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

NCT02677636 | Withdrawn Phase 3

• 1 other identifier: M169981002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Atopic Dermatitis

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Visit 4 (Day 28)

Secondary Outcomes (1)

• 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)

Study Arms (2)

MSRD-100

EXPERIMENTAL

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

Placebo Comparator

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.

Drug: Vehicle

Interventions

MSRD-100 DRUG

MSRD-100 is a topical gel.

Also known as: Active

MSRD-100

Vehicle DRUG

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

Also known as: Placebo

Placebo Comparator

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are male or female, ≥3 months of age on the date of Baseline Visit.
• Subjects with a diagnosis of atopic dermatitis, active inflammation and meeting the Hanifin and Rajka Diagnosis Criteria for atopic dermatitis.
• Subjects must have an Investigator Global Assessment (IGA) score of ≥2 at baseline.
• 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).
• 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.

You may not qualify if:

• Unstable course of atopic dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to baseline.
• Concurrent conditions and history of other diseases.
• 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.
• Subjects who require treatment with any other topical or systemic therapy for the study disease other than bland emollients in untreated areas of disease.

Sponsors & Collaborators

• Merz North America, Inc.: lead

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Dermatitis; Pruritus; Genetic Diseases, Inborn; Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Skin Diseases, Eczematous; Skin Diseases, Genetic; Skin Diseases; Exanthema

Interventions

Exercise

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael Kuligowski, MD, PhD, MBA

  Study Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 9, 2016
• Primary Completion: July 1, 2016
• Last Updated: September 9, 2016

Record last verified: 2016-09