NCT03883269

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Centre for Human Drug Research, Netherlands · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The combined bacteriostatic and immunomodulatory effects of erythromycin and clindamycin will be explored. Treatment effects will be extensively characterized by conventional methods including lesion counts, global assessment scales and visual grading as well as state-of-the-art methodology, including multi-modal photo analysis, perfusion by laser speckle contrast imaging, analysis of local skin surface, biopsy biomarkers and skin microbiota. This extensive response profiling, combined with the mechanistic insights from concurrent in vitro and in vivo studies in healthy volunteer challenges, will increase the understanding of erythromycin's and clindamycin's effects in acne vulgaris.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Erythromycin 4% topical gel formulation	Erythromycin 4% topical gel formulation, BID, 4 weeks
DRUG	Clindamycin 1% topical lotion formulation	Clindamycin 1% topical lotion formulation, BID, 4 weeks
DRUG	70% topical ethanol solution	70% topical ethanol solution, BID, 4 weeks

Timeline

• Start date: 2018-03-20
• Primary completion: 2019-06-01
• Completion: 2019-12-01
• First posted: 2019-03-20
• Last updated: 2019-03-20

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study