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This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).
This product is being tested for its ability to reduce lateral canthal lines (LCL), also known as Crow's Feet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle | Placebo Comparator | Vehicle, topical liniment, administered once at baseline |
|
| ET-01 1610U | Experimental | botulinum toxin, Type A, topical liniment, administered once at baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin, Type A | Biological | topical liniment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Response Defined as Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4 | Investigators Global Assessment of the Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). Response is defined as change by at least two ordinals from Baseline to Week 4. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit | Total number of observations with a change in the Investigators Global Assessment on Contraction, IGA-C, and the Subject Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synexis, Inc. | Pinellas Park | Florida | 33781 | United States | ||
| Yardley Dermatology Associates |
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A total of N=45 subjects were screened; N=38 were found eligible; N=7 subjects screen failed prior to treatment assignment; N=38 were randomized
Participants were recruited from three medical centers between February 2019 and October 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle | Vehicle, topical liniment, administered once at baseline Vehicle: Vehicle Formulation |
| FG001 | ET-01 1610U | botulinum toxin, Type A, topical liniment, administered once at baseline botulinum toxin, Type A: topical liniment, 1610U |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle | Vehicle, topical liniment, administered once at baseline Vehicle: Vehicle Formulation |
| BG001 | ET-01 1610U | botulinum toxin, Type A, topical liniment, administered once at baseline botulinum toxin, Type A: topical liniment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With a Response Defined as Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4 | Investigators Global Assessment of the Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). Response is defined as change by at least two ordinals from Baseline to Week 4. | Intent-To-Treat (ITT) population defined as all treated subjects who reached Week 4. No imputation was performed when only incomplete data were available. | Posted | Count of Participants | Participants | Week 4 |
|
26 Weeks
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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 | Vehicle | Vehicle, topical liniment, administered once at baseline Vehicle: Vehicle Formulation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Murphy | Clinical Research Management Group | (866) 337-1868 | p.murphy@crmg-usa.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2019 | May 9, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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vehicle controlled, parallel group
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| Vehicle | Biological | Vehicle Formulation |
|
| Week 1, 2, 4, 8,12,18, and 26 |
| Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Post Baseline Visit | Total number of observations with a change in the Subject Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26. | Week 1, 2, 4, 8,12,18, and 26 |
| Yardley |
| Pennsylvania |
| 19067 |
| United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| IGA-C | Investigator Global Assessment on Contraction using the ordinal Crow's Feet Wrinkle Scale where severity is scored between 0=absent and 4=severe. | Mean | Standard Deviation | units on a scale |
|
| SSA-C | Subject Self-Assessment on Contraction using the ordinal Crow's Feet Wrinkle Scale where severity is scored between 0=absent and 4=severe. | Mean | Standard Deviation | units on a scale |
|
botulinum toxin, Type A, topical liniment, administered once at baseline botulinum toxin, Type A: topical liniment |
|
|
| Secondary | Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit | Total number of observations with a change in the Investigators Global Assessment on Contraction, IGA-C, and the Subject Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26. | Total number of observations with a change in the Investigators Global Assessment on Contraction, IGA-C, and the Subject Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26. | Posted | Count of Units | Observations | Week 1, 2, 4, 8,12,18, and 26 | Observations | Observations |
|
|
|
| Secondary | Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Post Baseline Visit | Total number of observations with a change in the Subject Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26. | Intent-To-Treat (ITT) population defined as all treated subjects who had at least one post-baseline visit. No imputation was performed when only incomplete data were available. | Posted | Count of Units | Observations | Week 1, 2, 4, 8,12,18, and 26 | Observations | Observations |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 6 |
| 19 |
| EG001 | ET-01 1610U | botulinum toxin, Type A, topical liniment, administered once at baseline botulinum toxin, Type A: topical liniment | 0 | 19 | 0 | 19 | 2 | 19 |
| Thermal Burn | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Folliculitis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Endodontic Procedure | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Oral Herpes | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hordeolum | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
Study Results are considered Confidential Information that may not be published or disclosed without Sponsor's written consent for a period of five (5) years after completion of the Study.
| 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 |