Safety and Efficacy of the Use of Botox on Acne
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ClinicalTrials.gov Identifier: NCT00765375 |
Recruitment Status :
Terminated
(Investigator decision)
First Posted : October 2, 2008
Results First Posted : April 30, 2015
Last Update Posted : June 29, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris | Drug: Botulinum Neurotoxin Type A Drug: Bacteriostatic saline | Phase 2 |
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 |

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

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765375
United States, Illinois | |
DeNova Research | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Steven H Dayan, MD F.A.C.S. | DeNova Research |
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 Key Record Dates |
Results First Posted: | April 30, 2015 |
Last Update Posted: | June 29, 2018 |
Last Verified: | May 2018 |
acne Botox cosmetic treatments |
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 |