Safety and Efficacy of the Use of Botox on Acne

• ClinicalTrials.gov Identifier: NCT00765375
• Recruitment Status: Terminated
• First Posted: October 2, 2008
• Results First Posted: April 30, 2015
• Last Update Posted: June 29, 2018
• Sponsor: DeNova Research
• Information provided by (Responsible Party): Steven H. Dayan, DeNova Research

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: Botulinum Neurotoxin Type A; Drug: Bacteriostatic saline	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, 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
• Study Start Date: September 2008
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Botox and Placebo on each side of face; Botulinum Neurotoxin Type A (Botox, 1.5-3 units/lesion); Bacteriostatic saline solution (0.11 cc/lesion)	Drug: Botulinum Neurotoxin Type A; 1.5-3 units of Botox/lesion; Other Name: Botox; Drug: Bacteriostatic saline; .1 cc bacteriostatic saline/lesion

Outcome Measures

Primary Outcome Measures :

1. Change in Mean Lesion Count From Baseline at 90 Days [ Time Frame: Baseline and 90 days ]
   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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Steven H. Dayan, Medical Director, DeNova Research
• ClinicalTrials.gov Identifier: NCT00765375
• Other Study ID Numbers: BTX-D-001
• First Posted: October 2, 2008
• Results First Posted: April 30, 2015
• Last Update Posted: June 29, 2018
• Last Verified: May 2018

Keywords provided by Steven H. Dayan, DeNova Research:

acne; Botox; cosmetic treatments

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Botulinum Toxins, Type A; abobotulinumtoxinA; Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents