Safety and Efficacy of the Use of Botox on Acne

May 30, 2018 updated by: Steven H. Dayan, DeNova Research

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

• 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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • Botox
Drug: Bacteriostatic saline
.1 cc bacteriostatic saline/lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DeNova Research

Investigators

  • Principal Investigator: Steven H Dayan, MD F.A.C.S., DeNova Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

October 1, 2008

First Posted (ESTIMATE)

October 2, 2008

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2018

Last Update Submitted That Met QC Criteria

May 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTX-D-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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