Healthy
Conditions
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.
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
Sponsors
Maruho Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamic (Thermography) | Within 2 Weeks | Skin temperature measurements will be taken |
| 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 |
| Clinical Evaluation | 6 Days | Erythema grading scale |
| Pharmacodynamic (Biomarkers) | Within 2 Weeks | Local biomarker sequencing |
| Pharmacodynamic (Histology) | Within 2 Weeks | Histological parameters assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Local tolerability | 2 Weeks | Visual Analogue Scale (NRS) pruritus and pain |
Countries
Netherlands
Outcome results
None listed