Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: Omiganan; Drug: Imiquimod; Drug: Omiganan 1% and Imiquimod; Drug: Omiganan 2.5% and Imiquimod

• Registration Number: NCT03071679
• Lead Sponsor: Maruho Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-06
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-03-01
• Primary Completion: 2017-03-07
• Study Completion: 2017-03-07
• Study First Posted: 2017-03-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Vehicle
Omiganan	Omiganan	-
Imiquimod	Imiquimod	-
Omiganan 1% and Imiquimod	Omiganan 1% and Imiquimod	-
Omiganan 2.5% and Imiquimod	Omiganan 2.5% and Imiquimod	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

LUMC/Centre for Human Drug Research; 🇳🇱 Leiden, Netherlands