This is a first-in-human, randomized, double-blind, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, tolerability, and PK of ATI-1777 solution following twice-daily applications to target areas of participants with moderate or severe atopic dermatitis (AD).
Participants underwent screening evaluations to determine eligibility up to 30 days prior to randomization. Participants who meet all the entry criteria were randomized on Day 1 to active or vehicle treatment. Participants applied study drug (ATI-1777 topical solution 2.0% w/w or vehicle) twice daily for 4 weeks with weekly study visits and were to return 2 weeks after the last dose of study medication for a Post treatment Follow-up (PTFU) Visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Aclaris Investigational Site
Scottsdale, Arizona, United States
Aclaris Investigational Site
Encino, California, United States
Aclaris Investigational Site
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4
The EASI evaluation was performed by the Principal Investigator and evaluated atopic dermatitis in each of 3 body regions (trunk \[excluding groin and genitalia\], upper extremities \[excluding palms of hands\], and lower extremities \[excluding soles of feet\]). The EASI scoring system uses a defined process to grade the severity of the signs of atopic dermatitis and the extent affected. EASI Scores ranged from 0-72, with higher scores indicative of more severe disease.
Time frame: Baseline, Week 4
Percent Change From Baseline in EASI Score at Days 8 and 15
The EASI evaluation is performed by the Principal Investigator and will evaluate atopic dermatitis in each of 3 body regions (trunk \[excluding groin and genitalia\], upper extremities \[excluding palms of hands\], and lower extremities \[excluding soles of feet\]). The EASI scoring system uses a defined process to grade the severity of the signs of atopic dermatitis and the extent affected. EASI Scores range from 0-72, with higher scores indicative of more severe disease.
Time frame: Baseline, Days 8 and 15
Number of Participants Who Achieve 50% Improvement in EASI Score (EASI 50) by Week 4
The EASI evaluation is performed by the Principal Investigator and will evaluate atopic dermatitis in each of 3 body regions (trunk \[excluding groin and genitalia\], upper extremities \[excluding palms of hands\], and lower extremities \[excluding soles of feet\]). The EASI scoring system uses a defined process to grade the severity of the signs of atopic dermatitis and the extent affected. EASI Scores range from 0-72, with higher scores indicative of more severe disease.
Time frame: Week 4
Number of Participants Who Achieve 75% Improvement in EASI Score (EASI-75) by Week 4
The EASI evaluation is performed by the Principal Investigator and will evaluate atopic dermatitis in each of 3 body regions (trunk \[excluding groin and genitalia\], upper extremities \[excluding palms of hands\], and lower extremities \[excluding soles of feet\]). The EASI scoring system uses a defined process to grade the severity of the signs of atopic dermatitis and the extent affected. EASI Scores range from 0-72, with higher scores indicative of more severe disease.
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Los Angeles, California, United States
Aclaris Investigational Site
Tampa, Florida, United States
Aclaris Investigational Site
Indianapolis, Indiana, United States
Aclaris Investigational Site
Overland Park, Kansas, United States
Aclaris Investigational Site
Omaha, Nebraska, United States
Aclaris Investigational Site
Kew Gardens, New York, United States
Aclaris Investigational Site
Newtown Square, Pennsylvania, United States
Aclaris Investigational Site
Fountain Inn, South Carolina, United States
...and 4 more locations
Time frame: Week 4
Number of Participants Who Achieve 90% Improvement in EASI Score (EASI-90) by Week 4
The EASI evaluation is performed by the Principal Investigator and will evaluate atopic dermatitis in each of 3 body regions (trunk \[excluding groin and genitalia\], upper extremities \[excluding palms of hands\], and lower extremities \[excluding soles of feet\]). The EASI scoring system uses a defined process to grade the severity of the signs of atopic dermatitis and the extent affected. EASI Scores range from 0-72, with higher scores indicative of more severe disease.
Time frame: Week 4
Change From Baseline in Investigator Global Assessment (IGA) Score for Atopic Dermatitis at Days 8 and 15, and Week 4
The IGA is a validated investigator's assessment of the average overall severity of participants' atopic dermatitis at a particular point in time. Scores ranged from 0-4, with higher scores indicative of more severe disease.
Time frame: Baseline, Days 8 and 15, and Week 4
Change From Baseline in Percent of Body Surface Area (BSA) of Atopic Dermatitis at Days 8 and 15 and Week 4
The total percentage of the participants BSA affected by atopic dermatitis was estimated by the investigator or designee using the handprint method, which estimates that the area of a participants' full handprint (fingers and thumbs together) constitutes 1% of their total BSA. Scores ranged from 0-100%, with higher scores indicative of increased percentage of atopic dermatitis on the skin.
Time frame: Baseline, Days 8 and 15, and Week 4
Change From Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) Score at Days 8 and 15, and Week 4
The PP-NRS is a single patient-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours. Scores ranged from 0-10, with higher scores indicative of more severe itching.
Time frame: Baseline, Days 8 and 15, and Week 4