search
Back to results

A Study of ATI-50002 Topical Solution for the Treatment of Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ATI-50002 high dose
ATI-50002 low dose
Placebo
Sponsored by
Aclaris Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site
  • Aclaris Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

ATI-50002 high dose Topical Solution

ATI-50002 low dose Topical Solution

Vehicle Topical Solution

Arm Description

High dose active

low dose active

placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 16, 2017
Last Updated
May 20, 2020
Sponsor
Aclaris Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03354637
Brief Title
A Study of ATI-50002 Topical Solution for the Treatment of Alopecia Areata
Official Title
A Randomized, Double-Blind, Vehicle-Controlled Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ATI-50002 Topical Solution Administered Twice-Daily for 6 Months in Adolescents and Adult Subjects With Stable Patchy Alopecia Areata With Optional Long-Term Open-Label Extension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
The double-blind primary endpoint was not met. Open Label Extension period halted as a result.
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
April 18, 2019 (Actual)
Study Completion Date
September 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aclaris Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATI-50002 high dose Topical Solution
Arm Type
Active Comparator
Arm Description
High dose active
Arm Title
ATI-50002 low dose Topical Solution
Arm Type
Active Comparator
Arm Description
low dose active
Arm Title
Vehicle Topical Solution
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
ATI-50002 high dose
Intervention Description
Topical solution
Intervention Type
Drug
Intervention Name(s)
ATI-50002 low dose
Intervention Description
Topical solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Topical solution
Primary Outcome Measure Information:
Title
Percent Change From Baseline in the Severity of Alopecia Tool Score at Week 24
Description
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
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in the Alopecia Density and Extent Score at Week 24
Description
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
Title
Mean Change From Baseline in Severity of Alopecia Tool Score at Week 24
Description
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
Title
Mean Change From Baseline in Alopecia Density and Extent Score at Week 24
Description
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
Title
Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Severity of Alopecia Tool Scores at Week 24
Description
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
Title
Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Alopecia Density and Extent Scores at Week 24
Description
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
Title
Proportion of Subjects With ≥2 Point Improvement in Scalp Patient Reported Outcome for Target Patch at Week 24
Description
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
Title
Proportion of Subjects With ≥1 Point Improvement in Scalp Patient Reported Outcome for Entire Scalp at Week 24
Description
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
Title
Proportion of Subjects With ≥2-Point Improvement in Scalp Clinician Reported Outcome for Target Patch at Week 24
Description
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
Title
Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24
Description
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
Title
Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24
Description
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
Title
Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24
Description
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
Title
Alopecia Impact Assessment Patient Reported Outcome Change From Baseline at Week 24
Description
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
Title
Subject Global Impression of Treatment Satisfaction at Week 24
Description
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
Title
Change in Dermatology Life Quality Index Total Score Between Baseline and Week 24
Description
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
Title
Physician Global Impression of Change at Week 24
Description
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
Title
Subject Global Impression of Change at Week 24
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a clinical diagnosis of stable patchy alopecia areata (AA) defined as no current areas of spontaneous regrowth. 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. Have a duration of the current episode of scalp hair loss of a minimum of 6 months and a maximum of 12 years. 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: 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. Diffuse alopecia areata. Concomitant hair loss disorder (by history or physical exam) such as androgenetic alopecia or scarring alopecia (e.g., cicatricial alopecia, frontal fibrosing alopecia, etc.). 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 AA 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.
Facility Information:
Facility Name
Aclaris Investigator Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Aclaris Investigator Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Aclaris Investigator Site
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Aclaris Investigator Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Aclaris Investigator Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Aclaris Investigator Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Aclaris Investigator Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Aclaris Investigator Site
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Aclaris Investigator Site
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Aclaris Investigator Site
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Aclaris Investigator Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Aclaris Investigator Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Aclaris Investigator Site
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
Aclaris Investigator Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Aclaris Investigator Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Aclaris Investigator Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Aclaris Investigator Site
City
Fort Washington
State/Province
Pennsylvania
ZIP/Postal Code
19034
Country
United States
Facility Name
Aclaris Investigator Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Aclaris Investigator Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Aclaris Investigator Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Aclaris Investigator Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Aclaris Investigator Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Aclaris Investigator Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78745
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Study of ATI-50002 Topical Solution for the Treatment of Alopecia Areata

We'll reach out to this number within 24 hrs