Back to resultsPharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Omiganan
Omiganan
Omiganan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects with mild to moderate AD (IGA 2 or 3) 18 to 65 years of age,inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AD following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
- Confirmed AD diagnosis;
- Symptoms present for at least 1 year;
- EASI between 7.1 - 50.0, inclusive at screening;
- 2-20% body surface area (BSA) affected at screening;
- Body mass index (BMI) between 18 and 35 kg/m2, inclusive, and with a minimum weight of 50 kg;
- Able to participate and willing to give written informed consent and to comply with the study restrictions;
- Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.
Exclusion Criteria:
- Any current and / or recurrent clinical significant skin condition other than AD;
- Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
- Ongoing use of prohibited atopic dermatitis treatments. Requires washout period prior to baseline (first dose of the study drug);
- Use of topical medication (prescription or over-the-counter [OTC]) within 14 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area;
- Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment;
- Known hypersensitivity to the compound or excipients of the compound or known hypersensitivity to one or more different emollients;
- Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
- Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
Sites / Locations
- LUMC/Centre for Human Drug Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Omiganan 1%
Omiganan 1.75%
Omiganan 2.5%
Vehicle
Arm Description
Outcomes
Primary Outcome Measures
Clinical Evaluation (oSCORAD)
oSCORAD Assessment
Clinical Evaluation (EASI)
EASI Assessment
Clinical Evaluation (IGA)
IGA Assessment
Patient-Orientated Outcome Measure (POEM)
Patient Assessment by collecting POEM
Dermatology Life Quality Index (DLQI)
Assessment of health-related quality of life by measuring DLQI
eDiary
Singe-Question assessment of pruritus and sleeplessness
Clinical Photography
Whole body photograph for qualitative and observational record
Pharmacodynamics (Biomarkers)
Local biomarkers sequencing
Pharmacodynamics (Microbiome)
Microbiome analysis
Pharmacodynamics (Microbiology)
Microbiology analysis
Pharmacodynamics (TEWL)
Transepidermal water-loss assessment
Pharmacodynamics (Thermography)
Skin temperature measurements will be taken
Pharmacodynamics (TAP)
Analysis of biomarkers captured by Transdermal Analysis Patch
Pharmacodynamics (Cytokines)
Cytokine assessment via blood evaluation
Secondary Outcome Measures
Safety (AE)
Adverse Events will be collected throughout the study
Safety (Vital Signs)
Vital Signs will be collected throughout the study
Safety (Clinical Laboratory Tests)
Lab samples collected in various timepoints within the study
Safety (ECG)
ECGs collected before beginning and end of study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03091426
Brief Title
Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacodynamics, Safety, Tolerability and Efficacy of Omiganan BID in Patients With Mild to Moderate Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maruho Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study has a randomized, double-blind, placebo-controlled design to assess the efficacy, pharmacodynamics and safety/tolerability of omiganan in patients with mild to moderate atopic dermatitis when applied BID to all atopic dermatitis lesions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omiganan 1%
Arm Type
Experimental
Arm Title
Omiganan 1.75%
Arm Type
Experimental
Arm Title
Omiganan 2.5%
Arm Type
Experimental
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Omiganan
Intervention Description
Omiganan 1%
Intervention Type
Drug
Intervention Name(s)
Omiganan
Intervention Description
Omiganan 1.75%
Intervention Type
Drug
Intervention Name(s)
Omiganan
Intervention Description
Omiganan 2.5%
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vehicle
Primary Outcome Measure Information:
Title
Clinical Evaluation (oSCORAD)
Description
oSCORAD Assessment
Time Frame
Within 7 Weeks
Title
Clinical Evaluation (EASI)
Description
EASI Assessment
Time Frame
Within 7 Weeks
Title
Clinical Evaluation (IGA)
Description
IGA Assessment
Time Frame
Within 7 Weeks
Title
Patient-Orientated Outcome Measure (POEM)
Description
Patient Assessment by collecting POEM
Time Frame
Within 7 Weeks
Title
Dermatology Life Quality Index (DLQI)
Description
Assessment of health-related quality of life by measuring DLQI
Time Frame
Within 7 Weeks
Title
eDiary
Description
Singe-Question assessment of pruritus and sleeplessness
Time Frame
Within 4 Weeks
Title
Clinical Photography
Description
Whole body photograph for qualitative and observational record
Time Frame
Within 7 Weeks
Title
Pharmacodynamics (Biomarkers)
Description
Local biomarkers sequencing
Time Frame
Within 7 Weeks
Title
Pharmacodynamics (Microbiome)
Description
Microbiome analysis
Time Frame
Within 7 Weeks
Title
Pharmacodynamics (Microbiology)
Description
Microbiology analysis
Time Frame
Within 7 Weeks
Title
Pharmacodynamics (TEWL)
Description
Transepidermal water-loss assessment
Time Frame
Within 7 Weeks
Title
Pharmacodynamics (Thermography)
Description
Skin temperature measurements will be taken
Time Frame
Within 7 Weeks
Title
Pharmacodynamics (TAP)
Description
Analysis of biomarkers captured by Transdermal Analysis Patch
Time Frame
Within 7 Weeks
Title
Pharmacodynamics (Cytokines)
Description
Cytokine assessment via blood evaluation
Time Frame
Within 7 Weeks
Secondary Outcome Measure Information:
Title
Safety (AE)
Description
Adverse Events will be collected throughout the study
Time Frame
Within 7 Weeks
Title
Safety (Vital Signs)
Description
Vital Signs will be collected throughout the study
Time Frame
Within 7 Weeks
Title
Safety (Clinical Laboratory Tests)
Description
Lab samples collected in various timepoints within the study
Time Frame
Within 7 Weeks
Title
Safety (ECG)
Description
ECGs collected before beginning and end of study
Time Frame
Within 7 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female subjects with mild to moderate AD (IGA 2 or 3) 18 to 65 years of age,inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AD following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
Confirmed AD diagnosis;
Symptoms present for at least 1 year;
EASI between 7.1 - 50.0, inclusive at screening;
2-20% body surface area (BSA) affected at screening;
Body mass index (BMI) between 18 and 35 kg/m2, inclusive, and with a minimum weight of 50 kg;
Able to participate and willing to give written informed consent and to comply with the study restrictions;
Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.
Exclusion Criteria:
Any current and / or recurrent clinical significant skin condition other than AD;
Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
Ongoing use of prohibited atopic dermatitis treatments. Requires washout period prior to baseline (first dose of the study drug);
Use of topical medication (prescription or over-the-counter [OTC]) within 14 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area;
Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment;
Known hypersensitivity to the compound or excipients of the compound or known hypersensitivity to one or more different emollients;
Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. (Koos) Burggraaf, MD, PhD
Organizational Affiliation
Centre for Human Drug Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
LUMC/Centre for Human Drug Research
City
Leiden
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis
We'll reach out to this number within 24 hrs