Acne Vulgaris
Conditions
Keywords
acne, Botox, cosmetic treatments
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.
Interventions
1.5-3 units of Botox/lesion
.1 cc bacteriostatic saline/lesion
Sponsors
DeNova Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Lesion Count From Baseline at 90 Days | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active on One Side and Placebo on the Other Side of Face Botulinum Neurotoxin Type A (Botox) on one side of face, and bacteriostatic saline solution on the other side of face. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Active on One Side and Placebo on the Other Side of Face |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 21 years STANDARD_DEVIATION 2.236 |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
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)
Time frame: Baseline and 90 days
Population: All subjects completing Day 90 visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1- Active | Change in Mean Lesion Count From Baseline at 90 Days | 18.8 Lesions | Standard Deviation 7.33 |
| 2- Placebo | Change in Mean Lesion Count From Baseline at 90 Days | 15.8 Lesions | Standard Deviation 9.52 |