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CompletedNCT02945657Updated Nov 19, 2018Results posted

Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis

A Phase 2 interventional study of MM36 topical ointment, 1% in Atopic Dermatitis, sponsored by Medimetriks Pharmaceuticals, Inc. Completed at 12 sites in 3 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-11-19.

Sponsored by Medimetriks Pharmaceuticals, Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
2 Years to 17 Years
Sex
All
01

Study summary

The purpose of this study is to assess the pharmacokinetic parameters and safety of topical MM36 (OPA-15406) ointment in pediatric subjects with atopic dermatitis under maximal use conditions.

Read the detailed description

This is a multi-center, open-label study to assess the degree of systemic exposure and safety of MM36 1% ointment following 4 weeks of twice daily dosing under maximal-use conditions in pediatric subjects with atopic dermatitis.

02

Conditions studied

  • Atopic Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 32 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

This is the only study on the registry with Medimetriks Pharmaceuticals, Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects 2 to \<18 years of age
  • Diagnosis of atopic dermatitis (AD)
  • AD affecting ≥ 35% body surface area (BSA) if 2 to \< 12 years of age or ≥ 25% if subject is ≥ 12 years of age (excluding scalp and venous access areas)

Exclusion criteria

Exclusion Criteria:

  • Active or acute viral skin infection
  • History of recurrent bacterial infection
  • Malignancy
  • Clinically significant history or physical findings that may pose a health risk to subject or may have an impact on study assessments
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    MM36 1% ointment

    MM36 topical ointment, 1%, applied twice daily for 28 days

    Drug: MM36 topical ointment, 1%

Interventions

  • DrugMM36 topical ointment, 1%

    Twice daily application for 28 consecutive days

    Also known as: OPA-15406

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of MM36

    Maximum observed plasma concentration of MM36 on Day 1

    Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1

  2. Maximum Observed Plasma Concentration (Cmax) of MM36

    Maximum observed plasma concentration of MM36 after two weeks of twice daily application (steady state)

    Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15

  3. Time of Maximum Observed Plasma Concentration (Tmax) of MM36

    Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 1

    Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1

  4. Time of Maximum Observed Plasma Concentration (Tmax) of MM36

    Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 15

    Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15

  5. Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36

    Area Under the Plasma Concentration-time Curve from Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 1

    Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1

  6. Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36

    Area Under the Plasma Concentration-Time Curve From Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 15

    Time frame: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15

Secondary outcomes

  1. Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: up to 4 weeks

  2. Treatment-Emergent Adverse Events (AEs) According to Severity

    Number of Participants With Treatment-Emergent Adverse Events (AEs) According to Severity. Adverse events were classified according to severity as: mild - an event that is usually transient in nature and generally not interfering with normal activities; moderate - an event that is sufficiently discomforting to interfere with normal activities; severe - an event that is incapacitating with inability to work or do usual activity or inability to work or perform normal daily activity.

    Time frame: up to 4 weeks

  3. Application Site Adverse Events (AEs)

    Number of Participants With Application Site Adverse Events (AEs)

    Time frame: up to 4 weeks

  4. Application Site Adverse Events (AEs) According to Severity

    Number of Participants With Application Site Adverse Events (AEs) According to Severity. Adverse events were classified according to severity as: mild - an event that is usually transient in nature and generally not interfering with normal activities; moderate - an event that is sufficiently discomforting to interfere with normal activities; severe - an event that is incapacitating with inability to work or do usual activity or inability to work or perform normal daily activity.

    Time frame: up to 4 weeks

  5. Clinically Meaningful Laboratory Test Median Changes From Baseline

    Number of Participants With Clinically Meaningful Laboratory Test Median Changes From Baseline. Clinical meaningfulness of laboratory test changes was determined at the investigator's discretion.

    Time frame: Day 29

  6. Clinically Meaningful Vital Sign Median Changes From Baseline

    Number of Participants With Clinically Meaningful Vital Sign Median Changes From Baseline. Clinical meaningfulness of vital sign changes was determined at the investigator's discretion.

    Time frame: Day 29

  7. Clinically Meaningful ECG Median Changes From Baseline to Day 15

    Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion.

    Time frame: Day 15

  8. Clinically Meaningful ECG Median Changes From Baseline to Day 29

    Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion.

    Time frame: Day 29

07

Results

Posted Nov 19, 2018

Participant flow

Participant flow — Overall Study
MilestoneMM36 Topical Ointment, 1%
Started32
Completed28
Not completed4
Withdrew: Adverse event1
Withdrew: Withdrawal by parent/guardian3

Outcome measures

PrimaryMaximum Observed Plasma Concentration (Cmax) of MM36

Maximum observed plasma concentration of MM36 on Day 1

Time frame:
Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1
Reported as:
Mean · ng/mL
Maximum Observed Plasma Concentration (Cmax) of MM36
ng/mLMM36 Topical Ointment, 1%
Maximum Observed Plasma Concentration (Cmax) of MM3623.1 ± 23.4
PrimaryMaximum Observed Plasma Concentration (Cmax) of MM36

Maximum observed plasma concentration of MM36 after two weeks of twice daily application (steady state)

Time frame:
Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15
Reported as:
Mean · ng/mL
Maximum Observed Plasma Concentration (Cmax) of MM36
ng/mLMM36 Topical Ointment, 1%
Maximum Observed Plasma Concentration (Cmax) of MM3616.9 ± 21.9
PrimaryTime of Maximum Observed Plasma Concentration (Tmax) of MM36

Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 1

Time frame:
Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1
Reported as:
Mean · hours
Time of Maximum Observed Plasma Concentration (Tmax) of MM36
hoursMM36 Topical Ointment, 1%
Time of Maximum Observed Plasma Concentration (Tmax) of MM364.22 ± 2.02
PrimaryTime of Maximum Observed Plasma Concentration (Tmax) of MM36

Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 15

Time frame:
Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15
Reported as:
Mean · hours
Time of Maximum Observed Plasma Concentration (Tmax) of MM36
hoursMM36 Topical Ointment, 1%
Time of Maximum Observed Plasma Concentration (Tmax) of MM363.80 ± 2.24
PrimaryArea Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36

Area Under the Plasma Concentration-time Curve from Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 1

Time frame:
Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1
Reported as:
Mean · ng·hr/mL
Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36
ng·hr/mLMM36 Topical Ointment, 1%
Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36107 ± 94.1
PrimaryArea Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36

Area Under the Plasma Concentration-Time Curve From Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 15

Time frame:
Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15
Reported as:
Mean · ng·hr/mL
Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36
ng·hr/mLMM36 Topical Ointment, 1%
Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM3686.2 ± 79.6
SecondaryTreatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:
up to 4 weeks
Reported as:
Number · participants
Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
participantsMM36 Topical Ointment, 1%
No AE24
AE7
SAE0
SecondaryTreatment-Emergent Adverse Events (AEs) According to Severity

Number of Participants With Treatment-Emergent Adverse Events (AEs) According to Severity. Adverse events were classified according to severity as: mild - an event that is usually transient in nature and generally not interfering with normal activities; moderate - an event that is sufficiently discomforting to interfere with normal activities; severe - an event that is incapacitating with inability to work or do usual activity or inability to work or perform normal daily activity.

Time frame:
up to 4 weeks
Reported as:
Number · participants
Treatment-Emergent Adverse Events (AEs) According to Severity
participantsMM36 Topical Ointment, 1%
None24
Mild6
Moderate1
Severe0
SecondaryApplication Site Adverse Events (AEs)

Number of Participants With Application Site Adverse Events (AEs)

Time frame:
up to 4 weeks
Reported as:
Number · participants
Application Site Adverse Events (AEs)
participantsMM36 Topical Ointment, 1%
None29
Application site pain1
Application site rash1
SecondaryApplication Site Adverse Events (AEs) According to Severity

Number of Participants With Application Site Adverse Events (AEs) According to Severity. Adverse events were classified according to severity as: mild - an event that is usually transient in nature and generally not interfering with normal activities; moderate - an event that is sufficiently discomforting to interfere with normal activities; severe - an event that is incapacitating with inability to work or do usual activity or inability to work or perform normal daily activity.

Time frame:
up to 4 weeks
Reported as:
Number · participants
Application Site Adverse Events (AEs) According to Severity
participantsMM36 Topical Ointment, 1%
None29
Mild1
Moderate1
Severe0
SecondaryClinically Meaningful Laboratory Test Median Changes From Baseline

Number of Participants With Clinically Meaningful Laboratory Test Median Changes From Baseline. Clinical meaningfulness of laboratory test changes was determined at the investigator's discretion.

Time frame:
Day 29
Reported as:
Number · participants
Clinically Meaningful Laboratory Test Median Changes From Baseline
participantsMM36 Topical Ointment, 1%
Clinically Meaningful Laboratory Test Median Changes From Baseline0
SecondaryClinically Meaningful Vital Sign Median Changes From Baseline

Number of Participants With Clinically Meaningful Vital Sign Median Changes From Baseline. Clinical meaningfulness of vital sign changes was determined at the investigator's discretion.

Time frame:
Day 29
Reported as:
Number · participants
Clinically Meaningful Vital Sign Median Changes From Baseline
participantsMM36 Topical Ointment, 1%
Clinically Meaningful Vital Sign Median Changes From Baseline0
SecondaryClinically Meaningful ECG Median Changes From Baseline to Day 15

Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion.

Time frame:
Day 15
Reported as:
Number · participants
Clinically Meaningful ECG Median Changes From Baseline to Day 15
participantsMM36 Topical Ointment, 1%
Clinically Meaningful ECG Median Changes From Baseline to Day 150
SecondaryClinically Meaningful ECG Median Changes From Baseline to Day 29

Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion.

Time frame:
Day 29
Reported as:
Number · participants
Clinically Meaningful ECG Median Changes From Baseline to Day 29
participantsMM36 Topical Ointment, 1%
Clinically Meaningful ECG Median Changes From Baseline to Day 290

Adverse events

Collected over up to 4 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MM36 Topical Ointment, 1%0/31 (0%)0/31 (0%)7/31 (22.6%)
Most frequent other events
Most frequent other events
EventMM36 Topical Ointment, 1%
VomitingGastrointestinal disorders1/31
Application site painGeneral disorders1/31
Application site rashGeneral disorders1/31
Influenza like illnessGeneral disorders1/31
PyrexiaGeneral disorders1/31
NasopharyngitisInfections and infestations1/31
TonsillitisInfections and infestations1/31
Upper respiratory tract infectionInfections and infestations1/31
Eosinophil count increasedInvestigations1/31

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)MM36 Topical Ointment, 1%
<=18 years32
Between 18 and 65 years0
>=65 years0
Age, Continuous
Age, Continuous(years)MM36 Topical Ointment, 1%
Mean7.9 ± 4.33
Sex: Female, Male
Sex: Female, Male(Participants)MM36 Topical Ointment, 1%
Female16
Male16
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)MM36 Topical Ointment, 1%
Hispanic or Latino20
Not Hispanic or Latino12
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)MM36 Topical Ointment, 1%
American Indian or Alaska Native2
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American5
White17
More than one race7
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)MM36 Topical Ointment, 1%
United States15
Panama11
Honduras6
Percentage of Body Surface Area (BSA) Involved
Percentage of Body Surface Area (BSA) Involved(%)MM36 Topical Ointment, 1%
Mean43.7 ± 13.25
08

Study locations

12 sites
  • Medimetriks Investigational Site
    Fremont, California 94538, United States
  • Medimetriks Investigational Site
    Irvine, California 92697, United States
  • Medimetriks Investigational Site
    San Diego, California 92123, United States
  • Medimetriks Investigational Site
    Miami, Florida 33125, United States
  • Medimetriks Investigational Site
    Saint Joseph, Missouri 64506, United States
  • Medimetriks Investigational Site
    Portland, Oregon 97239, United States
  • Medimetriks Investigational Site
    Austin, Texas 78759, United States
  • Medimetriks Investigational Site
    Houston, Texas 77030, United States
  • Medimetriks Investigational Site
    Norfolk, Virginia 23502, United States
  • Medimetriks Investigational Site
    Spokane, Washington 99202, United States
  • Medimetriks Investigational Site
    San Pedro Sula, Honduras
  • Medimetriks Investigational Site
    Panama City, Panama
09

References and documents

Study documents

  • Statistical analysis plan · May 18, 2017
  • Study protocol · Jan 30, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02945657
Lead sponsor
Medimetriks Pharmaceuticals, Inc
Responsible party
Sponsor
First posted
Oct 26, 2016
Start date
Oct 2016
Primary completion
Jun 8, 2017
Completion
Jun 8, 2017
Results posted
Nov 19, 2018
Last update
Nov 19, 2018

Study contacts

Noah Rosenberg, MD
study director · Medimetriks Pharmaceuticals, Inc

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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