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

Primary Purpose

Atopic Dermatitis

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MSRD-100
Vehicle
Sponsored by
Merz North America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring 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

Eligibility Criteria

3 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    MSRD-100

    Vehicle

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Compare the proportion of subjects with an IGA score of 0 or 1 between the MSRD-100 and vehicle at Visit 4

    Full Information

    First Posted
    January 27, 2016
    Last Updated
    September 8, 2016
    Sponsor
    Merz North America, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02677610
    Brief Title
    Efficacy and Safety Study of MSRD-100 in Subjects With Atopic Dermatitis >=3 Months of Age and Older
    Acronym
    MSRD-100
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merz North America, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MSRD-100
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    MSRD-100
    Other Intervention Name(s)
    active
    Intervention Description
    MSRD-100 is a topical gel.
    Intervention Type
    Drug
    Intervention Name(s)
    Vehicle
    Other Intervention Name(s)
    placebo
    Intervention Description
    Vehicle is a topical gel without the active ingredient in MSRD-100
    Primary Outcome Measure Information:
    Title
    Compare the proportion of subjects with treatment success in the MSRD-100 and vehicle group
    Description
    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.
    Time Frame
    Visit 4 (Day 28)
    Secondary Outcome Measure Information:
    Title
    Compare the proportion of subjects with an IGA score of 0 or 1 between the MSRD-100 and vehicle at Visit 4
    Time Frame
    Visit 4 (Day 28)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key Inclusion Criteria: 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. Key Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Kuligowski, MD, PhD, MBA
    Organizational Affiliation
    Executive Medical Director
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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