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Pro-Resolving Mediators in Acute Inflammation in Humans

NCT04308889 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-05-26

No results posted yet for this study

Summary

The investigators are undertaking a clinical blister model with or without dietary supplementation with omega-3 fatty acids (i.e., Lovaza) to determine the role of specialized pro-resolving mediators - endogenous lipids converted from omega-3 fatty acid precursors including those in Lovaza - on inflammation parameters and their resolution.

Conditions

  • Inflammation; Skin
  • Resolution
  • Blister

Interventions

DRUG

Lovaza

Lovaza contains ethyl esters of omega-3 fatty acids (EPA and DHA) obtained from the oil of several fish sources.

OTHER

Cantharone

Cantharone is a clinical blistering agent for topical use to remove warts and molluscum contagiosum. We plan to use the drug to elicit a small skin blister and inflammatory response. This is a well described clinical inflammation research experimental model with multiple publications of its safety and utility in tracking the host inflammatory response.

OTHER

Phlebotomy

Subjects will have blood drawn from the antecubital vein for not more than 15mL at each visit.

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Bruce D Levy, MD · Brigham and Women's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-07-02
Primary Completion
2022-02-03
Completion
2022-02-22
FDA Drug
Yes

Countries

  • United States

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 NCT04308889 on ClinicalTrials.gov