Clinical trial NCT00765375: Safety and Efficacy of the Use of Botox on Acne
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: acne
Botox
cosmetic treatments
Lead sponsor: DeNova Research
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Change in Mean Lesion Count From Baseline at 90 Days
timeFrame: Baseline and 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
affiliation: DeNova Research
name: Steven H Dayan, MD F.A.C.S.
role: PRINCIPAL_INVESTIGATOR
References: