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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02338076
Recruitment Status : Completed
First Posted : January 14, 2015
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Information provided by (Responsible Party):
Saakshi Khattri, Rockefeller University

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.

Condition or disease Intervention/treatment Phase
Skin Disease Drug: Petrolatum application under occlusion Not Applicable

Detailed Description:

Petrolatum (also commonly called Vaseline) is a very well known moisturizer 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. It is widely used by Dermatologists as a substance to apply to wounds from cutaneous surgical procedures. In a large study, petrolatum was shown to be as effective as one of the major topical antibiotics to help prevent infection in patients who underwent dermatologic procedures. Not only are the other topical antibiotics expensive, but also they are commonly the cause of an allergic reaction in up to 10% of the population. Until now, no reason has been found to explain why petrolatum is effective in infection prevention. In a recent study, skin biopsies of skin that had petrolatum applied to them were obtained. Upon analysis certain "antimicrobial peptides" (peptides that possess anti-bacterial properties that help fight infection) have been found to be elevated. This could provide an answer as to why petrolatum was as effective as the topical antibiotic in the study mentioned above.

This study hopes to improve our understanding of how the immune system acts and how the skin responds to petrolatum. In order to reach this goal, normal volunteers, will be patch tested with petrolatum. Then, biopsies will be taken of the skin at the sites where petrolatum was. Also, small biopsies will be taken from an area that received a patch but no petrolatum and an area that did not receive a patch to serve as controls. The biopsied skin samples will then be studied in a laboratory by methods such as immunohistochemistry and RT-PCR analysis, which will help define the response of the immune system to petrolatum. The rationale for the study is to better define petrolatum's effects in skin and how it is effective at preventing infections.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Study to Document the Effect of Petrolatum on Innate Immune Responses in the Skin
Study Start Date : June 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions
Drug Information available for: Petrolatum

Arm Intervention/treatment
Experimental: Interventional arm
petrolatum application under occlusion
Drug: Petrolatum application under occlusion

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)

Other Name: vaseline under occlusion

Primary Outcome Measures :
  1. Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum. [ Time Frame: 3 days ]
    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.

  2. 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 [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Skin Thickness Difference Between Occluded Versus Occluded With Petrolatum Compared With Normal Skin. [ Time Frame: 3 days ]
    skin thickness difference between occluded skin biopsy versus occluded with petrolatum skin biopsy compared with normal skin biopsy was examined

  2. T-cell Infiltrate in Occluded Versus Occluded With Petrolatum Compared With Normal Skin. [ Time Frame: 3 days ]
    t-cell infiltrate in occluded skin versus occluded with petrolatum skin compared with normal skin ( healthy/not occluded skin)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02338076

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United States, New York
The Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
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Principal Investigator: Emma Guttman, MD, PhD Rockefeller University
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Responsible Party: Saakshi Khattri, Sub-investigator, Rockefeller University Identifier: NCT02338076    
Other Study ID Numbers: EGU-811
First Posted: January 14, 2015    Key Record Dates
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Skin Diseases
Dermatologic Agents