A study designed to explore reaction of the skin of healthy volunteers to Imiquimod cream.
- Conditions
- none, this is a study on healthy volunteersMedDRA version: 18.1Level: LLTClassification code 10062249Term: Skin inflammationSystem Organ Class: 100000004858Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2016-000331-41-NL
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 16
1.Healthy male subjects, 18 to 45 years of age (inclusive). The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease following a detailed medical history and a complete physical examination including vital signs, laboratory measurements and 12-lead ECG. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
2.Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum bodyweight of 50 kg.
3.Fitzpatrick Skin type I-II (Caucasian type).
4.Willing to give written informed consent and willing and able to comply with the study protocol.
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
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 relevant skin condition.
5.Previous use of imiquimod / resiquimod / gardiquimod
6.Known hypersensitivity to the investigational drug, comparative drug, drugs of the same class, or any of their excipients.
7.Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study.
8.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
9.Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment.
10.Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
11.Loss or donation of blood over 500 mL within three months prior to screening.
12.Any (medical) condition that would, in the opinion of the investigator, potentially compromise the safety or compliance of the patient or may preclude the patient’s successful completion of the clinical trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective<br>-To explore the pharmacodynamic effects of topically applied imiquimod (in combination with or without TS) <br>-To identify dose-response relationship of topically applied imiquimod<br>;Secondary Objective: Secondary objective<br>•To assess safety and tolerability of topically applied imiquimod<br>;Primary end point(s): Pharmacodynamics<br>-Local (biopsy) biomarkers (IP10/CXCL10, IFN-a, IFN-ß, IFN-? , TNF-a, , IL-1ß, IL-6, HBD-2, MX1, ICAM-1)<br>-Histology (HE)<br>-Immunohistochemistry (CD1a, HLADR, CD8+, CD4+, CD14+, CD11c)<br>-Perfusion by Laser spectrum contract imaging (LSCI)<br>-Trans epidermal water loss (TEWL)<br>-Colorimetric<br>-Clinical evaluation (erythema grading scale)<br>-Thermography<br>-Photography (2D and 3D)<br><br>;Timepoint(s) of evaluation of this end point: Day 0,1,2,3,4,7,14
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Tolerability / safety endpoints<br>•Adverse events (AEs)<br>•Vitals<br>•12-leads ECGs<br>;Timepoint(s) of evaluation of this end point: screening, day 0,1,2,3,4,7,14