Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle | Placebo Comparator | Vehicle |
|
| Dose 1 | Experimental | botulinum toxin, Type A, Dose 1 |
|
| Dose 2 | Experimental | botulinum toxin, Type A, Dose 2 |
|
| Dose 3 | Experimental | botulinum toxin, Type A, Dose 3 |
|
| Dose 4 | Experimental | botulinum toxin, Type A, Dose 4 |
|
| 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 IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2 | Composite of Investigators Global Assessment & Subject Self-Assessment on contraction. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). The same scale is used for the Investigator's Assessment as well as the Subject's Self Assessment. To count, both assessments (on contraction) have to be "responders" defined as Score ≤ 2. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Klaus Theobald, MD, PhD | Eirion Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cary Skin Care | Cary | North Carolina | 27519 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle | Vehicle Vehicle: Vehicle Formulation |
| FG001 | Dose 1 | botulinum toxin, Type A, topical liniment Dose 1x on Day 0 |
| FG002 | Dose 2 | botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0 |
| FG003 | Dose 3 | botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0 |
| FG004 | Dose 4 | botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle | Vehicle Vehicle: Vehicle Formulation |
| BG001 | Dose 1 | botulinum toxin, Type A, topical liniment Dose 1x on Day 0 |
| 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 IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2 | Composite of Investigators Global Assessment & Subject Self-Assessment on contraction. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). The same scale is used for the Investigator's Assessment as well as the Subject's Self Assessment. To count, both assessments (on contraction) have to be "responders" defined as Score ≤ 2. | Per Protocol (PP) 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
Not provided
Not provided
| 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 13.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Executive Officer | Eirion Therapeutics | (781) 935-1216 | info@eirionthera.com |
Not provided
| 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 | Apr 23, 2018 | Jun 29, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
sequential, dose escalating study
Not provided
Not provided
Not provided
| Vehicle | Biological | Vehicle Formulation |
|
| Week 2, 4, 8,12,18 |
| Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 | Total number of observations with a Score of ≤ 2 on 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 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, 8,12,18 |
| BG002 | Dose 2 | botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0 |
| BG003 | Dose 3 | botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0 |
| BG004 | Dose 4 | botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0 |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
| OG001 |
| Dose 1 |
botulinum toxin, Type A, topical liniment Dose 1x on Day 0 |
| OG002 | Dose 2 | botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0 |
| OG003 | Dose 3 | botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0 |
| OG004 | Dose 4 | botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0 |
|
|
| Secondary | Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 | 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. | Per Protocol (PP) 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, 8,12,18 | Observations | Observations |
|
|
|
| Secondary | Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 | Total number of observations with a Score of ≤ 2 on 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 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. | Per Protocol (PP) 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, 8,12,18 | Observations | Observations |
|
|
|
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Dose 1 | botulinum toxin, Type A, topical liniment Dose 1x on Day 0 | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Dose 2 | botulinum toxin, Type A, topical liniment Dose 1.8x on Day 0 | 0 | 9 | 0 | 9 | 1 | 9 |
| EG003 | Dose 3 | botulinum toxin, Type A, topical liniment Dose 2.5x on Day 0 | 0 | 9 | 0 | 9 | 0 | 9 |
| EG004 | Dose 4 | botulinum toxin, Type A, topical liniment Dose 3.5x on Day 0 | 0 | 8 | 0 | 8 | 1 | 8 |
| Myocardial infarction | Cardiac disorders | MedDRA, version 13.1 | Systematic Assessment | PRIOR MYOCARDIAL INFARCTION NOTED ON ECG PRIOR TO STUDY DRUG ADMINISTRATION. CONFIRMED AT WEEK 2 ECG. |
|
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 |
| Observations |
|
| Observations |
|