Intradermal LPS and Antibiotics

• Status: Completed
• Trial end date: 2019-02-23
• Target enrollment: 0
• Participant gender: All

Summary

Erythromycin and clindamycin are believed to have anti-inflammatory aspects. This study investigates the possible anti-inflammatory effects of erythromycin and clindamycin.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre for Human Drug Research, Netherlands
• Collaborators: Cutanea Life Sciences, Inc.; Maruho Co., Ltd.
• Treatments: Anti-Bacterial Agents; Anti-Inflammatory Agents; Antibiotics, Antitubercular; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Clobetasol; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. Healthy male or 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;

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. Able and willing to give written informed consent and to comply with the study restrictions.

5. Able to work with the eDiary app.

Exclusion Criteria:

1. Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients;

2. Type 1 or type 2 diabetes mellitus;

3. Any vaccination within the last 3 months;

4. Family history of psoriasis;

5. History of pathological scar formation (keloid, hypertrophic scar);

6. Have any current and / or recurrent pathologically, clinical significant skin condition at the treatment area (i.e. atopic dermatitis);

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. 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. Or the donation of plasma within 14 days prior to screening;

12. Current smoker and/or regular user of other nicotine-containing products (e.g., patches);

13. History of or current drug or substance abuse considered significant by the PI (or medically qualified designee), including a positive urine drug screen.