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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