Safety and Efficacy of the Use of Botox on Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Botulinum Neurotoxin Type A; Bacteriostatic saline
Intervention description: 1.5-3 units of Botox/lesion; .1 cc bacteriostatic saline/lesion
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: acne; Botox; cosmetic treatments

Summary:

      • To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate
      acne vulgaris defined by the Investigator's Global Assessment (IGA)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between the age of 18 and 50 years of age

          -  Not pregnant and negative pregnancy test, not planning on getting pregnant

          -  Mild to moderate bilateral acne lesions on the face

          -  Able to understand the requirements of the study and sign an Informed Consent Form

          -  Have the time and ability to complete the study and comply with instructions(i.e will
             be around for the duration of the study)

          -  Skin types I, II, III, IV and V

        Exclusion Criteria:

          -  Subject has skin type VI

          -  Subject has a significant concurrent illness, such as diabetes, epilepsy, lupus or
             congestive heart disease

          -  Concurrent skin conditions affecting area to be treated

          -  Prior exposure to any serotype of botulinum toxin for any purpose in the 3 months
             immediately prior to study enrollment

          -  Prior surgery on the area to be treated within 3 months of initial treatment or during
             this clinical evaluation

          -  Open laceration, abrasion active cold sores or herpes sores, multiple dysplastic nevi
             in areas to be treated?

          -  Permanent or semi-permanent dermal filler treatment within the last 6 months

          -  Medium or deep depth chemical peel resurfacing procedure within 3 months of treatment
             or during this clinical evaluation

          -  Has used oral isotretinoin (Accutane) within 6 months, or use of topical isotretinoin
             within 3 months, of initial treatment or during this clinical evaluation

          -  Prior light /laser treatments at target locations within 3 months of enrollment or
             during the course of this clinical evaluation

          -  Any physical or mental condition which, in the investigator's opinion would make it
             unsafe for the subject to participate in the clinical evaluation

          -  Use of oral antibiotics for acne and/or medication that cause photosensitivity within
             2 weeks of initial treatment

          -  Participation in a study of another investigational devices or drugs within 3 months
             of enrollment

          -  Subject shows symptoms of a hormonal disorder

          -  Subject cannot be treated for (past or present) any form of treatment of active cancer
             or having a history of skin cancer or any other cancer in the area to be treated

          -  Subject is currently using immunosuppressive medications