Safety and Efficacy of the Use of Botox on Acne

NCT ID: NCT00765375

Last Updated: 2018-06-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2008-12-31

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Botulinum Neurotoxin Type A

Intervention Type: DRUG

1.5-3 units of Botox/lesion

Bacteriostatic saline

Intervention Type: DRUG

.1 cc bacteriostatic saline/lesion

Interventions

Botulinum Neurotoxin Type A

1.5-3 units of Botox/lesion

Intervention Type: DRUG

Bacteriostatic saline

.1 cc bacteriostatic saline/lesion

Intervention Type: DRUG

Other Intervention Names

Botox

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DeNova Research

OTHER

Sponsor Role: lead

Responsible Party

Steven H. Dayan

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

DeNova Research

Locations

DeNova Research

Chicago, Illinois, United States

Countries

United States

Other Identifiers

BTX-D-001

Identifier Type: -

Identifier Source: org_study_id