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A 16-week single-blind, split-face, randomized study. Each patient served as their own control, receiving onabotulinumtoxinA and abobotulinumtoxinA randomized to either the left or right side of the face. Patients received intradermal BTXA injections at week 0 and intramuscular BTXA injections at week 2. The objective is to examine the effectiveness of intradermal botulinum toxin type A (BTXA) injection in improving skin texture and midface lift while reducing pore size and sebum production, as well as investigate the differences in effectiveness between onabotulinumtoxinA and abobotulinumtoxinA using intradermal and intramuscular injection methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm A | Active Comparator | The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. |
|
| Treatment Arm B | Active Comparator | The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| onabotulinumtoxinA | Drug | OnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered as per normal practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 2 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs | Blinded assessments of overall change in facial wrinkles from baseline to week 2 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation >2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings. | Baseline and 2 weeks |
| Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 4 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs | Blinded assessments of overall change in facial wrinkles from baseline to week 4 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation >2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings. | Baseline and 4 weeks |
| Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 16 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs | Blinded assessments of overall change in facial wrinkles from baseline to week 16 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation >2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheetal Sapra, MD, FRCPC | ICLS Dermatology & Plastic Surgery | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28367260 | Derived | Sapra P, Demay S, Sapra S, Khanna J, Mraud K, Bonadonna J. A Single-blind, Split-face, Randomized, Pilot Study Comparing the Effects of Intradermal and Intramuscular Injection of Two Commercially Available Botulinum Toxin A Formulas to Reduce Signs of Facial Aging. J Clin Aesthet Dermatol. 2017 Feb;10(2):34-44. Epub 2017 Feb 1. |
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Photographs of individual participants are included in presentations and publications. Consent to reproduce photographs has been obtained from all participants. No other IPD is planned to be shared unless requested.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm A | The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. onabotulinumtoxinA: OnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead. abobotulinumtoxinA: AbobotulinumtoxinA (Dysport; Galderma) was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across |
| FG001 | Treatment Arm B | The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. onabotulinumtoxinA: OnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead. abobotulinumtoxinA: AbobotulinumtoxinA (Dysport; Galderma) was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm A | The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. OnabotulinumtoxinA was approved by the FDA in 2002. AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered according to normal practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 2 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs | Blinded assessments of overall change in facial wrinkles from baseline to week 2 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation >2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2 weeks |
|
4 months (September 2013-January 2015)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm A | The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. onabotulinumtoxinA: OnabotulinumtoxinA was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead. abobotulinumtoxinA: AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruise | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild severity |
Limitations include small sample size and not having objective assessments. Insignificant p value could mean no difference detected or the sample was too small to detect difference. Blinded assessor made subjective assessments based on the photos.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shantel Demay | ICLS | 905-842-2262 | s.demay@icls.ca |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| abobotulinumtoxinA | Drug | AbobotulinumtoxinA (Dysport; Galderma) was approved by the FDA in 2009. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered as per normal practice. |
|
|
| Baseline and 16 weeks |
| BG001 | Treatment Arm B | The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. OnabotulinumtoxinA was approved by the FDA in 2002. AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered according to normal practice. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Blinded assessment of facial rhytids | 5 point scale. 0=Wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation(0-1mm deep), 4=moderate(1-2mm), 5=deep(>2mm) (maximum). Higher value means a worse outcome (more severe wrinkles). 9 subscales used to obtain 1 score for each patient. Same 5 point scale used for all subscales. Subscales assess different areas of the face. The 9 scales include assessments of the left & right forehead, glabella, around eyes on left & right, left & right cheek, left & right upper lip. Total per patient achieved by taking average of all 9 subscales. | Mean | Full Range | units on a scale |
|
Overall change in wrinkles score. This is calculated per patient, regardless of randomization. |
|
|
|
| Primary | Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 4 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs | Blinded assessments of overall change in facial wrinkles from baseline to week 4 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation >2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 weeks |
|
|
|
|
| Primary | Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 16 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs | Blinded assessments of overall change in facial wrinkles from baseline to week 16 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation >2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 16 weeks |
|
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 3 |
| 5 |
| EG001 | Treatment Arm B | The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. onabotulinumtoxinA: OnabotulinumtoxinA was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead. abobotulinumtoxinA: AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead. | 0 | 5 | 0 | 5 | 5 | 5 |
| Drooping | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild severity |
|
| Dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild severity |
|
| Face flushed | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild severity |
|
| Pain during injection | Nervous system disorders | Non-systematic Assessment | Mild severity |
|
| Acne breakout | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild severity |
|
| Welt on forehead | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild severity |
|
| Stinging sensation on face | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild severity |
|
| Itchiness | Nervous system disorders | Non-systematic Assessment | Mild severity |
|
| Left cheek looks more full | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild severity |
|
| Tension headache | Nervous system disorders | Non-systematic Assessment | Mild severity |
|
| Worsening inflammation at sacroiliac joint | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Mild severity |
|
| Cold | Immune system disorders | Non-systematic Assessment | Mild severity |
|
| Numbness on forehead | Nervous system disorders | Non-systematic Assessment | Mild severity |
|
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| 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 |