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Therapeutic Areas: Dermatology/Plastic Surgery
Disease Category: Acne

Trial Information

Treatment for Acne

Double-blind, randomized, placebo contolled trial examining the effects of Botox therapy on subjects with mild to moderate acne. Subjects will be treated with Botox or normal saline per lesion on one side of their face for the duration of the study. (90 Days)

Patient Inclusion Criteria

• Between the age of 18 and 50 years of age
• Not pregnant and negative pregnancy test, not planning on getting pregnant
• Has mild to moderate bilateral acne lesions on the face
• Able to understand the requirements of the study and sign an Informed Consent Form
• Subject has 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

PatientExclusionCriteria

• 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 cannot show 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

Selika Borst, MS, RN, Assistant DIrector of Clinical Research
DeNova Research
845 N. Michigan Ave., Suite 923 East
Chicago, IL 60611
Phone: (312) 335-2070
EMail: selika@drdayan.com

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