A study to investigate the immune response of the skin after application of imiquimod cream

Not Applicable

Completed

• Conditions: Imiquimod induced inflammation; Not Applicable

• Registration Number: ISRCTN15719626
• Lead Sponsor: Centre of Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-01
• Study Completion: 2022-06-30
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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, hematology, blood chemistry, blood serology and urinalysis. 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 and a minimum weight of 50 kg, inclusive
3. Fitzpatrick skin type I-III (Caucasian)
4. Female subjects of childbearing potential must use effective contraception for the duration of the study
5. Able and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria

1. History of pathological scar formation (keloid, hypertrophic scar) or keloids or surgical scars in the target treatment area that in the opinion of the investigator, would limit or interfere with dosing and/or measurement in the trial;
2. Diagnosed with psoriasis or family history of psoriasis
3. History of skin cancer (basal cell carcinoma, squamous cell carcinoma, melanoma);
4. Have any current and / or recurrent clinically significant skin condition at the treatment area (e.g. atopic dermatitis); including tattoos;
5. Using immunosuppressive or immunomodulatory medication within 30 days prior to enrolment or planned to use during the course of the study;
6. 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;
7. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
8. Loss or donation of blood over 500 mL within three months prior to screening or donation of plasma within 14 days of screening;
9. 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;
10. Any vaccination within 30 days prior to initial IMQ dosing or planned during the course of the study with exception of vaccination for SARS-CoV-2;
11. Vaccination for SARS-CoV-2 within 14 days prior to initial IMQ dosing, or planned during the course of the study;
12. Chronic infection with HIV, hepatitis B (HBV) or hepatitis C (HCV). A positive HBV surface antigen (HBsAg) test at screening excludes a subject;
13. A history of ongoing, chronic or recurrent infectious disease;
14. Current smoker and/or regular user of other nicotine-containing products (e.g., patches);
15. History of or current drug or substance abuse considered significant by the PI (or medically qualified designee), including a positive urine drug screen.
16. Previous use of Aldara (imiquimod cream) 3 months prior to the baseline visit;
17. Volunteers with clinically relevant infections
18. Hypersensitivity for dermatological marker at screening
19. Tanning due to sunbathing, excessive sun exposure or a tanning both within 3 weeks of enrollment.
20. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified