Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers

NCT03071679 | Completed Phase 1

• 2 other identifiers: CLS001-CO-PR-0152016-004702-34
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (5)

• Local tolerability

  2 Weeks

• Safety (AE)

  2 Weeks

• Safety (Vital Signs)

  2 Weeks

• Safety (Laboratory Safety Testing)

  2 Weeks

• Safety (ECG)

  Within 3 Weeks

Study Arms (5)

Omiganan

EXPERIMENTAL

Drug: Omiganan

Imiquimod

EXPERIMENTAL

Drug: Imiquimod

Omiganan 1% and Imiquimod

EXPERIMENTAL

Drug: Omiganan 1% and Imiquimod

Omiganan 2.5% and Imiquimod

EXPERIMENTAL

Drug: Omiganan 2.5% and Imiquimod

Placebo

PLACEBO COMPARATOR

Vehicle

Drug: Placebo

Interventions

Omiganan DRUG

Omignan 1%, 2.5%

Omiganan

Imiquimod DRUG

Imiquimod 15mg

Imiquimod

Omiganan 1% and Imiquimod DRUG

Omiganan 1% and Imiquimod

Omiganan 1% and Imiquimod

Omiganan 2.5% and Imiquimod DRUG

Omiganan 2.5% and Imiquimod

Omiganan 2.5% and Imiquimod

Placebo DRUG

Vehicle

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maruho Co., Ltd.: lead

Study Sites (1)

LUMC/Centre for Human Drug Research

Leiden, Netherlands

Location

MeSH Terms

Interventions

Omiganan; Imiquimod

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• J. (Koos) Burggraaf, MD, PhD

  Centre for Human Drug Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 7, 2017
• Study Start: February 6, 2017
• Primary Completion: March 7, 2017
• Study Completion: March 7, 2017
• Last Updated: May 22, 2017

Record last verified: 2017-05

Locations

NL (1)