Effects of topical erythromycin and clindamycin on acne

A Randomized, Placebo-controlled, Evaluator-blinded, Study to Assess the Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Patients With Inflammatory Facial Acne

This study is testing whether using both erythromycin and clindamycin creams can help people with acne clear their skin better than using just one of the treatments.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Centre for Human Drug Research, Netherlands (Academic / other)
• Locations: 1 site (Leiden)
• Trial ID: NCT03883269 on ClinicalTrials.gov

What this trial studies

This study investigates the combined effects of topical erythromycin and clindamycin on patients with acne vulgaris. It will utilize both conventional assessment methods, such as lesion counts and global assessment scales, as well as advanced techniques like multi-modal photo analysis and laser speckle contrast imaging. The goal is to gain a deeper understanding of how these treatments affect acne through extensive response profiling and mechanistic insights from in vitro and in vivo studies. Participants will undergo skin biopsies to analyze local skin surface and microbiota.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 45 with mild to moderate inflammatory acne vulgaris.

Not a fit: Patients with severe acne requiring systemic treatment or those using anti-acne medications within the last two weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new insights into effective topical treatments for acne vulgaris.

How similar studies have performed: Other studies have shown promise in using topical antibiotics for acne treatment, but this specific combination and methodology may offer novel insights.

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

Where this trial is running

Leiden

• Centre for Human Drug Research — Leiden, Netherlands (Recruiting)

Study contacts

• Principal investigator: Robert Rissmann, PharmD, PhD — Chdr
• Study coordinator: Robert Rissmann, PharmD, PhD

Conditions Acne Vulgaris