Atopic Dermatitis
Conditions
Keywords
Dermatitis, Atopic, Eczema, Dermatitis, Pruritus, Genetic Diseases, Inborn, Hypersensitivity, Hypersensitivity, Immediate, Immune System Diseases, Skin Diseases, Eczematous, Skin Diseases, Genetic, Skin Diseases, Itching, Rash, Steroid
Brief 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.
Interventions
DRUGMSRD-100
MSRD-100 is a topical gel.
DRUGVehicle
Vehicle is a topical gel without the active ingredients in MSRD-100
Sponsors
Merz North America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the proportion of subjects with treatment success in the MSRD-100 and vehicle group | Visit 4 (Day 28) | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Compare the proportion of subjects with an IGA score of 0 or 1 between the MSRD-100 and vehicle at Visit 4 | Visit 4 (Day 28) |
Outcome results
None listed