Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the efficacy and side effects of Botox and Jeuveau for glabellar lines.
After being informed about the study and potential risks, all patients given consent will receive Botox on one side of their face and Jueveau on the other. A random number generator will generate a list of 20 combinations of "1,2" or "2,1". "1,2" means the Botox (onabotulinumtoxin A) will be placed on the right side and "2,1" means that the Botox will be placed on the left. The other side will be injected with PrabotulinumtoxinA. 8-10 units will be injected into the designated glabella in 3 sites.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Onabotulinumtoxin A | Experimental | 8-10 units of Botox will be injected in the glabellar lines in one side of the face in 3 different locations. This injection will happen once. |
|
| Prabotulinumtoxin A | Experimental | 8-10 units of Jeuveau will be injected in the glabellar lines in the other side of the face in 3 different locations. This injection will happen once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrabotulinumtoxinA | Drug | Glabellar line correction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Movement on a 10 point Frown Movement Scale at 3 weeks | 10-point scale created by the investigator assessing movement of glabellar lines. Possible scores range from 0 (no movement) to 10 (movement). | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Days to onset of neurotoxin | # of days until neurotoxin begins decreasing movement on each side | Up to 2-4 days |
| Bruising from the injection on a scale of 1-10 | Post injection bruising measured on a scale from 0 (no bruising) to 10 (most possible bruising) created by the investigator. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Roski Eye Institute | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30951166 | Background | Rzany BJ, Ascher B, Avelar RL, Bergdahl J, Bertucci V, Bodokh I, Carruthers JA, Cartier H, Delmar H, Denfeld R, Gross JE, Heckmann M, Heden P, Hilton S, Inglefield C, Ogilvie P, Sattler G, Sebastian M, Solish N, Swift A, Trevidic P. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients. Aesthet Surg J. 2020 Mar 23;40(4):413-429. doi: 10.1093/asj/sjz110. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000630868 | prabotulinumtoxin A |
| C000629279 | onabotulinum toxin A |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
The two different neurotoxins will be drawn into identical appearing syringes by an unblinded investigator. The injector will be a blinded investigator and will not know which syringe has which neurotoxin. There is no difference in appearance of the product when in a standardized syringe. The PI and co-investigator will be graders of these images and will be blinded during the grading process.
| Onabotulinum toxin A | Drug | Glabellar line correction |
|
|
| Up to 2-4 days |
| Pain from the injection on a scale of 1-10 | Post injection pain will be measured on a scale from 0 (no pain) to 10 (most possible pain) created by the investigator. | Up to 2-4 days |
| Headache from the injection on a scale of 1-10 | Post injection headache will be measured on a scale from 0 (no pain) to 10 (most possible pain) created by the investigator. | Up to 2-4 days |
| Movement on a 10 point Frown Movement Scale at 3 weeks | Patients grade their own movement of glabellar lines using a 10-point scale created by the investigator. Possible scores range from 0 (no movement) to 10 (movement). | 3 weeks |
| Change in glabellar lines on the Merz Score (0-4) | The Merz Score is a 5 point scale. The Merz Score will be used to grade glabellar lines at rest and frown at both baseline and the 3 week visit. Change will calculated from the 3 week visit compared to baseline. | At baseline and 3 weeks |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |