Pro-Resolving Mediators in Acute Inflammation in Humans

NCT04308889 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: 2017P0008362P01GM095467-06
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Specialized pro-resolving mediators

Outcome Measures

Primary Outcomes (1)

• Specialized Pro-Resolving Mediators in Acute Inflammation

  Specialized Pro-Resolving Mediators (SPMs) in a participant's peripheral blood and blister fluid will be extracted and analyzed by targeted metabolo-lipidomics with liquid chromatography - tandem mass spectrometry to identify and quantify SPMs and related bioactive lipid mediators, namely leukotrienes and prostaglandins. Note that these fatty acids and bioactive mediators in blister exudates and peripheral blood will have the same units of measure.

  24 hours after blister induction

Secondary Outcomes (4)

• Inflammatory Cells in Acute Blister Exudates

  Change from 24 to 72 hours after blister induction

• Inflammatory Cell Changes During Resolution of Acute Inflammation

  Change from 24 to 72 hours after blister induction

• Peripheral Blood Inflammatory Cells During Acute Inflammation and Resolution

  Change from baseline to 24 hours and then to 72 hours after blister induction

• Specialized Pro-Resolving Mediator Levels During Resolution of Acute Inflammation

  Change from 24 hours to 72 hours after blister induction

Other Outcomes (1)

• Laser Speckled Contrast Imaging During Acute Inflammation and Resolution

  Change from baseline to 24 hours and then to 72 hours after blister induction

Study Arms (2)

Without Supplementation

ACTIVE COMPARATOR

No planned dietary supplementation

Other: Cantharone; Other: Phlebotomy

With Supplementation

EXPERIMENTAL

The subject will take 4 capsules (1gram each) of Lovaza daily at 8pm, starting the evening before blister induction and continuing until the second blister fluid has been removed.

Drug: Lovaza; Other: Cantharone; Other: Phlebotomy

Interventions

Lovaza DRUG

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

Also known as: omega-3 fatty acid ethyl esters

With Supplementation

Cantharone OTHER

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.

With Supplementation; Without Supplementation

Phlebotomy OTHER

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

With Supplementation; Without Supplementation

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults
• Ages 18-64

You may not qualify if:

• Known acute or chronic infection
• Known acute or chronic disease of any kind
• Known allergy to fish or shellfish
• Use of any prescription medication
• Use of over-the-counter medication except multivitamins
• Use of dietary or herbal supplement except protein supplements
• Women that are pregnant, trying to become pregnant, or breastfeeding
• Any skin disease
• Known immunocompromise, HIV, or Diabetes mellitus
• History of cardiopulmonary disease
• History of upper extremity cellulitis
• Significant allergy of any kind
• Known bleeding diathesis
• History of keloid scar formation
• Forearm tattoo

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Dermatitis; Blister

Interventions

Omacor; Phlebotomy

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Bruce D Levy, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects will participate in a total of 6 study visits clustered into two groups of 3 visits (baseline, 24h and 72h after blister induction) for a total of 72 hours duration. The crossover for each group of 3 visits will be separated by at least 1 week.

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 16, 2020
• Study Start: July 2, 2018
• Primary Completion: February 3, 2022
• Study Completion: February 22, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)