Alopecia Totalis (AT), Alopecia Universalis (AU)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGVehicle
Vehicle Topical Solution
DRUGATI-50002
ATI-50002 Topical Solution
Sponsors
Aclaris Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to comprehend and willing to sign an Informed Consent Form (ICF). * Male or non-pregnant, non-nursing female ≥18 years old at the time of informed consent. * Have a clinical diagnosis of stable, clinically typical, AU or AT. * Have a duration of the current episode of AU or AT for a minimum of 6 months and a maximum of seven years. * Be willing and able to follow all study instructions and to attend all study visits.
Exclusion criteria
* Females who are nursing, pregnant, or planning to become pregnant for the duration of the study including 30 days after the last application of study medication. * Patchy alopecia areata, diffuse alopecia areata or a history of an atypical pattern of Alopecia Areata (AA) (e.g., ophiasis, sisaihpo). * Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments of efficacy or safety. * Active scalp trauma or other condition affecting the scalp that, in the investigator's opinion, may affect the course of AU or AT or interfere with the study conduct or evaluations. * The presence of a permanent or difficult to remove hairpiece or wig that will, in the opinion of the investigator, interfere with study assessments if not removed at each visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 | Day 2 - Day 29 | ATI-50002 levels in scalp biopsies taken at Visits 3 (Day 2) and 7 (Day 29). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 40 | Baseline - 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. |
| Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 28 | Baseline - 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. |
| Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 28 | Baseline - 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. |
| Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 40 | Baseline - 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. |
| Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 52 | Baseline - 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. |
| Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 28 | Week 4 - 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). |
| Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 40 | Week 4 - 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). |
| Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 52 | Week 4 - 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). |
| Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 28 | Week 4 - 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). |
| Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 40 | Week 4 - 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). |
| Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 52 | Baseline - 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. |
| Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28 | 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. |
| Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40 | 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. |
| Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52 | 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. |
| Open Label Extension: Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 24 From Baseline | Baseline - Week 24 | 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). |
| Open Label Extension: Severity of Alopecia Tool (SALT Scores), Relative Percent Regrowth (%) at Week 40 From Baseline | Baseline - Week 40 | 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). |
| Open Label Extension: The Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 52 From Baseline | Baseline - Week 52 | 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). |
| Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 24 Weeks | Baseline - Week 24 | 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). |
| Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 40 Weeks | Baseline - 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 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). |
| Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 52 Weeks | Baseline - 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 positive percent change over time represents hair regrowth (better outcome). |
| Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 52 | Week 4 - 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Topical Solution Vehicle Topical Solution applied twice daily. | 4 |
| ATI-50002 0.46% Topical Solution ATI-50002 0.46% Topical Solution applied twice daily. | 7 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-blind Period = 28 Days | Withdrawal by Subject | 1 | 0 |
| Open Label Extension = 52 Weeks | Lost to Follow-up | 0 | 1 |
| Open Label Extension = 52 Weeks | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Vehicle Topical Solution | ATI-50002 0.46% Topical Solution | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 5 Participants | 8 Participants |
| Current Clinical Type of Alopecia Totalis | 1 Participants | 3 Participants | 4 Participants |
| Current Clinical Type of Alopecia Universalis | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Fitzpatrick Skin Type I - Always Burns | 0 Participants | 2 Participants | 2 Participants |
| Fitzpatrick Skin Type II - Burns Easily | 3 Participants | 2 Participants | 5 Participants |
| Fitzpatrick Skin Type III - Burns Moderately | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type IV - Burns Minimally | 0 Participants | 1 Participants | 1 Participants |
| Fitzpatrick Skin Type VI - Never Burns | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type V - Rarely Burns | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 7 Participants |
| Region of Enrollment United States | 4 participants | 7 participants | 11 participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 10 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
| Time Since Onset of Current Episode of AU or AT | 145.8 Weeks STANDARD_DEVIATION 128.58 | 218.3 Weeks STANDARD_DEVIATION 122.1 | 191.9 Weeks STANDARD_DEVIATION 123.47 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 7 | 0 / 10 |
| other Total, other adverse events | 1 / 4 | 1 / 7 | 7 / 10 |
| serious Total, serious adverse events | 0 / 4 | 0 / 7 | 1 / 10 |
Outcome results
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).
Time frame: Day 2 - Day 29
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 | V3 - Day 2 | 166.0 ng/g | Standard Deviation 83.44 |
| Vehicle | Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 | V7 - Day 29 | NA ng/g | — |
| Active | Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 | V3 - Day 2 | 579.7 ng/g | Standard Deviation 322.36 |
| Active | Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 | V7 - Day 29 | 5710.0 ng/g | Standard Deviation 3647.87 |
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.
Time frame: Baseline - Week 28
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 28 | -7.1 score on a scale | Standard Deviation 12.71 |
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.
Time frame: Baseline - Week 40
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 40 | -9.5 score on a scale | Standard Deviation 10.66 |
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.
Time frame: Baseline - Week 52
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 52 | -12.0 score on a scale | Standard Deviation 11.58 |
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.
Time frame: Baseline - Week 28
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 28 | -6.1 score on a scale | Standard Deviation 11.91 |
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.
Time frame: Baseline - Week 40
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 40 | -8.8 score on a scale | Standard Deviation 12.84 |
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.
Time frame: Baseline - Week 52
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 52 | -15.0 score on a scale | Standard Deviation 16.21 |
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).
Time frame: Week 4 - Week 28
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 28 | 0.1 score on a scale | Standard Deviation 1.16 |
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).
Time frame: Week 4 - Week 40
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 40 | 0.6 score on a scale | Standard Deviation 1.11 |
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).
Time frame: Week 4 - Week 52
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 52 | 0.8 score on a scale | Standard Deviation 1.19 |
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).
Time frame: Week 4 - Week 28
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 28 | 0.4 score on a scale | Standard Deviation 0.9 |
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).
Time frame: Week 4 - Week 40
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 40 | 0.5 score on a scale | Standard Deviation 1.58 |
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).
Time frame: Week 4 - Week 52
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 52 | 0.6 score on a scale | Standard Deviation 1.38 |
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).
Time frame: Baseline - Week 24
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 24 From Baseline | 6.3 percent change | Standard Deviation 12.14 |
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).
Time frame: Baseline - Week 40
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: Severity of Alopecia Tool (SALT Scores), Relative Percent Regrowth (%) at Week 40 From Baseline | 9.0 percent change | Standard Deviation 13.01 |
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.
Time frame: Week 28
Population: All patients who have a valid assessment at the timepoint being reported are included.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28 | 1: Extremely Satisfied | 0 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28 | 2: Moderately Satisfied | 2 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28 | 3: A little Satisfied | 1 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28 | 4: Neither Satisfied or Dissatisfied | 1 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28 | 5: A little Dissatisfied | 0 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28 | 6: Moderately Dissatisfied | 1 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28 | 7: Extremely Dissatisfied | 3 Participants |
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.
Time frame: Week 40
Population: All patients who have a valid assessment at the timepoint being reported are included.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40 | 1: Extremely Satisfied | 0 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40 | 2: Moderately Satisfied | 2 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40 | 3: A little Satisfied | 0 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40 | 4: Neither Satisfied or Dissatisfied | 1 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40 | 5: A little Dissatisfied | 0 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40 | 6: Moderately Dissatisfied | 0 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40 | 7: Extremely Dissatisfied | 1 Participants |
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.
Time frame: Week 52
Population: All patients who have a valid assessment at the timepoint being reported are included.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52 | 1: Extremely Satisfied | 0 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52 | 2: Moderately Satisfied | 2 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52 | 3: A little Satisfied | 0 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52 | 4: Neither Satisfied or Dissatisfied | 1 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52 | 5: A little Dissatisfied | 0 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52 | 6: Moderately Dissatisfied | 0 Participants |
| Vehicle | Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52 | 7: Extremely Dissatisfied | 1 Participants |
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).
Time frame: Baseline - Week 24
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 24 Weeks | 7.2 percent change | Standard Deviation 12.88 |
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).
Time frame: Baseline - Week 40
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 40 Weeks | 9.6 percent change | Standard Deviation 10.81 |
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).
Time frame: Baseline - Week 52
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 52 Weeks | 12.2 percent change | Standard Deviation 11.74 |
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).
Time frame: Baseline - Week 52
Population: All randomized patients who have a valid assessment at baseline and the subsequent timepoint being reported are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Open Label Extension: The Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 52 From Baseline | 15.5 percent change | Standard Deviation 16.77 |