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

NCT03883269 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-03-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Maruho Co., Ltd.

    collaborator INDUSTRY

  • Centre for Human Drug Research, Netherlands

    lead OTHER

Principal Investigators

  • Robert Rissmann, PharmD, PhD · CHDR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2019-06-30
Completion
2019-12-31
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03883269 on ClinicalTrials.gov