A Study to Document the Effect of Petrolatum on Innate Immune Responses in the Skin

NCT02338076 | Completed Results

• 1 other identifier: EGU-811
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Petrolatum is a very well-known emollient that has been used since the 1800's. Not only has it been used to help with dry skin, but it is also marketed as a substance that protects minor cuts and burns. In the past it was thought to be inferior to topical antibiotics in infection prevention for cutaneous wounds. However, in 1996 a large, multicenter trial including over 900 patients showed that petrolatum is as safe and effective as the topical antibiotic, bacitracin in preventing infections for patients undergoing dermatological surgery. In this trial, not only did the petrolatum group have similarly low rates of infection, this group also reported no cases of contact dermatitis. Aside from being more expensive than petrolatum, bacitracin and other topical antimicrobials (i.e. neomycin) have been known as common culprits of contact dermatitis. In a study done by the North American Contact Dermatitis Group between 2005-2006, 9.2 and 10% of the over 4,000 patients who were patch tested had an allergic reaction to either bacitracin or neomycin, respectively. For the above reasons, it is clear that petrolatum is an appealing alternative to topical antibiotics for infection prevention in patients undergoing dermatological procedures. This study however lacked any mechanistic analyses to provide molecular insight as to how petrolatum was effective at infection prevention. The aim of this research is to study the effect of petrolatum on innate immune reactions in the skin. In particular, petrolatum's effect on various antimicrobial peptides after contact with the skin for 3 days will be examined. This will be done through immunohistochemistry for various cellular infiltrates as well as mRNA gene expression via RT-PCR analysis for inflammatory and AMP genes. Tissue samples of petrolatum occluded skin will be compared to both healthy skin and skin under occlusion alone as controls. These comparisons will isolate the effect of the petrolatum on the skin.

Conditions

Skin Disease

Outcome Measures

Primary Outcomes (2)

• Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.

  The levels of expression of antimicrobial peptides (S100A8, S100A9, CCL20, PI3, lipocalin , human β-defensin 2 will be measured in skin biopsy samples with petrolatum occlusion, normal skin and occlusion without petrolatum to see if there is any difference in expression Please note- There is only 1 arm with 3 measures - for example, subject 1 had 3 biopsies and the outcome measure S100A8, S100A9, PI3, LIPOCALCIN, HUMAN B DEFENSIN were tested in all 3 biopsies. This is reported as the log of the number of copies. HUMAN B DEFENSIN and CCL20 was not collected. S100A7 and S100A12 were added to the analysis.

  3 days

• Measurement of Innate Immune Genes (IL6, IL8, and IL1B) in Skin Biopsy Samples With Petrolatum Occlusion, Normal Skin and Occlusion Without Petrolatum to See if There is Any Difference in Expression

  3 days

Secondary Outcomes (2)

• Skin Thickness Difference Between Occluded Versus Occluded With Petrolatum Compared With Normal Skin.

  3 days

• T-cell Infiltrate in Occluded Versus Occluded With Petrolatum Compared With Normal Skin.

  3 days

Study Arms (1)

Interventional arm

EXPERIMENTAL

petrolatum application under occlusion

Drug: Petrolatum application under occlusion

Interventions

Petrolatum application under occlusion DRUG

Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells) 1 well will be empty and the other well will contain petrolatum Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch 1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)

Also known as: vaseline under occlusion

Interventional arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female between 18 and 85 years of age
• Able to give verbal and written informed consent

You may not qualify if:

• Subjects taking any of the following systemic or topical therapies (on the back) within 2 weeks of enrollment: corticosteroids, immunosuppressants, and/or any other medications that may affect the outcome of the study
• subjects with history of keloids
• subjects with self reported history of hepatitis B or C
• HIV positive

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Emma Guttman
• Organization: Rockefeller University

skhattri@rockefeller.edu

212-327-8333

Study Officials

• Emma Guttman, MD, PhD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-investigator

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 14, 2015
• Study Start: June 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 16, 2017
• Results First Posted: May 16, 2017

Record last verified: 2017-04

Locations

US (1)