Clinical trial NCT03354637: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alopecia Areata
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-28
Enrollment: 129
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Percent Change From Baseline in the Severity of Alopecia Tool Score at Week 24
timeFrame: Baseline - Week 24
Secondary outcomes:
measure: Percent Change From Baseline in the Alopecia Density and Extent Score at Week 24
timeFrame: Baseline - Week 24
measure: Mean Change From Baseline in Severity of Alopecia Tool Score at Week 24
timeFrame: Baseline - Week 24
measure: Mean Change From Baseline in Alopecia Density and Extent Score at Week 24
timeFrame: Baseline - Week 24
measure: Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Severity of Alopecia Tool Scores at Week 24
timeFrame: Baseline - Week 24
measure: Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Alopecia Density and Extent Scores at Week 24
timeFrame: Baseline - Week 24
measure: Proportion of Subjects With ≥2 Point Improvement in Scalp Patient Reported Outcome for Target Patch at Week 24
timeFrame: Baseline - Week 24
measure: Proportion of Subjects With ≥1 Point Improvement in Scalp Patient Reported Outcome for Entire Scalp at Week 24
timeFrame: Baseline - Week 24
measure: Proportion of Subjects With ≥2-Point Improvement in Scalp Clinician Reported Outcome for Target Patch at Week 24
timeFrame: Baseline - Week 24
measure: Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24
timeFrame: Baseline - Week 24
measure: Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24
timeFrame: Baseline - Week 24
measure: Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24
timeFrame: Baseline - Week 24
measure: Alopecia Impact Assessment Patient Reported Outcome Change From Baseline at Week 24
timeFrame: Baseline - Week 24
measure: Subject Global Impression of Treatment Satisfaction at Week 24
timeFrame: Week 24
measure: Change in Dermatology Life Quality Index Total Score Between Baseline and Week 24
timeFrame: Baseline - Week 24
measure: Physician Global Impression of Change at Week 24
timeFrame: Week 24
measure: Subject Global Impression of Change at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Aclaris Investigator Site
state: California
city: Laguna Hills
country: United States
facility: Aclaris Investigator Site
state: California
city: Redwood City
country: United States
facility: Aclaris Investigator Site
state: California
city: Washington
country: United States
facility: Aclaris Investigator Site
state: District of Columbia
city: Boynton Beach
country: United States
facility: Aclaris Investigator Site
state: Florida
city: Miami
country: United States
facility: Aclaris Investigator Site
state: Florida
city: Boston
country: United States
facility: Aclaris Investigator Site
state: Massachusetts
city: Clinton Township
country: United States
facility: Aclaris Investigator Site
state: Michigan
city: Warren
country: United States
facility: Aclaris Investigator Site
state: Michigan
city: Fridley
country: United States
facility: Aclaris Investigator Site
state: Minnesota
city: Minneapolis
country: United States
facility: Aclaris Investigator Site
state: Minnesota
city: Omaha
country: United States
facility: Aclaris Investigator Site
state: Nebraska
city: New York
country: United States
facility: Aclaris Investigator Site
state: New York
city: Durham
country: United States
facility: Aclaris Investigator Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Aclaris Investigator Site
state: North Carolina
city: Portland
country: United States
facility: Aclaris Investigator Site
state: Oregon
city: Fort Washington
country: United States
facility: Aclaris Investigator Site
state: Pennsylvania
city: Knoxville
country: United States
facility: Aclaris Investigator Site
state: Tennessee
city: Nashville
country: United States
facility: Aclaris Investigator Site
state: Tennessee
city: Austin
country: United States
facility: Aclaris Investigator Site
state: Texas
city: Austin
country: United States
facility: Aclaris Investigator Site
state: Texas
city: San Antonio
country: United States
facility: Aclaris Investigator Site
state: Texas
city: San Antonio
country: United States
facility: Aclaris Investigator Site
state: Texas
Study officials:
References: