensitivity and/or contraindications to botulinum toxin A other ingredients contained
             in the botulinum toxin A products.

          -  Any medical condition, in the opinion of the investigator, that would interfere with
             safety or any study procedures (e.g. auto-immune disease, history of severe allergies,
             hypertrophic scars, immunotherapeutic treatment, inflammatory or infectious complaints
             at injection sites, unable to give consent)

          -  Treatment with botulinum toxin A injections in the neck or face within 1 year of
             baseline treatment

          -  Treatment with facial fillers less than 1 year prior to baseline

          -  Females of childbearing potential who are pregnant, breastfeeding or plan to get
             pregnant during the course of the study.

          -  Previous treatment with Lasers, Ultrasound Technology or Radio Frequency on the face
             and/or neck within 1 year prior to baseline.

          -  Treatment with Accutane (isotretinoin) or other oral medications for acne during 1
             year prior to baseline.

          -  The use of anti-aging products containing retinol

          -  Known allergy to cow's milk protein