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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, also known as Crow's Feet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle | Placebo Comparator | Vehicle |
|
| ET-01 345U | Experimental | botulinum toxin, Type A, Dose 1, 345 U |
|
| ET-01 1100U | Experimental | botulinum toxin, Type A, Dose 2, 1100 U |
|
| 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 |
|---|---|---|---|---|---|---|
| Baumann Cosmetic & Research Institute | Miami | Florida | 33137 | United States | ||
| Synexus, Inc. |
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A total of N=88 subjects were screened; N=75 were found eligible and were randomized and treated.
Participants were recruited from five medical centers between October 2018 and March 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle | Vehicle Vehicle: Vehicle Formulation |
| FG001 | ET-01 345U | botulinum toxin, Type A, Dose 1, 345U lower dose of botulinum toxin, Type A: topical liniment |
| FG002 | ET-01 1100U | botulinum toxin, Type A, Dose 2, 1100U higher dose of botulinum toxin, Type A: topical liniment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle | Vehicle Vehicle: Vehicle Formulation |
| BG001 | ET-01 345U | botulinum toxin, Type A, Lower Dose 1, 345U 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 had at least one post-baseline visit. 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 Vehicle: Vehicle Formulation | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Murphy | Clinical Research Management Group | 4138210022 | 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 | Sep 6, 2018 | 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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sequential cohort, dose escalating study
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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 Time Between Week 4 and Week 12 | Total number of observations with a change by at least two ordinals in the Subjects 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 an improvement ≥ 2 score points. The observation period covers the time time of expected peak efficacy from Week 4 to Week 12. | Week 4, 8,and 12 |
| Pinellas Park |
| Florida |
| 33781 |
| United States |
| Forefront Dermatology | Louisville | Kentucky | 40202 | United States |
| Westlake Dermatology Clinical Research Center | Austin | Texas | 78746 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| subject moved out of the area |
|
| BG002 | ET-01 1100U | botulinum toxin, Type A, Higher Dose 2, 1100U botulinum toxin, Type A: topical liniment |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 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. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). | Mean | Standard Deviation | units on a scale |
|
botulinum toxin, Type A, Dose 1
botulinum toxin, Type A: topical liniment
| OG002 | ET-01 1100U | botulinum toxin, Type A, Dose 2 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. | 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 |
|
|
|
| Secondary | Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Time Between Week 4 and Week 12 | Total number of observations with a change by at least two ordinals in the Subjects 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 an improvement ≥ 2 score points. The observation period covers the time time of expected peak efficacy from Week 4 to Week 12. | 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 4, 8,and 12 | Observations | Observations |
|
|
|
| 25 |
| 0 |
| 25 |
| 13 |
| 25 |
| EG001 | ET-01 345U | botulinum toxin, Type A, Lower Dose 1, 345U botulinum toxin, Type A: topical liniment | 0 | 30 | 0 | 30 | 4 | 30 |
| EG002 | ET-01 1100U | botulinum toxin, Type A, Higher Dose 2, 1100U botulinum toxin, Type A: topical liniment | 0 | 20 | 0 | 20 | 5 | 20 |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cough | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cystitis | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ear infection | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
|
| Endodontic procedure | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Endometrial ablation | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Headache | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hordeolum | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Mammoplasty | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
|
| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nausea | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rhinitis allergic | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Thyroiditis subacute | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Upper respiratory tract infection | 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 |