Safety and Efficacy of the Use of Botox on Acne

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00765375
• Other study ID #: BTX-D-001
• Status: Terminated
• Phase: Phase 2
• Start date: September 2008
• Est. completion date: December 2008

Study information

• Verified date: May 2018
• Source: DeNova Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Botulinum Neurotoxin Type A
1.5-3 units of Botox/lesion
• Bacteriostatic saline
.1 cc bacteriostatic saline/lesion

Locations

Country	Name	City	State
United States	DeNova Research	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
DeNova Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Lesion Count From Baseline at 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)	Baseline and 90 days