Overview

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

Status:
Withdrawn
Trial end date:
2017-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merz North America, Inc.
Merz Pharmaceuticals, LLC
Criteria
Key Inclusion Criteria:

1. Subjects who are male or female, ≥3 months of age on the date of Baseline Visit.

2. Subjects with a diagnosis of atopic dermatitis, active inflammation and meeting the
Hanifin and Rajka Diagnosis Criteria for Atopic Dermatitis.

3. Subjects must have an Investigator Global Assessment (IGA) score of ≥2 at baseline.

4. Subjects who have atopic dermatitis covering ≥5% Body Surface Area (BSA) excluding the
eyelids, perioral area, around the nostrils, and in the diaper area (for subjects who
wear diapers or plastic pants).

5. Subjects who have atopic dermatitis with a sign and symptom score ≥ 2 on the following
three signs and symptoms: erythema, infiltration/papulation, and
erosion/oozing/crusting present in at least one body surface area affected.

Key Exclusion Criteria:

1. Unstable course of Atopic Dermatitis (spontaneously improving or rapidly
deteriorating) as determined by the investigator over the previous 4 weeks prior to
baseline.

2. Concurrent conditions and history of other diseases.

3. Used any of the following treatments within the indicated washout period before the
baseline visit or those who would require the following during the study.

4. Subjects who require treatment with any other topical or systemic therapy for the
study disease other than bland emollients in untreated areas of disease.