NL-OMON43402CompletedNot Applicable
A randomized, open-label, vehicle-controlled, parallel-cohort, dose-ranging study to explore the pharmacodynamics of topically applied imiquimod in healthy volunteers - Topical challenge with imiquimod in healthy volunteers
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 16
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •* Healthy male subjects, 18 to 45 years of age, inclusive
- •* Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg
- •* Fitzpatrick Skin type I-II (Caucasian type)
- •* Able to participate and willing to give written informed consent and to comply with the study restrictions.
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 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.
Investigators
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