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The primary objective is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution compared to vehicle in subjects with AU and AT.
This study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution in patients with Alopecia Universalis and Alopecia Totalis. Concentrations of ATI-50002 in the blood and skin will be assessed after 28 days of treatment with ATI-50002 Topical Solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle | Placebo Comparator | Vehicle |
|
| Active | Experimental | ATI-50002 Topical Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vehicle | Drug | Vehicle Topical Solution |
| |
| ATI-50002 |
| Measure | Description | Time Frame |
|---|---|---|
| Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 | ATI-50002 levels in scalp biopsies taken at Visits 3 (Day 2) and 7 (Day 29). | Day 2 - Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 52 | The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth. | Baseline - Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aclaris Investigational Site | New York | New York | 10032 | United States | ||
| Aclaris Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle Topical Solution | Vehicle Topical Solution applied twice daily. |
| FG001 | ATI-50002 0.46% Topical Solution | ATI-50002 0.46% Topical Solution applied twice daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Period = 28 Days |
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| Open Label Extension = 52 Weeks |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle Topical Solution | Vehicle Topical Solution applied twice daily. |
| BG001 | ATI-50002 0.46% Topical Solution | ATI-50002 0.46% Topical Solution applied twice daily. |
| 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 | Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 | ATI-50002 levels in scalp biopsies taken at Visits 3 (Day 2) and 7 (Day 29). | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | ng/g | Day 2 - Day 29 |
|
Double blind period = 28 days; Open label extension period = 12 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
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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 Topical Solution | Vehicle Topical Solution applied twice daily during the double blind period of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site erosion | General disorders | MedDRA (22.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marco Cardillo, Clinical Trial Manager | Aclaris Therapeutics, Inc. | 484-540-6299 | mcardillo@aclaristx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 14, 2018 | May 26, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2018 | May 27, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C537055 | Alopecia universalis |
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| Drug |
ATI-50002 Topical Solution |
|
| Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 40 | The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth. | Baseline - Week 40 |
| Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 28 | The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth. | Baseline - Week 28 |
| Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 28 | The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth. | Baseline - Week 28 |
| Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 40 | The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth. | Baseline - Week 40 |
| Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 52 | The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth. | Baseline - Week 52 |
| Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 28 | The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome). | Week 4 - Week 28 |
| Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 40 | The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome). | Week 4 - Week 40 |
| Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 52 | The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome). | Week 4 - Week 52 |
| Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 28 | The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome). | Week 4 - Week 28 |
| Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 40 | The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome). | Week 4 - Week 40 |
| Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 52 | The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome). | Week 4 - Week 52 |
| Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28 | The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata. | Week 28 |
| Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40 | The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata. | Week 40 |
| Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52 | The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata. | Week 52 |
| Open Label Extension: Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 24 From Baseline | The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome). | Baseline - Week 24 |
| Open Label Extension: Severity of Alopecia Tool (SALT Scores), Relative Percent Regrowth (%) at Week 40 From Baseline | The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome). | Baseline - Week 40 |
| Open Label Extension: The Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 52 From Baseline | The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome). | Baseline - Week 52 |
| Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 24 Weeks | The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome). | Baseline - Week 24 |
| Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 40 Weeks | The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome). | Baseline - Week 40 |
| Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 52 Weeks | The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome). | Baseline - Week 52 |
| New York |
| New York |
| 10075 |
| United States |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Fitzpatrick Skin Type | Count of Participants | Participants |
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| Current Clinical Type of Alopecia | Count of Participants | Participants |
|
| Time Since Onset of Current Episode of AU or AT | Mean | Standard Deviation | Weeks |
|
| Units | Counts |
|---|---|
| Participants |
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| Secondary | Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 52 | The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth. | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | score on a scale | Baseline - Week 52 |
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| Secondary | Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 40 | The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth. | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | score on a scale | Baseline - Week 40 |
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| Secondary | Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 28 | The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth. | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | score on a scale | Baseline - Week 28 |
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| Secondary | Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 28 | The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth. | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | score on a scale | Baseline - Week 28 |
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| Secondary | Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 40 | The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth. | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | score on a scale | Baseline - Week 40 |
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| Secondary | Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 52 | The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth. | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | score on a scale | Baseline - Week 52 |
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| Secondary | Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 28 | The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome). | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | score on a scale | Week 4 - Week 28 |
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| Secondary | Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 40 | The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome). | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | score on a scale | Week 4 - Week 40 |
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| Secondary | Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 52 | The Subject Eyebrow Assessment (SEA) is the subject's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The SEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome). | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | score on a scale | Week 4 - Week 52 |
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| Secondary | Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 28 | The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome). | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | score on a scale | Week 4 - Week 28 |
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| Secondary | Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 40 | The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome). | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | score on a scale | Week 4 - Week 40 |
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| Secondary | Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 52 | The Clinician's Eyebrow Assessment (CEA) is the investigator's assessment of the appearance of eyebrow hair present on the affected eyebrow(s) at a particular point in time. The CEA is a five-point VRS ranging from "0 - No eyebrow hair", "1 - A little eyebrow hair", "2 - Some eyebrow hair", "3 - Most eyebrow hair", and "4 - Full eyebrow hair" with a recall period of "right now". A positive change over time represents eyebrow regrowth (better outcome). | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | score on a scale | Week 4 - Week 52 |
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| Secondary | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28 | The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata. | All patients who have a valid assessment at the timepoint being reported are included. | Posted | Count of Participants | Participants | Week 28 |
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| Secondary | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40 | The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata. | All patients who have a valid assessment at the timepoint being reported are included. | Posted | Count of Participants | Participants | Week 40 |
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| Secondary | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52 | The Subject Global Impression of Treatment Satisfaction (SGIS) is a 7-point descriptive scale with a recall period of "right now". The SGIS was completed by subjects during the Open Label period of the study. Scale response options ranged from "1: Extremely Satisfied", "2: Moderately Satisfied", "3: A little Satisfied", "4: Neither Satisfied or Dissatisfied", "5: A little Dissatisfied", "6: Moderately Dissatisfied", or "7: Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied subjects are with the study medication treatment received for their alopecia areata. | All patients who have a valid assessment at the timepoint being reported are included. | Posted | Count of Participants | Participants | Week 52 |
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| Secondary | Open Label Extension: Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 24 From Baseline | The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome). | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | percent change | Baseline - Week 24 |
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| Secondary | Open Label Extension: Severity of Alopecia Tool (SALT Scores), Relative Percent Regrowth (%) at Week 40 From Baseline | The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome). | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | percent change | Baseline - Week 40 |
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| Secondary | Open Label Extension: The Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 52 From Baseline | The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator. A positive percent change over time represents hair regrowth (better outcome). | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | percent change | Baseline - Week 52 |
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| Secondary | Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 24 Weeks | The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome). | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | percent change | Baseline - Week 24 |
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| Secondary | Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 40 Weeks | The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome). | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | percent change | Baseline - Week 40 |
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| Secondary | Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 52 Weeks | The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A positive percent change over time represents hair regrowth (better outcome). | All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included. | Posted | Mean | Standard Deviation | percent change | Baseline - Week 52 |
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| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | ATI-50002 0.46% Topical Solution | ATI-50002 0.46% Topical Solution applied twice daily during the double blind period of the study | 0 | 7 | 0 | 7 | 1 | 7 |
| EG002 | ATI-50002 0.46% Topical Solution OLE | ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study | 0 | 10 | 1 | 10 | 7 | 10 |
| Peripheral swelling | General disorders | MedDRA (22.0) | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
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| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
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| Hypertensive urgency | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
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Not provided
Not provided
| 4: Neither Satisfied or Dissatisfied |
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| 5: A little Dissatisfied |
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| 6: Moderately Dissatisfied |
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| 7: Extremely Dissatisfied |
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| 4: Neither Satisfied or Dissatisfied |
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| 5: A little Dissatisfied |
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| 6: Moderately Dissatisfied |
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| 7: Extremely Dissatisfied |
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| 4: Neither Satisfied or Dissatisfied |
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| 5: A little Dissatisfied |
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| 6: Moderately Dissatisfied |
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| 7: Extremely Dissatisfied |
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