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CompletedNCT03071679Updated May 22, 2017

Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers

A Phase 1 interventional study of Omiganan and Imiquimod in Healthy, sponsored by Maruho Co., Ltd.. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-22.

Sponsored by Maruho Co., Ltd. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Maruho Co., Ltd. is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Omiganan

    Drug: Omiganan

  • Experimental
    Imiquimod

    Drug: Imiquimod

  • Experimental
    Omiganan 1% and Imiquimod

    Drug: Omiganan 1% and Imiquimod

  • Experimental
    Omiganan 2.5% and Imiquimod

    Drug: Omiganan 2.5% and Imiquimod

  • Placebo comparator
    Placebo

    Vehicle

    Drug: Placebo

Interventions

  • DrugOmiganan

    Omignan 1%, 2.5%

  • DrugImiquimod

    Imiquimod 15mg

  • DrugOmiganan 1% and Imiquimod

    Omiganan 1% and Imiquimod

  • DrugOmiganan 2.5% and Imiquimod

    Omiganan 2.5% and Imiquimod

  • DrugPlacebo

    Vehicle

06

What researchers measure

Primary outcomes

  1. Clinical Evaluation

    Erythema grading scale

    Time frame: 6 Days

  2. Pharmacodynamic (Biomarkers)

    Local biomarker sequencing

    Time frame: Within 2 Weeks

  3. Pharmacodynamic (Histology)

    Histological parameters assessment

    Time frame: Within 2 Weeks

  4. Pharmacodynamic (Immunohistochemistry)

    Identification of lymphocytes and lineage cells

    Time frame: Within 2 Weeks

  5. Pharmacodynamic (TAP)

    Qualitatively and Quantitatively analyze biomarkers captured by Trans Epidermal Patch (TAP)

    Time frame: Within 6 Days

  6. pharmacodynamic (LSCI)

    Assess cutaneous microcirculation using laster speckle imager

    Time frame: Within 6 Days

  7. Pharmacodynamic (Colorimetry)

    Colorimetric assessment by erythema grading scale

    Time frame: Within 6 Days

  8. Pharmacodynamic (Photography)

    Photographs of treatment sites will be taken

    Time frame: Within 2 Weeks

  9. Pharmacodynamic (Thermography)

    Skin temperature measurements will be taken

    Time frame: Within 2 Weeks

Secondary outcomes

  1. Local tolerability

    Visual Analogue Scale (NRS) pruritus and pain

    Time frame: 2 Weeks

  2. Safety (AE)

    Adverse Events will be collected throughout the study

    Time frame: 2 Weeks

  3. Safety (Vital Signs)

    Vital Signs will be collected throughout the study

    Time frame: 2 Weeks

  4. Safety (Laboratory Safety Testing)

    Lab samples collected in various timepoints within the study

    Time frame: 2 Weeks

  5. Safety (ECG)

    ECGs will be collected before beginning and end of study

    Time frame: Within 3 Weeks

07

Study locations

1 site
  • LUMC/Centre for Human Drug Research
    Leiden, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03071679
Lead sponsor
Maruho Co., Ltd.
Responsible party
Sponsor
First posted
Mar 7, 2017
Start date
Feb 6, 2017
Primary completion
Mar 7, 2017
Completion
Mar 7, 2017
Last update
May 22, 2017

Study contacts

J. (Koos) Burggraaf, MD, PhD
principal investigator · Centre for Human Drug Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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