Safety and Efficacy of the Use of Botox on Acne - Full Text View

Sponsor:	DeNova Research
Information provided by:	DeNova Research
ClinicalTrials.gov Identifier:	NCT00765375

Purpose

• 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)

Condition	Intervention	Phase
Acne Vulgaris	Drug: Botulinum Neurotoxin Type A Drug: Bacteriostatic saline	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Acne Botox

Drug Information available for: Botulinum toxin A

U.S. FDA Resources

Further study details as provided by DeNova Research:

Primary Outcome Measures:

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) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	September 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Botulinum Neurotoxin Type A (Botox)	Drug: Botulinum Neurotoxin Type A 1.5-3 units of Botox/lesion Other Name: Botox
Placebo Comparator: 2 Saline Solution	Drug: Bacteriostatic saline .1 cc bacteriostatic saline/lesion

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

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765375

Locations

United States, Illinois
DeNova Research
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

DeNova Research

Investigators

Principal Investigator:

Steven H Dayan, MD F.A.C.S.

DeNova Research

More Information

No publications provided

Responsible Party:	Steven H. Dayan, MD FACS, DeNova Research
ClinicalTrials.gov Identifier:	NCT00765375 History of Changes
Other Study ID Numbers:	BTX-D-001
Study First Received:	September 30, 2008
Last Updated:	October 19, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by DeNova Research:

acne
Botox
cosmetic treatments

Additional relevant MeSH terms:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012