Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis
Overview
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.
Full Title of Study: “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
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: December 20, 2017
Interventions
- Drug: Omiganan
- Omiganan 1%
- Drug: Omiganan
- Omiganan 1.75%
- Drug: Omiganan
- Omiganan 2.5%
- Drug: Placebo
- Vehicle
Arms, Groups and Cohorts
- Experimental: Omiganan 1%
- Experimental: Omiganan 1.75%
- Experimental: Omiganan 2.5%
- Placebo Comparator: Vehicle
Clinical Trial Outcome Measures
Primary Measures
- Clinical Evaluation (oSCORAD)
- Time Frame: Within 7 Weeks
- oSCORAD Assessment
- Clinical Evaluation (EASI)
- Time Frame: Within 7 Weeks
- EASI Assessment
- Clinical Evaluation (IGA)
- Time Frame: Within 7 Weeks
- IGA Assessment
- Patient-Orientated Outcome Measure (POEM)
- Time Frame: Within 7 Weeks
- Patient Assessment by collecting POEM
- Dermatology Life Quality Index (DLQI)
- Time Frame: Within 7 Weeks
- Assessment of health-related quality of life by measuring DLQI
- eDiary
- Time Frame: Within 4 Weeks
- Singe-Question assessment of pruritus and sleeplessness
- Clinical Photography
- Time Frame: Within 7 Weeks
- Whole body photograph for qualitative and observational record
- Pharmacodynamics (Biomarkers)
- Time Frame: Within 7 Weeks
- Local biomarkers sequencing
- Pharmacodynamics (Microbiome)
- Time Frame: Within 7 Weeks
- Microbiome analysis
- Pharmacodynamics (Microbiology)
- Time Frame: Within 7 Weeks
- Microbiology analysis
- Pharmacodynamics (TEWL)
- Time Frame: Within 7 Weeks
- Transepidermal water-loss assessment
- Pharmacodynamics (Thermography)
- Time Frame: Within 7 Weeks
- Skin temperature measurements will be taken
- Pharmacodynamics (TAP)
- Time Frame: Within 7 Weeks
- Analysis of biomarkers captured by Transdermal Analysis Patch
- Pharmacodynamics (Cytokines)
- Time Frame: Within 7 Weeks
- Cytokine assessment via blood evaluation
Secondary Measures
- Safety (AE)
- Time Frame: Within 7 Weeks
- Adverse Events will be collected throughout the study
- Safety (Vital Signs)
- Time Frame: Within 7 Weeks
- Vital Signs will be collected throughout the study
- Safety (Clinical Laboratory Tests)
- Time Frame: Within 7 Weeks
- Lab samples collected in various timepoints within the study
- Safety (ECG)
- Time Frame: Within 7 Weeks
- ECGs collected before beginning and end of study
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Maruho Co., Ltd.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- J. (Koos) Burggraaf, MD, PhD, Principal Investigator, Centre for Human Drug Research
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