A Phase 3 interventional study of MSRD-100 and Vehicle in Atopic Dermatitis, sponsored by Merz North America, Inc.. Withdrawn. Open to participants aged 3 Months and older. Per ClinicalTrials.gov, last updated 2016-09-09.
Sponsored by Merz North America, Inc. · Phase 3, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
Browse Dermatitis, Atopic studies →Merz North America, Inc. is the lead sponsor of 52 studies on the registry; 2 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 18 (95%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
MSRD-100 is a topical gel with an active ingredient in a vehicle. Excipients are purified water, propylene glycol, polysorbate 20, benzyl alcohol, edetate disodium, diethylene glycol monoethyl ether and hydroxyethyl cellulose. Application is twice daily for 28 days.
Drug: MSRD-100
The vehicle is a topical gel and contains excipients of the formulation: purified water, propylene glycol, polysorbate 20, benzyl alcohol, edetate disodium, diethylene glycol monoethyl ether and hydroxyethyl cellulose. It does not contain the active ingredient MSRD-100. Application is twice daily for 28 days.
Drug: Vehicle
MSRD-100 is a topical gel.
Also known as: active
Vehicle is a topical gel without the active ingredient in MSRD-100
Also known as: placebo
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)
No study locations are listed for this record.
This study is withdrawn, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Merz North America, Inc.