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

Launched by CENTRE FOR HUMAN DRUG RESEARCH, NETHERLANDS · Mar 18, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two topical medications, erythromycin and clindamycin, on acne vulgaris, which is a common skin condition characterized by pimples and inflammation. The researchers want to understand how these treatments work to reduce acne by looking at various factors, such as the number of acne lesions and changes in the skin. They will also use advanced techniques to analyze skin samples and the bacteria living on the skin to gain deeper insights into how these medications help improve acne.

To participate in this study, you need to be a healthy adult aged 18 to 45 with mild to moderate inflammatory acne on your face. You should have at least five pimples and have had acne for at least six months. Participants will undergo some evaluations and may need to provide small skin samples. If you have severe acne that requires systemic treatment or have used certain medications recently, you may not be eligible. This trial is currently recruiting participants, and it aims to gather important information about how these treatments can help manage acne effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy male and female subjects, 18 to 45 years of age. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AV following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and 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 study restrictions.
• • 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 prior to baseline
• • 3. Use of any oral/systemic treatment for acne, including oral antibiotics, excluding OAC, 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 any of 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 of enrollment.
• • 9. Participation in an investigational drug or device study within 3 months prior to screening 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