Atopic DermatitisPhase 3MSRD-100NCT02677610
Efficacy and Safety Study of MSRD-100 in Subjects With Atopic Dermatitis >=3 Months of Age and Older
A Phase 3 study testing MSRD-100 in people with Atopic Dermatitis, run by Merz North America, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- MSRD-100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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
- Being tested
- MSRD-100, Vehicle
- 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
- Medical subject headings
- Dermatitis, Atopic, Eczema, Dermatitis, Pruritus, Genetic Diseases, Inborn, Hypersensitivity, Hypersensitivity, Immediate, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSRD-100Drug
Also called active
MSRD-100 is a topical gel.
VehicleDrug
Also called placebo
Vehicle is a topical gel without the active ingredient in MSRD-100
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: MSRD-100 |
| Vehicle | 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. Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Visit 4 (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Primary completionJul 2016
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Kuligowski, MD, PhD, MBA, Study director, Executive Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677610
- Sponsor's protocol ID
- M169981001
- Acronym
- MSRD-100
- Status last verified
- Sep 2016
- First submitted
- 27 Jan 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02677610
- Acronym / sponsor ID
- MSRD-100 / M169981001
- Conditions
- Atopic Dermatitis
- Keywords
- Dermatitis, Atopic, Eczema, Dermatitis, Pruritus, Genetic Diseases, Inborn, Hypersensitivity, Hypersensitivity, Immediate, Immune System Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Mar 2017 (estimated)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSRD-100 | Experimental | Drug: MSRD-100MSRD-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. |
| Vehicle | Placebo comparator | Drug: VehicleThe 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. |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSRD-100Also: activeMSRD-100 is a topical gel. | Drug | MSRD-100 |
| VehicleAlso: placeboVehicle is a topical gel without the active ingredient in MSRD-100 | Drug | Vehicle |
Primary outcome
Compare the proportion of subjects with treatment success in the MSRD-100 and vehicle group
Time frame: 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.
1 secondary outcome
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kuligowski, MD, PhD, MBA study director
Executive Medical Director
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MSRD-100 in people with Atopic Dermatitis, run by Merz North America, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the proportion of subjects with treatment success in the MSRD-100 and vehicle group (time frame: Visit 4 (Day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.