None MedDRA version: 19.1 Level: LLT Classification code 10062249 Term: Skin inflammation System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Aldara 5%
Product Name: Aldara
Pharmaceutical Form: Cream
INN or Proposed INN: IMIQUIMOD
CAS Number: 99011-02-6
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concent
Sponsors
Cutanea Life Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg. 3. Fitzpatrick skin type I-III (Caucasian). 4. 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. 5. Able and willing to give written informed consent and to comply with the study restrictions. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients 2. Family history of psoriasis 3. History of pathological scar formation (keloid, hypertrophic scar) 4. Have any current and / or recurrent pathologically, clinical significant skin condition. 5. Previous use of imiquimod/ resiquimod/ gardiquimod 6. Known hypersensitivity to the (non)investigational drug, drugs of the same class, or any of their excipients. 7. Hypersensitivity for dermatological marker at screening 8. Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study. 9. 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 10. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment. 11. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year. 12. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening 13. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective - To explore the pharmacodynamics effects of topically applied OMN on o Tape-stripped skin of healthy volunteers o Tape-stripped and IMQ-primed skin of healthy volunteers o Tape-stripped skin prior to IMQ application ;Secondary Objective: Secondary Objectives • To assess safety and tolerability of topically applied OMN in combination with IMQ ;Primary end point(s): Pharmacodynamic endpoints - Local (biopsy) biomarkers (including but not limited to IL-8, IFN-a, IFN-ß, IFN-?, MXA, MX1, IL-6, IL-10, CCL20 and HBD-2) - Histology (HE) - Immunohistochemistry (CD1a, HLADR, CD8+, CD4+, CD14+, CD11c) - Transdermal Analysis Patch (IL-8, IFN-a, IL-6, IL-10, CCL20 and HBD-2) - Perfusion by Laser speckle contrast imaging (LSCI) - Colorimetry - Clinical evaluation (erythema grading scale) - Photography (total body imaging); erythema index - Thermography - Skin microbiome (healthy and treated skin) ;Timepoint(s) of evaluation of this end point: Day 0, 1, 2, 3, 4, 5, 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tolerability / safety endpoints Adverse events (AEs) - Vital signs - 12-leads ECGs - Local tolerance (Visual Analogue Scale (NRS) pruritus and pain) - Circulating cytokines (IFN-a, IFN-?) ;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Netherlands
Contacts
Public ContactJ. Burggraaf
Centre for Human Drug Research
Outcome results
None listed