Safety and Efficacy of the Use of Botox on Acne

DeNova Research

Status and phase

Terminated

Phase 2

Conditions

Acne Vulgaris

Treatments

Drug: Botulinum Neurotoxin Type A

Drug: Bacteriostatic saline

Study type

Interventional

Funder types

Other

Identifiers

NCT00765375

BTX-D-001

Details and patient eligibility

About

• 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)

Full 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.

Enrollment

5 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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