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A Randomized, Placebo-controlled, Evaluator-blinded, Study to Assess the Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Patients With Inflammatory Facial Acne
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.
Age
18 - 45 years
Sex
ALL
Healthy Volunteers
Yes
Centre for Human Drug Research
Leiden, Netherlands
Start Date
March 20, 2018
Primary Completion Date
June 1, 2019
Completion Date
December 1, 2019
Last Updated
March 20, 2019
30
ESTIMATED participants
Erythromycin 4% topical gel formulation
DRUG
Clindamycin 1% topical lotion formulation
DRUG
70% topical ethanol solution
DRUG
Lead Sponsor
Centre for Human Drug Research, Netherlands
Collaborators
NCT07205107
NCT05891795
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06501560