Status:
TERMINATED
Safety and Efficacy of the Use of Botox on Acne
Lead Sponsor:
DeNova Research
Conditions:
Acne Vulgaris
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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)
Detailed Description
• 90 day trial, with botox being injected at baseline/screening visit. Photos will be taken throughout the study and patients will be evaluated by masked injector evaluator and a masked evaluator. Pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00765375
Start Date
September 1 2008
End Date
December 1 2008
Last Update
June 29 2018
Active Locations (1)
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1
DeNova Research
Chicago, Illinois, United States, 60611