Safety and Efficacy of the Use of Botox on Acne

Condition(s) targeted: Acne Vulgaris

Intervention: Botulinum Neurotoxin Type A (Drug); Bacteriostatic saline (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: DeNova Research

Official(s) and/or principal investigator(s):
Steven H Dayan, MD F.A.C.S., Principal Investigator, Affiliation: DeNova Research

Overall contact:
Selika Borst, RN MS, Phone: (312) 335-2070, Email: selika@drdayan.com

- 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)

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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

Selika Borst, RN MS, Phone: (312) 335-2070, Email: selika@drdayan.com

DeNova Research, Chicago, Illinois 60611, United States; Recruiting
Selika N Borst, RN, MS, Phone: 312-335-2070, Email: selika@drdayan.com
Steven H Dayan, MD F.A.C.S., Principal Investigator

Starting date: September 2008
Last updated: October 1, 2008