Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers

A Randomized, Evaluator-blinded, Vehicle-controlled Study to Explore the Pharmacodynamic Effects of Omiganan and Omiganan in Combination With Imiquimod in Healthy Volunteers

This study has a randomized, evaluator-blinded, vehicle- controlled study to assess the pharmacodynamics of omiganan and omiganan with imiquimod in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Omiganan; Drug: Imiquimod; Drug: Omiganan 1% and Imiquimod; Drug: Omiganan 2.5% and Imiquimod

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Leiden, Netherlands
    • LUMC/Centre for Human Drug Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and female subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, blood serology and urinalysis.
• Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg.
• Fitzpatrick skin type I-III (Caucasian)
• 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.
• Able and willing to give written informed consent and to comply with the study restrictions.

Exclusion Criteria:

• Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients
• Family history of psoriasis
• History of pathological scar formation (keloid, hypertrophic scar)
• Have any current and / or recurrent pathologically, clinical significant skin condition.
• Previous use of imiquimod/ resiquimod/ gardiquimod
• Known hypersensitivity to the (non)investigational drug, drugs of the same class, or any of their excipients.
• Hypersensitivity for dermatological marker at screening
• Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study.
• Use of topical medication (prescription or over-the-counter [OTC]) within 30 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.
• 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
• Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imiquimod	Drug: Imiquimod; Imiquimod 15mg
Experimental: Omiganan	Drug: Omiganan; Omignan 1%, 2.5%
Experimental: Omiganan 1% and Imiquimod	Drug: Omiganan 1% and Imiquimod; Omiganan 1% and Imiquimod
Experimental: Omiganan 2.5% and Imiquimod	Drug: Omiganan 2.5% and Imiquimod; Omiganan 2.5% and Imiquimod
Placebo Comparator: Placebo; Vehicle	Drug: Placebo; Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Evaluation	Erythema grading scale	6 Days
Pharmacodynamic (Biomarkers)	Local biomarker sequencing	Within 2 Weeks
Pharmacodynamic (Histology)	Histological parameters assessment	Within 2 Weeks
Pharmacodynamic (Immunohistochemistry)	Identification of lymphocytes and lineage cells	Within 2 Weeks
Pharmacodynamic (TAP)	Qualitatively and Quantitatively analyze biomarkers captured by Trans Epidermal Patch (TAP)	Within 6 Days
pharmacodynamic (LSCI)	Assess cutaneous microcirculation using laster speckle imager	Within 6 Days
Pharmacodynamic (Colorimetry)	Colorimetric assessment by erythema grading scale	Within 6 Days
Pharmacodynamic (Photography)	Photographs of treatment sites will be taken	Within 2 Weeks
Pharmacodynamic (Thermography)	Skin temperature measurements will be taken	Within 2 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local tolerability	Visual Analogue Scale (NRS) pruritus and pain	2 Weeks
Safety (AE)	Adverse Events will be collected throughout the study	2 Weeks
Safety (Vital Signs)	Vital Signs will be collected throughout the study	2 Weeks
Safety (Laboratory Safety Testing)	Lab samples collected in various timepoints within the study	2 Weeks
Safety (ECG)	ECGs will be collected before beginning and end of study	Within 3 Weeks

Collaborators and Investigators

• Sponsor: Maruho Co., Ltd.
• Investigators: Principal Investigator: J. (Koos) Burggraaf, MD, PhD, Centre For Human Drug Research

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): March 7, 2017
• Study Completion (Actual): March 7, 2017

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): May 22, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferon Inducers; Imiquimod; Antimicrobial Cationic Peptides
• Other Study ID Numbers: CLS001-CO-PR-015; 2016-004702-34 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No