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

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.

• Petrolatum application under occlusion (Drug), also known as vaseline 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)

Primary outcomes

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

• Skin Thickness Difference Between Occluded Versus Occluded With Petrolatum Compared With Normal Skin. [3 days]: skin thickness difference between occluded skin biopsy versus occluded with petrolatum skin biopsy compared with normal skin biopsy was examined
• T-cell Infiltrate in Occluded Versus Occluded With Petrolatum Compared With Normal Skin. [3 days]: t-cell infiltrate in occluded skin versus occluded with petrolatum skin compared with normal skin ( healthy/not occluded skin)

Sex: All, ages: 18 Years to 85 Years, accepts healthy volunteers

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

Participant flow

Outcome results

• Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum. (Primary), Mean, log of copy number: Interventional Arm With Petrolatum 9.12 (8.430 to 9.811); Arm With Occlusion Only (Without Petrolatum) 7.025 (6.334 to 7.716); Control Arm/Normal Skin 5.415 (4.724 to 6.106)
• 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 (Primary), Mean, log of copy number: Interventional Arm With Petrolatum 10.302 (9.681 to 10.921); Arm With Occlusion Only (Without Petrolatum) 9.405 (8.790 to 10.019); Control Arm/Normal Skin 9.100 (8.450 to 9.749)
• Skin Thickness Difference Between Occluded Versus Occluded With Petrolatum Compared With Normal Skin. (Secondary), Mean, micrometer: Interventional Arm With Petrolatum 41 +/- 12; Arm With Occlusion Only (Without Petrolatum) 32 +/- 9; Control Arm/Normal Skin 24 +/- 8
• T-cell Infiltrate in Occluded Versus Occluded With Petrolatum Compared With Normal Skin. (Secondary), Mean, cells per micrometer squared: Interventional Arm With Petrolatum 1.8421 +/- 4.1801; Arm With Occlusion Only (Without Petrolatum) 4.5263 +/- 15.6679; Control Arm/Normal Skin 0.5789 +/- 0.6924

Adverse events

• Emma Guttman, MD, PhD, Principal investigator, Rockefeller University