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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02338076
Enrollment
20
Registered
2015-01-14
Start date
2013-06-30
Completion date
2015-02-28
Last updated
2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Disease

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.

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.

Interventions

DRUGPetrolatum 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)

Sponsors

Rockefeller University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.3 daysThe 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 Expression3 days

Secondary

MeasureTime frameDescription
Skin Thickness Difference Between Occluded Versus Occluded With Petrolatum Compared With Normal Skin.3 daysskin 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 dayst-cell infiltrate in occluded skin versus occluded with petrolatum skin compared with normal skin ( healthy/not occluded skin)

Countries

United States

Participant flow

Participants by arm

ArmCount
Interventional Arm
petrolatum application under occlusion 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)
20
Total20

Baseline characteristics

CharacteristicInterventional Arm
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
3 Participants
Age, Categorical
Between 18 and 65 years
17 Participants
Sex: Female, Male
Female
8 Participants
Sex: Female, Male
Male
12 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 20
serious
Total, serious adverse events
0 / 20

Outcome results

Primary

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.

Time frame: 3 days

ArmMeasureGroupValue (MEAN)
Interventional Arm With PetrolatumExpression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.S100A89.12 log of copy number
Interventional Arm With PetrolatumExpression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.S100A98.926 log of copy number
Interventional Arm With PetrolatumExpression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.S100A79.889 log of copy number
Interventional Arm With PetrolatumExpression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.LIPOCALIN10.977 log of copy number
Interventional Arm With PetrolatumExpression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.S100A128.795 log of copy number
Interventional Arm With PetrolatumExpression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.PI310.555 log of copy number
Arm With Occlusion Only (Without Petrolatum)Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.PI38.752 log of copy number
Arm With Occlusion Only (Without Petrolatum)Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.S100A87.025 log of copy number
Arm With Occlusion Only (Without Petrolatum)Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.LIPOCALIN9.528 log of copy number
Arm With Occlusion Only (Without Petrolatum)Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.S100A128.078 log of copy number
Arm With Occlusion Only (Without Petrolatum)Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.S100A96.781 log of copy number
Arm With Occlusion Only (Without Petrolatum)Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.S100A78.883 log of copy number
Control Arm/Normal SkinExpression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.S100A95.43 log of copy number
Control Arm/Normal SkinExpression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.S100A78.468 log of copy number
Control Arm/Normal SkinExpression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.PI36.61 log of copy number
Control Arm/Normal SkinExpression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.LIPOCALIN8.182 log of copy number
Control Arm/Normal SkinExpression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.S100A85.415 log of copy number
Control Arm/Normal SkinExpression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.S100A127.586 log of copy number
Primary

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

ArmMeasureGroupValue (MEAN)
Interventional Arm With PetrolatumMeasurement 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 ExpressionIL-88.205 log of copy number
Interventional Arm With PetrolatumMeasurement 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 ExpressionIL-610.302 log of copy number
Interventional Arm With PetrolatumMeasurement 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 ExpressionIL-1B8.920 log of copy number
Arm With Occlusion Only (Without Petrolatum)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 ExpressionIL-86.752 log of copy number
Arm With Occlusion Only (Without Petrolatum)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 ExpressionIL-69.405 log of copy number
Arm With Occlusion Only (Without Petrolatum)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 ExpressionIL-1B8.145 log of copy number
Control Arm/Normal SkinMeasurement 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 ExpressionIL-69.100 log of copy number
Control Arm/Normal SkinMeasurement 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 ExpressionIL-1B7.555 log of copy number
Control Arm/Normal SkinMeasurement 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 ExpressionIL-86.034 log of copy number
Secondary

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

skin thickness difference between occluded skin biopsy versus occluded with petrolatum skin biopsy compared with normal skin biopsy was examined

Time frame: 3 days

ArmMeasureValue (MEAN)Dispersion
Interventional Arm With PetrolatumSkin Thickness Difference Between Occluded Versus Occluded With Petrolatum Compared With Normal Skin.41 micrometerStandard Deviation 12
Arm With Occlusion Only (Without Petrolatum)Skin Thickness Difference Between Occluded Versus Occluded With Petrolatum Compared With Normal Skin.32 micrometerStandard Deviation 9
Control Arm/Normal SkinSkin Thickness Difference Between Occluded Versus Occluded With Petrolatum Compared With Normal Skin.24 micrometerStandard Deviation 8
Secondary

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

t-cell infiltrate in occluded skin versus occluded with petrolatum skin compared with normal skin ( healthy/not occluded skin)

Time frame: 3 days

ArmMeasureValue (MEAN)Dispersion
Interventional Arm With PetrolatumT-cell Infiltrate in Occluded Versus Occluded With Petrolatum Compared With Normal Skin.1.8421 cells per micrometer squaredStandard Deviation 4.1801
Arm With Occlusion Only (Without Petrolatum)T-cell Infiltrate in Occluded Versus Occluded With Petrolatum Compared With Normal Skin.4.5263 cells per micrometer squaredStandard Deviation 15.6679
Control Arm/Normal SkinT-cell Infiltrate in Occluded Versus Occluded With Petrolatum Compared With Normal Skin.0.5789 cells per micrometer squaredStandard Deviation 0.6924

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026