NCT02677610

Efficacy and Safety Study of MSRD-100 in Subjects With Atopic Dermatitis >=3 Months of Age and Older

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of MSRD-100 in Subjects >=3 Months of Age With Atopic Dermatitis

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 3 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	MSRD-100	MSRD-100 is a topical gel.
DRUG	Vehicle	Vehicle is a topical gel without the active ingredient in MSRD-100

Timeline

• Primary completion: 2016-07-01
• Completion: 2017-03-01
• First posted: 2016-02-09
• Last updated: 2016-09-09