Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03354637
Recruitment Status : Terminated (The double-blind primary endpoint was not met. Open Label Extension period halted as a result.)
First Posted : November 28, 2017
Results First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

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


Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: ATI-50002 high dose Drug: ATI-50002 low dose Drug: Placebo Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 29, 2017
Actual Primary Completion Date : April 18, 2019
Actual Study Completion Date : September 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ATI-50002 high dose Topical Solution
High dose active
Drug: ATI-50002 high dose
Topical solution

Active Comparator: ATI-50002 low dose Topical Solution
low dose active
Drug: ATI-50002 low dose
Topical solution

Placebo Comparator: Vehicle Topical Solution
placebo
Drug: Placebo
Topical solution




Primary Outcome Measures :
  1. Percent Change From Baseline in the Severity of Alopecia Tool Score at Week 24 [ Time Frame: 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 Outcome Measures :
  1. Percent Change From Baseline in the Alopecia Density and Extent Score at Week 24 [ Time Frame: 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.

  2. Mean Change From Baseline in Severity of Alopecia Tool Score at Week 24 [ Time Frame: 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.

  3. Mean Change From Baseline in Alopecia Density and Extent Score at Week 24 [ Time Frame: 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.

  4. Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Severity of Alopecia Tool Scores at Week 24 [ Time Frame: 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.

  5. Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Alopecia Density and Extent Scores at Week 24 [ Time Frame: 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.

  6. Proportion of Subjects With ≥2 Point Improvement in Scalp Patient Reported Outcome for Target Patch at Week 24 [ Time Frame: 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.

  7. Proportion of Subjects With ≥1 Point Improvement in Scalp Patient Reported Outcome for Entire Scalp at Week 24 [ Time Frame: 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.

  8. Proportion of Subjects With ≥2-Point Improvement in Scalp Clinician Reported Outcome for Target Patch at Week 24 [ Time Frame: 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.

  9. Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 [ Time Frame: 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.

  10. Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 [ Time Frame: 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.

  11. Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 [ Time Frame: 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.

  12. Alopecia Impact Assessment Patient Reported Outcome Change From Baseline at Week 24 [ Time Frame: 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.

  13. Subject Global Impression of Treatment Satisfaction at Week 24 [ Time Frame: 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.

  14. Change in Dermatology Life Quality Index Total Score Between Baseline and Week 24 [ Time Frame: 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.

  15. Physician Global Impression of Change at Week 24 [ Time Frame: 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.

  16. Subject Global Impression of Change at Week 24 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354637


Locations
Layout table for location information
United States, California
Aclaris Investigator Site
Encinitas, California, United States, 92024
Aclaris Investigator Site
Laguna Hills, California, United States, 92653
Aclaris Investigator Site
Redwood City, California, United States, 94063
United States, District of Columbia
Aclaris Investigator Site
Washington, District of Columbia, United States, 20037
United States, Florida
Aclaris Investigator Site
Boynton Beach, Florida, United States, 33472
Aclaris Investigator Site
Miami, Florida, United States, 33136
United States, Massachusetts
Aclaris Investigator Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Aclaris Investigator Site
Clinton Township, Michigan, United States, 48038
Aclaris Investigator Site
Warren, Michigan, United States, 48088
United States, Minnesota
Aclaris Investigator Site
Fridley, Minnesota, United States, 55432
Aclaris Investigator Site
Minneapolis, Minnesota, United States, 55455
United States, Nebraska
Aclaris Investigator Site
Omaha, Nebraska, United States, 68144
United States, New York
Aclaris Investigator Site
New York, New York, United States, 10155
United States, North Carolina
Aclaris Investigator Site
Durham, North Carolina, United States, 27710
Aclaris Investigator Site
Winston-Salem, North Carolina, United States, 27104
United States, Oregon
Aclaris Investigator Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
Aclaris Investigator Site
Fort Washington, Pennsylvania, United States, 19034
United States, Tennessee
Aclaris Investigator Site
Knoxville, Tennessee, United States, 37922
Aclaris Investigator Site
Nashville, Tennessee, United States, 37215
United States, Texas
Aclaris Investigator Site
Austin, Texas, United States, 78745
Aclaris Investigator Site
Austin, Texas, United States, 78759
Aclaris Investigator Site
San Antonio, Texas, United States, 78229
Aclaris Investigator Site
San Antonio, Texas, United States, 78745
Sponsors and Collaborators
Aclaris Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Aclaris Therapeutics, Inc.:
Statistical Analysis Plan  [PDF] April 19, 2019
Study Protocol  [PDF] April 9, 2019

Layout table for additonal information
Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03354637    
Other Study ID Numbers: ATI-50002-AA-201
First Posted: November 28, 2017    Key Record Dates
Results First Posted: June 5, 2020
Last Update Posted: June 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical