Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients

Inclusion Criteria:

1. Healthy male and female subjects, 18 to 45 years of age. The health status is verifiedby absence of evidence of any clinical significant active or uncontrolled chronicdisease other than AV following a detailed medical history, a complete physicalexamination including vital signs, 12-lead ECG, hematology, blood chemistry, virologyand urinalysis;

2. Mild to moderate inflammatory acne vulgaris on the face, ≥5 inflammatory lesions (papules and/or pustules), present at screening and baseline visit

3. A maximum of 5 nodules present at screening and baseline visit

4. Inflammatory acne present for at least 6 months

5. Fitzpatrick skin type I-II (Caucasian)

6. Able and willing to give written informed consent and to comply with the studyrestrictions.

7. Willing to comply with 2x2mm facial skin punch biopsies

Exclusion Criteria:

1. Severe acne where systemic treatment is needed

2. Use of any topical (anti-acne) medication (prescription or OTC) within 2 weeks priorto baseline

3. Use of any oral/systemic treatment for acne, including oral antibiotics, excludingOAC, within 4 weeks prior to baseline

4. Use of systemic isotretinoin within 6 months prior to baseline

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

6. Known hypersensitivity to erythromycin or clindamycin, drugs of the same class, or anyof their excipients.

7. Known contact dermatitis reaction to any product

8. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks ofenrollment.

9. Participation in an investigational drug or device study within 3 months prior toscreening or more than 4 times a year.

10. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening

11. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding