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Safety and Efficacy of the Use of Botox on Acne

Primary Purpose

Acne Vulgaris

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Botulinum Neurotoxin Type A

Bacteriostatic saline

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne, Botox, cosmetic treatments

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

DeNova Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Botox and Placebo on each side of face

Arm Description

Botulinum Neurotoxin Type A (Botox, 1.5-3 units/lesion); Bacteriostatic saline solution (0.11 cc/lesion)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT00765375

First Posted

September 30, 2008

Last Updated

May 30, 2018

Sponsor

DeNova Research

1. Study Identification

Unique Protocol Identification Number

NCT00765375

Brief Title

Safety and Efficacy of the Use of Botox on Acne

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 Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Terminated

Why Stopped

Investigator decision

Study Start Date

September 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

DeNova Research

4. Oversight

Data Monitoring Committee

Yes

5. 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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

Keywords

acne, Botox, cosmetic treatments

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantOutcomes Assessor

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Botox and Placebo on each side of face

Arm Type

Experimental

Arm Description

Botulinum Neurotoxin Type A (Botox, 1.5-3 units/lesion); Bacteriostatic saline solution (0.11 cc/lesion)

Intervention Type

Drug

Intervention Name(s)

Botulinum Neurotoxin Type A

Other Intervention Name(s)

Botox

Intervention Description

1.5-3 units of Botox/lesion

Intervention Type

Drug

Intervention Name(s)

Bacteriostatic saline

Intervention Description

.1 cc bacteriostatic saline/lesion

Primary Outcome Measure Information:

Title

Change in Mean Lesion Count From Baseline at 90 Days

Description

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

Baseline and 90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

DeNova Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

DeNova Research

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of the Use of Botox on Acne

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