Safety and Efficacy of the Use of Botox on Acne



Status:Terminated
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 50
Updated:7/1/2018
Start Date:September 2008
End Date:December 2008

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Double-Blind, Randomized, Placebo-Controlled Study to Determine the Safety and the Efficacy of Using Botulinum Neurotoxin Type A Injections for Subjects With Mild to Moderate Acne Vulgaris

• 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)

• 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. Patient will complete a subject evaluation at each visit. Follow-up visits occur
at Day 3, 7, 14, 30 and 90.

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
We found this trial at
1
site
845 North Michigan Ave
Chicago, Illinois 60611
312-335-2070
?
mi
from
Chicago, IL
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