This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis
This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis. Approximately 210 subjects will be randomly assigned to receive ATx201 OINTMENT 4%, ATx201 OINTMENT 7%, or OINTMENT vehicle for 6 weeks. Treatments will be balanced into consecutive blocks in 1:1:1 ratio for the active groups and vehicle. Sixteen additional subjects (adults and adolescents) will be enrolled in a 2-week open label substudy of twice-daily ATx201 OINTMENT 7% to evaluate the PK profile of ATx201.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
Topical
ATx201 OINTMENT vehicle
UNION therapeutics Investigational Site 5
Pleven, Bulgaria
UNION therapeutics Investigational Site 2
Sofia, Bulgaria
UNION therapeutics Investigational Site 3
Sofia, Bulgaria
UNION therapeutics Investigational Site 4
Mean change from baseline at Week 6 in Eczema Area Severity Index (EASI)
EASI mean change from baseline at Week 6
Time frame: Baseline to Week 6
Investigator Global Assessment (IGA) success
IGA success with defined improvement from baseline; success defined as clear (0) or almost clear (1) with ≥2 grade improvement from baseline
Time frame: Baseline to Week 6
change from baseline in Investigator Global Assessment (IGA) scoring
Distribution of IGA scores and change from baseline
Time frame: Baseline to Week 6
Mean change from baseline in Target lesion Total Sign Score (TSS)
Target lesion TSS mean change from baseline
Time frame: Baseline to Week 6
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