This is a double-blind, randomized, vehicle-controlled, multi-center, parallel group Phase 3 study of MSRD-100 in the treatment of atopic dermatitis in subjects aged 3 months and up
This is a 4-week efficacy, safety and tolerability study of MSRD-100 applied twice daily for 4 weeks compared to its vehicle among subjects ≥3 months of age in the treatment of atopic dermatitis covering ≥5% body surface area. The study will consist of up to 4 visits which includes Screening - Visit 1 (Screening), Baseline - Visit 2 , Visit 3 (Day 14), and an End of Treatment/Final Study Visit - Visit 4 (Day 28). Study IDs M169981001 and M169981002 are two identical studies being run in parallel with different study sites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Compare the proportion of subjects with treatment success in the MSRD-100 and vehicle group
Treatment success is defined as an Investigator Global Assessment (IGA) score of clear or almost clear and a minimum of a 2-grade improvement in IGA score from baseline plus no worsening on any of the signs present at baseline. The primary endpoint is a composite of: (1) the IGA score of clear or almost clear as well as subjects having a minimum two point improvement on the IGA, plus (2) no worsening of any of the signs present at baseline.
Time frame: Visit 4 (Day 28)
Compare the proportion of subjects with an IGA score of 0 or 1 between the MSRD-100 and vehicle at Visit 4
Time frame: Visit 4 (Day 28)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.