Alopecia Areata
Conditions
Brief summary
Primary: • To assess safety, tolerability and efficacy of 2 dose strengths of ATI-50002 Topical Solution, compared to vehicle in subjects with alopecia areata (AA) Secondary: • To evaluate key clinical outcome assessments
Detailed description
Primary: • To assess safety, tolerability and efficacy of 2 dose strengths of ATI-50002 Topical Solution, compared to vehicle in subjects with alopecia areata (AA) Secondary: • To evaluate key clinical outcome assessments
Interventions
DRUGATI-50002 high dose
Topical solution
DRUGATI-50002 low dose
Topical solution
DRUGPlacebo
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
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have a clinical diagnosis of stable patchy alopecia areata (AA) defined as no current areas of spontaneous regrowth. 2. Have a Severity of Alopecia Tool (SALT) score of at least 15% up to 95% total scalp hair loss determined by the study investigator at baseline. 3. Have a duration of the current episode of scalp hair loss of a minimum of 6 months and a maximum of 12 years. 4. If a woman of childbearing potential (WOCBP), must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2) and agree to: use a highly effective method of birth control for the duration of the study; not be planning a pregnancy during the study duration and use contraception for 30 days after last application of study medication.
Exclusion criteria
1. Females who are nursing, pregnant, or planning to become pregnant for the duration of the study and up to 30 days after the last application of study medication. 2. Diffuse alopecia areata. 3. Concomitant hair loss disorder (by history or physical exam) such as androgenetic alopecia or scarring alopecia (e.g., cicatricial alopecia, frontal fibrosing alopecia, etc.). 4. 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. 5. Active scalp trauma or other condition affecting the scalp that, in the investigator's opinion, may affect the course of AA or interfere with the study conduct or evaluations. 6. 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 |
|---|---|---|
| Percent Change From Baseline in the Severity of Alopecia Tool Score at Week 24 | 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 at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. 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. The primary efficacy variable was the percent change from baseline in SALT score at Week 24. This was calculated as the mean of the changes from Baseline (Visit 2) SALT score to Week 24 (Visit 10) SALT score, divided by Baseline SALT score and expressed as a percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Severity of Alopecia Tool Score at Week 24 | Baseline - Week 24 | 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. |
| Mean Change From Baseline in Alopecia Density and Extent Score at Week 24 | 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 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 negative change in the ALODEX score over time represents hair regrowth. |
| Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Severity of Alopecia Tool Scores at Week 24 | Baseline - Week 24 | A summary of the proportion of subjects in each treatment arm achieving ≥50% hair regrowth compared with baseline using Severity of Alopecia Tool scores at Week 24 is presented. |
| Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Alopecia Density and Extent Scores at Week 24 | Baseline - Week 24 | A summary of the proportion of subjects in each treatment arm achieving ≥50% hair regrowth compared with baseline using Alopecia Density and Extent scores at Week 24 is presented. |
| Proportion of Subjects With ≥2 Point Improvement in Scalp Patient Reported Outcome for Target Patch at Week 24 | Baseline - Week 24 | The Scalp Patient Reported Outcome for Target Patch assesses the appearance of the subject's target patch (identified by the subject as his or her most bothersome area of scalp hair loss at Baseline) and was completed by subjects at Baseline, Week 4, Week 12, and Week 24. The assessment has a recall period of right now and includes a five-point VRS ranging from Full hair, scalp of the target patch completely covered with hair to no hair, scalp of the target patch completely exposed. The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. A summary of the proportion of subjects with ≥2 point improvement in Subject Target Patch assessment at Week 24 compared to baseline is presented. |
| Proportion of Subjects With ≥1 Point Improvement in Scalp Patient Reported Outcome for Entire Scalp at Week 24 | Baseline - Week 24 | The Scalp Patient Reported Outcome for Entire Scalp assesses the appearance of the subject's whole scalp and was completed by subjects at Baseline, Week 4, Week 12, and Week 24. The assessment has a recall period of right now and includes a five-point VRS ranging from Full hair, whole scalp completely covered with hair to no hair, whole scalp completely exposed. The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. A summary of the proportion of subjects with ≥1 point improvement in Subject Entire Scalp assessment at Week 24 compared to baseline is presented. |
| Proportion of Subjects With ≥2-Point Improvement in Scalp Clinician Reported Outcome for Target Patch at Week 24 | Baseline - Week 24 | The Scalp Clinician Reported Outcome for Target Patch provides the investigator's assessment of the appearance of the subject's target patch (identified by the subject as his or her most bothersome area of scalp hair loss at Baseline) and was completed by investigators at Baseline, Week 4, Week 12, and Week 24. The assessment has a recall period of right now and includes a five-point VRS ranging from Full hair, scalp of the target patch completely covered with hair to no hair, scalp of the target patch completely exposed. The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. A summary of the proportion of subjects with ≥2 point improvement in Clinician Target Patch assessment at Week 24 compared to baseline is presented. |
| Percent Change From Baseline in the Alopecia Density and Extent Score at Week 24 | 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 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 negative change in the ALODEX score over time represents hair regrowth. |
| Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Baseline - Week 24 | The Physician Global Impression of Severity (PhGIS) is a 5-point descriptive scale completed by investigators at Baseline, Week 4, Week 12, and Week 24 and is used to capture the investigator's assessment of the subject's disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points. |
| Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Baseline - Week 24 | The Subject Global Impression of Severity (SGIS) is a 5-point descriptive scale completed by subjects at Baseline, Week 4, Week 12, and Week 24 and is used to capture the subject's assessment of disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points. |
| Alopecia Impact Assessment Patient Reported Outcome Change From Baseline at Week 24 | Baseline - Week 24 | The Alopecia Impact Assessment (AIA) is a 13-item patient reported outcome questionnaire which measures the subject's experience with impacts related to alopecia areata in managing appearance, worry, sadness, loss of confidence, self-consciousness, embarrassment, feeling unattractive, limitation of social activities, limitation of physical activities, unwanted attention, sweat in eyes, debris in eyes, and debris in nose. The AIA was completed by subjects at Baseline, Week 4, Week 12, and Week 24 and has a recall period of over the past seven days. An 11-point NRS with anchors 0 - Not at all \[impact\] and 10 - Extremely \[impact\] (e.g., Not at all bothersome and Extremely bothersome; Not at all worried and Extremely worried) is utilized. The AIA produces single-item (0-10) and mean total (0-10) scores, with higher scores indicating higher levels of impact. |
| Subject Global Impression of Treatment Satisfaction at Week 24 | Week 24 | The Subject Global Impression of Treatment Satisfaction (SGITS) is a 7-point descriptive scale completed by subjects at Week 12 and Week 24. Scale response options ranged from 1. Extremely Satisfied to 7. Extremely Dissatisfied and are used to capture how satisfied or dissatisfied they are with the study medication treatment received for their alopecia areata. |
| Change in Dermatology Life Quality Index Total Score Between Baseline and Week 24 | Baseline - Week 24 | The 10 question Dermatology Life Quality Index (DLQI) questionnaire was completed by subjects at Baseline, Week 4, Week 12, and Week 24. When completing the questionnaire, subjects were instructed to think of their hair loss in place of skin problem and skin as referenced in the questionnaire. Possible summary scores could range from 0 to 30 with higher scores indicating a worse outcome. |
| Physician Global Impression of Change at Week 24 | Week 24 | The Physician Global Impression of Change (PhGIC) is a 7-point descriptive scale completed by investigators at Week 24. Scale response options ranged from 1. Very much improved to 7. Very much worse and are used to capture the investigator's overall impression of change for the subject's alopecia during the treatment period. |
| Subject Global Impression of Change at Week 24 | Week 24 | The Subject Global Impression of Change (SGIC) is a 7-point descriptive scale completed by subjects at Week 24. Scale response options ranged from 1. Very much improved to 7. Very much worse and are used to capture the subject's overall impression of change for his/her alopecia during the treatment period. |
| Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Baseline - Week 24 | The Scalp Clinician Reported Outcome for Entire Scalp assesses the appearance of the subject's whole scalp and was completed by investigators at Baseline, Week 4, Week 12, and Week 24. The assessment has a recall period of right now and includes a five-point VRS ranging from Full hair, whole scalp completely covered with hair to no hair, whole scalp completely exposed. The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Topical Solution Vehicle Topical Solution applied twice daily. | 43 |
| ATI-50002 0.12% Topical Solution ATI-50002 0.12% Topical Solution applied twice daily. | 44 |
| ATI-50002 0.46% Topical Solution ATI-50002 0.46% Topical Solution applied twice daily. | 42 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double-blind Period | Adverse Event | 1 | 2 | 0 |
| Double-blind Period | Incomplete Efficacy Data Collection | 1 | 1 | 0 |
| Double-blind Period | Lost to Follow-up | 3 | 4 | 3 |
| Double-blind Period | Protocol Violation | 2 | 0 | 0 |
| Double-blind Period | Withdrawal by Subject | 10 | 6 | 4 |
| Open Label Extension | Adverse Event | 0 | 0 | 1 |
| Open Label Extension | Lack of Efficacy | 0 | 0 | 1 |
| Open Label Extension | Lost to Follow-up | 0 | 0 | 2 |
| Open Label Extension | Physician Decision | 0 | 0 | 1 |
| Open Label Extension | Study Terminated by Sponsor | 0 | 0 | 17 |
| Open Label Extension | Subject Noncompliance | 0 | 0 | 1 |
| Open Label Extension | Withdrawal by Subject | 0 | 0 | 5 |
Baseline characteristics
| Characteristic | Vehicle Topical Solution | ATI-50002 0.12% Topical Solution | ATI-50002 0.46% Topical Solution | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 0 Participants | 2 Participants | 5 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 3 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 40 Participants | 37 Participants | 113 Participants |
| Age, Continuous | 42.0 years STANDARD_DEVIATION 16.58 | 42.1 years STANDARD_DEVIATION 13.92 | 40.5 years STANDARD_DEVIATION 14.99 | 41.5 years STANDARD_DEVIATION 15.09 |
| Duration of Alopecia Areata | 6.9 years STANDARD_DEVIATION 7.92 | 12.9 years STANDARD_DEVIATION 12.25 | 9.9 years STANDARD_DEVIATION 10.43 | 9.9 years STANDARD_DEVIATION 10.59 |
| Duration of Current Episode of Alopecia Areata | 127.8 weeks STANDARD_DEVIATION 104.13 | 160.7 weeks STANDARD_DEVIATION 140.67 | 156.3 weeks STANDARD_DEVIATION 140.95 | 148.3 weeks STANDARD_DEVIATION 129.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 4 Participants | 7 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 26 Participants | 23 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants | 14 Participants | 12 Participants | 38 Participants |
| Fitzpatrick Skin Type I - Always Burns | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Fitzpatrick Skin Type II - Burns Easily | 12 Participants | 16 Participants | 14 Participants | 42 Participants |
| Fitzpatrick Skin Type III - Burns Moderately | 13 Participants | 9 Participants | 9 Participants | 31 Participants |
| Fitzpatrick Skin Type IV - Burns Minimally | 6 Participants | 6 Participants | 8 Participants | 20 Participants |
| Fitzpatrick Skin Type VI - Never Burns | 4 Participants | 3 Participants | 3 Participants | 10 Participants |
| Fitzpatrick Skin Type V - Rarely Burns | 6 Participants | 7 Participants | 6 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 10 Participants | 7 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 32 Participants | 29 Participants | 31 Participants | 92 Participants |
| Region of Enrollment United States | 43 participants | 43 participants | 43 participants | 129 participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 18 Participants | 46 Participants |
| Sex: Female, Male Male | 28 Participants | 31 Participants | 24 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 44 | 0 / 42 | 0 / 59 |
| other Total, other adverse events | 21 / 43 | 19 / 44 | 14 / 42 | 27 / 59 |
| serious Total, serious adverse events | 0 / 43 | 2 / 44 | 0 / 42 | 0 / 59 |
Outcome results
Primary
Percent Change From Baseline in the Severity of Alopecia Tool Score at 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 at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. 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. The primary efficacy variable was the percent change from baseline in SALT score at Week 24. This was calculated as the mean of the changes from Baseline (Visit 2) SALT score to Week 24 (Visit 10) SALT score, divided by Baseline SALT score and expressed as a percentage.
Time frame: Baseline - Week 24
Population: This primary analysis utilized the SALT score with imputation for last observation carried forward (LOCF) and was based on the intent-to-treat population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Topical Solution | Percent Change From Baseline in the Severity of Alopecia Tool Score at Week 24 | -18.54 score on a scale | Standard Error 4.705 |
| ATI-50002 0.12% Topical Solution | Percent Change From Baseline in the Severity of Alopecia Tool Score at Week 24 | -4.66 score on a scale | Standard Error 4.707 |
| ATI-50002 0.46% Topical Solution | Percent Change From Baseline in the Severity of Alopecia Tool Score at Week 24 | -9.22 score on a scale | Standard Error 4.784 |
Comparison: Since this was the first multicenter study evaluating the effect of ATI-50002 Topical Solution in subjects with stable patchy alopecia areata, the sample size was based upon feasibility issues rather than a formal power calculation. Planned data from 120 subjects, utilizing LOCF for missing data, provides 80% power to detect a 24-point difference in percent change from baseline in SALT score between any two treatment groups. This power computation is based upon assumed standard deviation of 38%.p-value: 0.03895% CI: [0.77, 27]Mixed Models Analysis
Comparison: Since this was the first multicenter study evaluating the effect of ATI-50002 Topical Solution in subjects with stable patchy alopecia areata, the sample size was based upon feasibility issues rather than a formal power calculation. Planned data from 120 subjects, utilizing LOCF for missing data, provides 80% power to detect a 24-point difference in percent change from baseline in SALT score between any two treatment groups. This power computation is based upon assumed standard deviation of 38%.p-value: 0.16695% CI: [-3.9, 22.55]Mixed Models Analysis
Secondary
Alopecia Impact Assessment Patient Reported Outcome Change From Baseline at Week 24
The Alopecia Impact Assessment (AIA) is a 13-item patient reported outcome questionnaire which measures the subject's experience with impacts related to alopecia areata in managing appearance, worry, sadness, loss of confidence, self-consciousness, embarrassment, feeling unattractive, limitation of social activities, limitation of physical activities, unwanted attention, sweat in eyes, debris in eyes, and debris in nose. The AIA was completed by subjects at Baseline, Week 4, Week 12, and Week 24 and has a recall period of over the past seven days. An 11-point NRS with anchors 0 - Not at all \[impact\] and 10 - Extremely \[impact\] (e.g., Not at all bothersome and Extremely bothersome; Not at all worried and Extremely worried) is utilized. The AIA produces single-item (0-10) and mean total (0-10) scores, with higher scores indicating higher levels of impact.
Time frame: Baseline - Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Topical Solution | Alopecia Impact Assessment Patient Reported Outcome Change From Baseline at Week 24 | -0.8 score on a scale | Standard Deviation 2.21 |
| ATI-50002 0.12% Topical Solution | Alopecia Impact Assessment Patient Reported Outcome Change From Baseline at Week 24 | -0.8 score on a scale | Standard Deviation 2.26 |
| ATI-50002 0.46% Topical Solution | Alopecia Impact Assessment Patient Reported Outcome Change From Baseline at Week 24 | -1.0 score on a scale | Standard Deviation 2.3 |
Secondary
Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24
The Scalp Clinician Reported Outcome for Entire Scalp assesses the appearance of the subject's whole scalp and was completed by investigators at Baseline, Week 4, Week 12, and Week 24. The assessment has a recall period of right now and includes a five-point VRS ranging from Full hair, whole scalp completely covered with hair to no hair, whole scalp completely exposed. The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Time frame: Baseline - Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vehicle Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Better by 1 points | 11 Participants |
| Vehicle Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Worse by 4 point | 0 Participants |
| Vehicle Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Worse by 1 point | 4 Participants |
| Vehicle Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | No change | 27 Participants |
| Vehicle Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Better by 4 points | 0 Participants |
| Vehicle Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Worse by 3 point | 0 Participants |
| Vehicle Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Better by 2 points | 1 Participants |
| Vehicle Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Better by 3 points | 0 Participants |
| Vehicle Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Worse by 2 point | 0 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | No change | 27 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Better by 4 points | 0 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Better by 3 points | 0 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Better by 2 points | 2 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Better by 1 points | 9 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Worse by 1 point | 5 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Worse by 2 point | 1 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Worse by 3 point | 0 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Worse by 4 point | 0 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Better by 2 points | 2 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Better by 4 points | 0 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Worse by 2 point | 1 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Better by 3 points | 1 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Worse by 4 point | 0 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | No change | 23 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Better by 1 points | 8 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Worse by 3 point | 0 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 | Worse by 1 point | 7 Participants |
p-value: 0.505Wilcoxon (Mann-Whitney)
p-value: 0.359Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24
The Physician Global Impression of Severity (PhGIS) is a 5-point descriptive scale completed by investigators at Baseline, Week 4, Week 12, and Week 24 and is used to capture the investigator's assessment of the subject's disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Time frame: Baseline - Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vehicle Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Better by 1 point | 9 Participants |
| Vehicle Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Worse by 4 points | 0 Participants |
| Vehicle Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Worse by 1 point | 1 Participants |
| Vehicle Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | No change | 27 Participants |
| Vehicle Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Better by 4 points | 0 Participants |
| Vehicle Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Worse by 3 points | 0 Participants |
| Vehicle Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Better by 2 points | 5 Participants |
| Vehicle Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Better by 3 points | 0 Participants |
| Vehicle Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Worse by 2 points | 1 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | No change | 26 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Better by 4 points | 0 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Better by 3 points | 0 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Better by 2 points | 4 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Better by 1 point | 10 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Worse by 1 point | 3 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Worse by 2 points | 1 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Worse by 3 points | 0 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Worse by 4 points | 0 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Better by 2 points | 4 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Better by 4 points | 0 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Worse by 2 points | 1 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Better by 3 points | 0 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Worse by 4 points | 0 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | No change | 19 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Better by 1 point | 12 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Worse by 3 points | 1 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 | Worse by 1 point | 5 Participants |
p-value: 0.602Wilcoxon (Mann-Whitney)
p-value: 0.643Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24
The Subject Global Impression of Severity (SGIS) is a 5-point descriptive scale completed by subjects at Baseline, Week 4, Week 12, and Week 24 and is used to capture the subject's assessment of disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.
Time frame: Baseline - Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vehicle Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Better by 1 point | 9 Participants |
| Vehicle Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Worse by 4 points | 0 Participants |
| Vehicle Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Worse by 1 point | 14 Participants |
| Vehicle Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | No change | 11 Participants |
| Vehicle Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Better by 4 points | 0 Participants |
| Vehicle Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Worse by 3 points | 0 Participants |
| Vehicle Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Better by 2 points | 6 Participants |
| Vehicle Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Better by 3 points | 1 Participants |
| Vehicle Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Worse by 2 points | 2 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | No change | 20 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Better by 4 points | 1 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Better by 3 points | 2 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Better by 2 points | 5 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Better by 1 point | 4 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Worse by 1 point | 8 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Worse by 2 points | 4 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Worse by 3 points | 0 Participants |
| ATI-50002 0.12% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Worse by 4 points | 0 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Better by 2 points | 5 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Better by 4 points | 0 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Worse by 2 points | 1 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Better by 3 points | 3 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Worse by 4 points | 0 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | No change | 17 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Better by 1 point | 9 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Worse by 3 points | 0 Participants |
| ATI-50002 0.46% Topical Solution | Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 | Worse by 1 point | 7 Participants |
p-value: 0.992Wilcoxon (Mann-Whitney)
p-value: 0.257Wilcoxon (Mann-Whitney)
Secondary
Change in Dermatology Life Quality Index Total Score Between Baseline and Week 24
The 10 question Dermatology Life Quality Index (DLQI) questionnaire was completed by subjects at Baseline, Week 4, Week 12, and Week 24. When completing the questionnaire, subjects were instructed to think of their hair loss in place of skin problem and skin as referenced in the questionnaire. Possible summary scores could range from 0 to 30 with higher scores indicating a worse outcome.
Time frame: Baseline - Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Topical Solution | Change in Dermatology Life Quality Index Total Score Between Baseline and Week 24 | -0.5 score on a scale | Standard Deviation 7.64 |
| ATI-50002 0.12% Topical Solution | Change in Dermatology Life Quality Index Total Score Between Baseline and Week 24 | -1.1 score on a scale | Standard Deviation 4.07 |
| ATI-50002 0.46% Topical Solution | Change in Dermatology Life Quality Index Total Score Between Baseline and Week 24 | -2.2 score on a scale | Standard Deviation 5.46 |
Secondary
Mean Change From Baseline in Alopecia Density and Extent Score at 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 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 negative change in the ALODEX score over time represents hair regrowth.
Time frame: Baseline - Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Topical Solution | Mean Change From Baseline in Alopecia Density and Extent Score at Week 24 | -4.91 score on a scale | Standard Error 2.129 |
| ATI-50002 0.12% Topical Solution | Mean Change From Baseline in Alopecia Density and Extent Score at Week 24 | -3.36 score on a scale | Standard Error 2.131 |
| ATI-50002 0.46% Topical Solution | Mean Change From Baseline in Alopecia Density and Extent Score at Week 24 | -4.98 score on a scale | Standard Error 2.165 |
p-value: 0.60795% CI: [-4.39, 7.49]Mixed Models Analysis
p-value: 0.98195% CI: [-6.06, 5.92]Mixed Models Analysis
Secondary
Mean Change From Baseline in Severity of Alopecia Tool Score at Week 24
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 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Topical Solution | Mean Change From Baseline in Severity of Alopecia Tool Score at Week 24 | -6.47 score on a scale | Standard Error 2.071 |
| ATI-50002 0.12% Topical Solution | Mean Change From Baseline in Severity of Alopecia Tool Score at Week 24 | -1.95 score on a scale | Standard Error 2.074 |
| ATI-50002 0.46% Topical Solution | Mean Change From Baseline in Severity of Alopecia Tool Score at Week 24 | -2.94 score on a scale | Standard Error 2.107 |
p-value: 0.12595% CI: [-1.26, 10.3]Mixed Models Analysis
p-value: 0.23495% CI: [-2.3, 9.36]Mixed Models Analysis
Secondary
Percent Change From Baseline in the Alopecia Density and Extent Score at 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 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 negative change in the ALODEX score over time represents hair regrowth.
Time frame: Baseline - Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Topical Solution | Percent Change From Baseline in the Alopecia Density and Extent Score at Week 24 | -14.75 score on a scale | Standard Error 4.508 |
| ATI-50002 0.12% Topical Solution | Percent Change From Baseline in the Alopecia Density and Extent Score at Week 24 | -8.15 score on a scale | Standard Error 4.511 |
| ATI-50002 0.46% Topical Solution | Percent Change From Baseline in the Alopecia Density and Extent Score at Week 24 | -11.52 score on a scale | Standard Error 4.584 |
p-value: 0.30295% CI: [-5.97, 19.17]Mixed Models Analysis
p-value: 0.61695% CI: [-9.44, 15.9]Mixed Models Analysis
Secondary
Physician Global Impression of Change at Week 24
The Physician Global Impression of Change (PhGIC) is a 7-point descriptive scale completed by investigators at Week 24. Scale response options ranged from 1. Very much improved to 7. Very much worse and are used to capture the investigator's overall impression of change for the subject's alopecia during the treatment period.
Time frame: Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vehicle Topical Solution | Physician Global Impression of Change at Week 24 | 2. Much improved | 3 Participants |
| Vehicle Topical Solution | Physician Global Impression of Change at Week 24 | 5. A little worse | 0 Participants |
| Vehicle Topical Solution | Physician Global Impression of Change at Week 24 | 4. No change | 8 Participants |
| Vehicle Topical Solution | Physician Global Impression of Change at Week 24 | 1. Very much improved | 2 Participants |
| Vehicle Topical Solution | Physician Global Impression of Change at Week 24 | 7. Very much worse | 1 Participants |
| Vehicle Topical Solution | Physician Global Impression of Change at Week 24 | 6. Much worse | 1 Participants |
| Vehicle Topical Solution | Physician Global Impression of Change at Week 24 | 3. A little improved | 10 Participants |
| ATI-50002 0.12% Topical Solution | Physician Global Impression of Change at Week 24 | 4. No change | 12 Participants |
| ATI-50002 0.12% Topical Solution | Physician Global Impression of Change at Week 24 | 1. Very much improved | 1 Participants |
| ATI-50002 0.12% Topical Solution | Physician Global Impression of Change at Week 24 | 2. Much improved | 3 Participants |
| ATI-50002 0.12% Topical Solution | Physician Global Impression of Change at Week 24 | 3. A little improved | 7 Participants |
| ATI-50002 0.12% Topical Solution | Physician Global Impression of Change at Week 24 | 5. A little worse | 4 Participants |
| ATI-50002 0.12% Topical Solution | Physician Global Impression of Change at Week 24 | 6. Much worse | 1 Participants |
| ATI-50002 0.12% Topical Solution | Physician Global Impression of Change at Week 24 | 7. Very much worse | 2 Participants |
| ATI-50002 0.46% Topical Solution | Physician Global Impression of Change at Week 24 | 5. A little worse | 4 Participants |
| ATI-50002 0.46% Topical Solution | Physician Global Impression of Change at Week 24 | 2. Much improved | 2 Participants |
| ATI-50002 0.46% Topical Solution | Physician Global Impression of Change at Week 24 | 7. Very much worse | 2 Participants |
| ATI-50002 0.46% Topical Solution | Physician Global Impression of Change at Week 24 | 6. Much worse | 1 Participants |
| ATI-50002 0.46% Topical Solution | Physician Global Impression of Change at Week 24 | 4. No change | 8 Participants |
| ATI-50002 0.46% Topical Solution | Physician Global Impression of Change at Week 24 | 3. A little improved | 9 Participants |
| ATI-50002 0.46% Topical Solution | Physician Global Impression of Change at Week 24 | 1. Very much improved | 6 Participants |
p-value: 0.102Wilcoxon (Mann-Whitney)
p-value: 0.859Wilcoxon (Mann-Whitney)
Secondary
Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Alopecia Density and Extent Scores at Week 24
A summary of the proportion of subjects in each treatment arm achieving ≥50% hair regrowth compared with baseline using Alopecia Density and Extent scores at Week 24 is presented.
Time frame: Baseline - Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vehicle Topical Solution | Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Alopecia Density and Extent Scores at Week 24 | 6 Participants |
| ATI-50002 0.12% Topical Solution | Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Alopecia Density and Extent Scores at Week 24 | 8 Participants |
| ATI-50002 0.46% Topical Solution | Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Alopecia Density and Extent Scores at Week 24 | 8 Participants |
p-value: 0.15795% CI: [0, 2.3]Mixed Models Analysis
p-value: 0.35395% CI: [0.1, 2.8]Mixed Models Analysis
Secondary
Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Severity of Alopecia Tool Scores at Week 24
A summary of the proportion of subjects in each treatment arm achieving ≥50% hair regrowth compared with baseline using Severity of Alopecia Tool scores at Week 24 is presented.
Time frame: Baseline - Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vehicle Topical Solution | Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Severity of Alopecia Tool Scores at Week 24 | 5 Participants |
| ATI-50002 0.12% Topical Solution | Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Severity of Alopecia Tool Scores at Week 24 | 7 Participants |
| ATI-50002 0.46% Topical Solution | Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Severity of Alopecia Tool Scores at Week 24 | 8 Participants |
p-value: 0.6295% CI: [0.4, 4.6]Mixed Models Analysis
p-value: 0.36695% CI: [0.5, 5.8]Mixed Models Analysis
Secondary
Proportion of Subjects With ≥1 Point Improvement in Scalp Patient Reported Outcome for Entire Scalp at Week 24
The Scalp Patient Reported Outcome for Entire Scalp assesses the appearance of the subject's whole scalp and was completed by subjects at Baseline, Week 4, Week 12, and Week 24. The assessment has a recall period of right now and includes a five-point VRS ranging from Full hair, whole scalp completely covered with hair to no hair, whole scalp completely exposed. The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. A summary of the proportion of subjects with ≥1 point improvement in Subject Entire Scalp assessment at Week 24 compared to baseline is presented.
Time frame: Baseline - Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vehicle Topical Solution | Proportion of Subjects With ≥1 Point Improvement in Scalp Patient Reported Outcome for Entire Scalp at Week 24 | 13 Participants |
| ATI-50002 0.12% Topical Solution | Proportion of Subjects With ≥1 Point Improvement in Scalp Patient Reported Outcome for Entire Scalp at Week 24 | 10 Participants |
| ATI-50002 0.46% Topical Solution | Proportion of Subjects With ≥1 Point Improvement in Scalp Patient Reported Outcome for Entire Scalp at Week 24 | 9 Participants |
p-value: 0.43595% CI: [0.3, 1.8]Mixed Models Analysis
p-value: 0.3795% CI: [0.2, 1.7]Mixed Models Analysis
Secondary
Proportion of Subjects With ≥2-Point Improvement in Scalp Clinician Reported Outcome for Target Patch at Week 24
The Scalp Clinician Reported Outcome for Target Patch provides the investigator's assessment of the appearance of the subject's target patch (identified by the subject as his or her most bothersome area of scalp hair loss at Baseline) and was completed by investigators at Baseline, Week 4, Week 12, and Week 24. The assessment has a recall period of right now and includes a five-point VRS ranging from Full hair, scalp of the target patch completely covered with hair to no hair, scalp of the target patch completely exposed. The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. A summary of the proportion of subjects with ≥2 point improvement in Clinician Target Patch assessment at Week 24 compared to baseline is presented.
Time frame: Baseline - Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vehicle Topical Solution | Proportion of Subjects With ≥2-Point Improvement in Scalp Clinician Reported Outcome for Target Patch at Week 24 | 6 Participants |
| ATI-50002 0.12% Topical Solution | Proportion of Subjects With ≥2-Point Improvement in Scalp Clinician Reported Outcome for Target Patch at Week 24 | 10 Participants |
| ATI-50002 0.46% Topical Solution | Proportion of Subjects With ≥2-Point Improvement in Scalp Clinician Reported Outcome for Target Patch at Week 24 | 9 Participants |
p-value: 0.33395% CI: [0.6, 5.4]Mixed Models Analysis
p-value: 0.38895% CI: [0.5, 5.2]Mixed Models Analysis
Secondary
Proportion of Subjects With ≥2 Point Improvement in Scalp Patient Reported Outcome for Target Patch at Week 24
The Scalp Patient Reported Outcome for Target Patch assesses the appearance of the subject's target patch (identified by the subject as his or her most bothersome area of scalp hair loss at Baseline) and was completed by subjects at Baseline, Week 4, Week 12, and Week 24. The assessment has a recall period of right now and includes a five-point VRS ranging from Full hair, scalp of the target patch completely covered with hair to no hair, scalp of the target patch completely exposed. The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. A summary of the proportion of subjects with ≥2 point improvement in Subject Target Patch assessment at Week 24 compared to baseline is presented.
Time frame: Baseline - Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vehicle Topical Solution | Proportion of Subjects With ≥2 Point Improvement in Scalp Patient Reported Outcome for Target Patch at Week 24 | 6 Participants |
| ATI-50002 0.12% Topical Solution | Proportion of Subjects With ≥2 Point Improvement in Scalp Patient Reported Outcome for Target Patch at Week 24 | 8 Participants |
| ATI-50002 0.46% Topical Solution | Proportion of Subjects With ≥2 Point Improvement in Scalp Patient Reported Outcome for Target Patch at Week 24 | 9 Participants |
p-value: 0.33395% CI: [0.6, 5.4]Mixed Models Analysis
p-value: 0.38895% CI: [0.5, 5.2]Mixed Models Analysis
Secondary
Subject Global Impression of Change at Week 24
The Subject Global Impression of Change (SGIC) is a 7-point descriptive scale completed by subjects at Week 24. Scale response options ranged from 1. Very much improved to 7. Very much worse and are used to capture the subject's overall impression of change for his/her alopecia during the treatment period.
Time frame: Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vehicle Topical Solution | Subject Global Impression of Change at Week 24 | 2. Much improved | 2 Participants |
| Vehicle Topical Solution | Subject Global Impression of Change at Week 24 | 5. A little worse | 4 Participants |
| Vehicle Topical Solution | Subject Global Impression of Change at Week 24 | 4. No change | 3 Participants |
| Vehicle Topical Solution | Subject Global Impression of Change at Week 24 | 1. Very much improved | 4 Participants |
| Vehicle Topical Solution | Subject Global Impression of Change at Week 24 | 7. Very much worse | 1 Participants |
| Vehicle Topical Solution | Subject Global Impression of Change at Week 24 | 6. Much worse | 3 Participants |
| Vehicle Topical Solution | Subject Global Impression of Change at Week 24 | 3. A little improved | 8 Participants |
| ATI-50002 0.12% Topical Solution | Subject Global Impression of Change at Week 24 | 4. No change | 4 Participants |
| ATI-50002 0.12% Topical Solution | Subject Global Impression of Change at Week 24 | 1. Very much improved | 1 Participants |
| ATI-50002 0.12% Topical Solution | Subject Global Impression of Change at Week 24 | 2. Much improved | 4 Participants |
| ATI-50002 0.12% Topical Solution | Subject Global Impression of Change at Week 24 | 3. A little improved | 10 Participants |
| ATI-50002 0.12% Topical Solution | Subject Global Impression of Change at Week 24 | 5. A little worse | 4 Participants |
| ATI-50002 0.12% Topical Solution | Subject Global Impression of Change at Week 24 | 6. Much worse | 3 Participants |
| ATI-50002 0.12% Topical Solution | Subject Global Impression of Change at Week 24 | 7. Very much worse | 1 Participants |
| ATI-50002 0.46% Topical Solution | Subject Global Impression of Change at Week 24 | 5. A little worse | 6 Participants |
| ATI-50002 0.46% Topical Solution | Subject Global Impression of Change at Week 24 | 2. Much improved | 6 Participants |
| ATI-50002 0.46% Topical Solution | Subject Global Impression of Change at Week 24 | 7. Very much worse | 4 Participants |
| ATI-50002 0.46% Topical Solution | Subject Global Impression of Change at Week 24 | 6. Much worse | 1 Participants |
| ATI-50002 0.46% Topical Solution | Subject Global Impression of Change at Week 24 | 4. No change | 8 Participants |
| ATI-50002 0.46% Topical Solution | Subject Global Impression of Change at Week 24 | 3. A little improved | 5 Participants |
| ATI-50002 0.46% Topical Solution | Subject Global Impression of Change at Week 24 | 1. Very much improved | 3 Participants |
p-value: 0.481Wilcoxon (Mann-Whitney)
p-value: 0.357Wilcoxon (Mann-Whitney)
Secondary
Subject Global Impression of Treatment Satisfaction at Week 24
The Subject Global Impression of Treatment Satisfaction (SGITS) is a 7-point descriptive scale completed by subjects at Week 12 and Week 24. Scale response options ranged from 1. Extremely Satisfied to 7. Extremely Dissatisfied and are used to capture how satisfied or dissatisfied they are with the study medication treatment received for their alopecia areata.
Time frame: Week 24
Population: Intent-to-treat population using LOCF to address missing data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vehicle Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 2. Moderately satisfied | 6 Participants |
| Vehicle Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 5. A little dissatisfied | 3 Participants |
| Vehicle Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 4. Neither satisfied or dissatisfied | 5 Participants |
| Vehicle Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 1. Extremely satisfied | 5 Participants |
| Vehicle Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 7. Extremely dissatisfied | 9 Participants |
| Vehicle Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 6. Moderately dissatisfied | 5 Participants |
| Vehicle Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 3. A little satisfied | 5 Participants |
| ATI-50002 0.12% Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 4. Neither satisfied or dissatisfied | 8 Participants |
| ATI-50002 0.12% Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 1. Extremely satisfied | 8 Participants |
| ATI-50002 0.12% Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 2. Moderately satisfied | 5 Participants |
| ATI-50002 0.12% Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 3. A little satisfied | 7 Participants |
| ATI-50002 0.12% Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 5. A little dissatisfied | 4 Participants |
| ATI-50002 0.12% Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 6. Moderately dissatisfied | 3 Participants |
| ATI-50002 0.12% Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 7. Extremely dissatisfied | 6 Participants |
| ATI-50002 0.46% Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 5. A little dissatisfied | 2 Participants |
| ATI-50002 0.46% Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 2. Moderately satisfied | 7 Participants |
| ATI-50002 0.46% Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 7. Extremely dissatisfied | 7 Participants |
| ATI-50002 0.46% Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 6. Moderately dissatisfied | 4 Participants |
| ATI-50002 0.46% Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 4. Neither satisfied or dissatisfied | 6 Participants |
| ATI-50002 0.46% Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 3. A little satisfied | 3 Participants |
| ATI-50002 0.46% Topical Solution | Subject Global Impression of Treatment Satisfaction at Week 24 | 1. Extremely satisfied | 9 Participants |
p-value: 0.374Wilcoxon (Mann-Whitney)
p-value: 0.253Wilcoxon (Mann-Whitney)