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Completed

NCT Number: NCT02945657

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medimetriks Investigational Site, San Pedro Sula, Honduras

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

MM36 topical ointment, 1%

Drug

Twice daily application for 28 consecutive days

Other names: OPA-15406

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of MM36

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

    Maximum observed plasma concentration of MM36 on Day 1

  2. Maximum Observed Plasma Concentration (Cmax) of MM36

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Secondary outcomes

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

    Time frame: up to 4 weeks

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

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

    Time frame: up to 4 weeks

    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.

  3. Application Site Adverse Events (AEs)

    Time frame: up to 4 weeks

    Number of Participants With Application Site Adverse Events (AEs)

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

    Time frame: up to 4 weeks

    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.

  5. Clinically Meaningful Laboratory Test Median Changes From Baseline

    Time frame: Day 29

    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.

  6. Clinically Meaningful Vital Sign Median Changes From Baseline

    Time frame: Day 29

    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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medimetriks Pharmaceuticals, Inc

Industry

Registry information

Official study title

Protocol MEDI-MM36-206: A Phase 2 Multi-center, Open-label Study to Assess Pharmacokinetic Parameters and Safety of Topical MM36 (1%) in Pediatric Subjects 2 to < 18 Years of Age With Atopic Dermatitis Under Maximal Use Conditions

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 26, 2016
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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