Immunological characterization of TLR-7 mediated inflammation and complement activation after prolonged Imiquimod exposure in healthy volunteers

Completed

• Conditions: Inflammation; 10027665; complement activation; 10014982

• Registration Number: NL-OMON51378
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• 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. Subjects and their partners 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

Eligible subjects must meet none of the following exclusion criteria at
screening:
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

Primary Outcome Measures

Name	Time	Method
<p>* Cytokines and immune cells in skin biopsies<br /><br>* Local complement factors in skin biopsies<br /><br>* Complement factors and activation markers in blood samples</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Perfusion by LSCI<br /><br>* Erythema by Antera 3D and clinical evaluation</p><br>