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

NCT ID: NCT02677636

Last Updated: 2016-09-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MSRD-100

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.

Group Type: EXPERIMENTAL

MSRD-100

Intervention Type: DRUG

MSRD-100 is a topical gel.

Placebo Comparator

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.

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Vehicle is a topical gel without the active ingredients in MSRD-100

Interventions

MSRD-100

MSRD-100 is a topical gel.

Intervention Type: DRUG

Vehicle

Vehicle is a topical gel without the active ingredients in MSRD-100

Intervention Type: DRUG

Other Intervention Names

Active; Placebo

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merz North America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Kuligowski, MD, PhD, MBA

Role: STUDY_DIRECTOR

Study Director

Other Identifiers

M169981002

Identifier Type: -

Identifier Source: org_study_id