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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 / Placebo formulation |
|
| Dose 1 | Experimental | lower dose of ET-01 |
|
| Dose 2 | Experimental | higher dose of ET-01 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vehicle | Biological | Vehicle Formulation |
| |
| botulinum toxin, Type A |
| 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 IGA-C Score ≤ 2 at Any Time Between Week 2 and Week 18 | Total number of observations with a Score of ≤ 2 on the Investigators Global Assessment on Contraction, IGA-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 Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Theobald, MD, PhD | Eirion Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baumann Cosmetic & Research Institute | Miami | Florida | 33137 | United States | ||
| Radiant Research, Inc. |
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A total of N=104 subjects were screened; N=80 were found eligible; N=1 subject withdrew consent prior to treatment assignment; N=79 were randomized.
Participants were recruited from six medical centers between August and October 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle | Vehicle / Placebo formulation Vehicle: Vehicle Formulation, administered once, topically, at Baseline |
| FG001 | Dose 1 | lower dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline |
| FG002 | Dose 2 | higher dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle | Vehicle / Placebo formulation Vehicle: Vehicle Formulation, administered once, topically, at Baseline |
| BG001 | Dose 1 | lower dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline |
| 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 / Placebo formulation Vehicle: Vehicle Formulation | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental death | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment | Death by gunshot wound. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Executive Officer | Eirion Therapeutics | (781) 935-1216 | info@eirionthera.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 | Aug 6, 2018 | Dec 16, 2021 | 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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parallel dose groups
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different doses are packaged in identical containers
| Biological |
botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline |
|
|
| botulinum toxin, Type A | Biological | botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline |
|
|
| Week 2, 4, 8,12, and 18 |
| Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 at Any Time Between Week 2 and Week 18 | Total number of observations with a Score of ≤ 2 on 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 Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18. | Week 2, 4, 8,12, and 18 |
| Pinellas Park |
| Florida |
| 33781 |
| United States |
| Research Institute of the Southeast, LLC | West Palm Beach | Florida | 33401 | United States |
| Dermatology NOLA Inc. | Metairie | Louisiana | 70006 | United States |
| Westlake Dermatology Clinical Research Center | Austin | Texas | 78746 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Dose 2 | higher dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, Dose 2, administered once, topically, at Baseline |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 |
|
lower dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline |
| OG002 | Dose 2 | higher dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline |
|
|
| Secondary | Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 at Any Time Between Week 2 and Week 18 | Total number of observations with a Score of ≤ 2 on the Investigators Global Assessment on Contraction, IGA-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 Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18. | 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 2, 4, 8,12, and 18 | Observations | Observations |
|
|
|
| Secondary | Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 at Any Time Between Week 2 and Week 18 | Total number of observations with a Score of ≤ 2 on 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 Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18. | 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 2, 4, 8,12, and 18 | Observations | Observations |
|
|
|
| 26 |
| 0 |
| 26 |
| 4 |
| 26 |
| EG001 | Dose 1 | lower dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, Dose 1 | 0 | 26 | 0 | 26 | 3 | 26 |
| EG002 | Dose 2 | higher dose of ET-01 botulinum toxin, Type A: botulinum toxin, Type A, Dose 2 | 1 | 27 | 3 | 27 | 2 | 27 |
|
| Bronchitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Depression | Nervous system disorders | MedDRA (21.0) | Systematic Assessment | worsening of pre-existing condition. |
|
| Large intestine benign neoplasm | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue 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 |