Safety and Efficacy of the Use of Botox on Acne

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DeNova Research
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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