Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: MM36 topical ointment, 1%
- Registration Number
- NCT02945657
- Lead Sponsor
- Medimetriks Pharmaceuticals, Inc
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MM36 1% ointment MM36 topical ointment, 1% MM36 topical ointment, 1%, applied twice daily for 28 days
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of MM36 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)
Time of Maximum Observed Plasma Concentration (Tmax) of MM36 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
Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36 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 Outcome Measures
Name Time Method Application Site Adverse Events (AEs) up to 4 weeks Number of Participants With Application Site Adverse Events (AEs)
Clinically Meaningful ECG Median Changes From Baseline to Day 29 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.
Clinically Meaningful Vital Sign Median Changes From Baseline 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.
Clinically Meaningful Laboratory Test Median Changes From Baseline 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.
Clinically Meaningful ECG Median Changes From Baseline to Day 15 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.
Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 4 weeks Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-Emergent Adverse Events (AEs) According to Severity 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.
Application Site Adverse Events (AEs) According to Severity 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.
Trial Locations
- Locations (1)
Medimetriks Investigational Site
🇵🇦Panama City, Panama