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
This study has a randomized, evaluator-blinded, vehicle- controlled study to assess the pharmacodynamics of omiganan and omiganan with imiquimod in healthy volunteers.
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.
Exclusion Criteria:
Drug: Omiganan
Drug: Imiquimod
Drug: Omiganan 1% and Imiquimod
Drug: Omiganan 2.5% and Imiquimod
Vehicle
Drug: Placebo
Omignan 1%, 2.5%
Imiquimod 15mg
Omiganan 1% and Imiquimod
Omiganan 2.5% and Imiquimod
Vehicle
Clinical Evaluation
Erythema grading scale
Time frame: 6 Days
Pharmacodynamic (Biomarkers)
Local biomarker sequencing
Time frame: Within 2 Weeks
Pharmacodynamic (Histology)
Histological parameters assessment
Time frame: Within 2 Weeks
Pharmacodynamic (Immunohistochemistry)
Identification of lymphocytes and lineage cells
Time frame: Within 2 Weeks
Pharmacodynamic (TAP)
Qualitatively and Quantitatively analyze biomarkers captured by Trans Epidermal Patch (TAP)
Time frame: Within 6 Days
pharmacodynamic (LSCI)
Assess cutaneous microcirculation using laster speckle imager
Time frame: Within 6 Days
Pharmacodynamic (Colorimetry)
Colorimetric assessment by erythema grading scale
Time frame: Within 6 Days
Pharmacodynamic (Photography)
Photographs of treatment sites will be taken
Time frame: Within 2 Weeks
Pharmacodynamic (Thermography)
Skin temperature measurements will be taken
Time frame: Within 2 Weeks
Local tolerability
Visual Analogue Scale (NRS) pruritus and pain
Time frame: 2 Weeks
Safety (AE)
Adverse Events will be collected throughout the study
Time frame: 2 Weeks
Safety (Vital Signs)
Vital Signs will be collected throughout the study
Time frame: 2 Weeks
Safety (Laboratory Safety Testing)
Lab samples collected in various timepoints within the study
Time frame: 2 Weeks
Safety (ECG)
ECGs will be collected before beginning and end of study
Time frame: Within 3 Weeks
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Maruho Co., Ltd.