Trial Outcomes & Findings for A Study to Document the Effect of Petrolatum on Innate Immune Responses in the Skin (NCT NCT02338076)

NCT ID: NCT02338076

Last Updated: 2017-05-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 3 days
• Results posted on: 2017-05-16

Participant Flow

Participant milestones

Measure	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)
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Interventional Arm n=20 Participants 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)
Age, Categorical <=18 years	0 Participants n=113 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=113 Participants
Age, Categorical >=65 years	3 Participants n=113 Participants
Sex: Female, Male Female	8 Participants n=113 Participants
Sex: Female, Male Male	12 Participants n=113 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Interventional Arm With Petrolatum n=20 Participants 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)	Arm With Occlusion Only (Without Petrolatum) n=20 Participants 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)	Control Arm/Normal Skin n=20 Participants 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)
Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum. S100A12	8.795 log of copy number Interval 8.16 to 9.434	8.078 log of copy number Interval 7.424 to 8.732	7.586 log of copy number Interval 6.814 to 8.358
Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum. PI3	10.555 log of copy number Interval 10.07 to 11.04	8.752 log of copy number Interval 8.267 to 9.237	6.61 log of copy number Interval 6.126 to 7.095
Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum. S100A8	9.12 log of copy number Interval 8.43 to 9.811	7.025 log of copy number Interval 6.334 to 7.716	5.415 log of copy number Interval 4.724 to 6.106
Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum. S100A9	8.926 log of copy number Interval 8.275 to 9.576	6.781 log of copy number Interval 6.13 to 7.432	5.43 log of copy number Interval 4.779 to 6.081
Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum. S100A7	9.889 log of copy number Interval 9.5 to 10.476	8.883 log of copy number Interval 8.395 to 9.371	8.468 log of copy number Interval 7.959 to 8.977
Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum. LIPOCALIN	10.977 log of copy number Interval 10.365 to 11.59	9.528 log of copy number Interval 8.916 to 10.141	8.182 log of copy number Interval 7.57 to 8.794

PRIMARY outcome

Timeframe: 3 days

Outcome measures

Measure	Interventional Arm With Petrolatum n=20 Participants 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)	Arm With Occlusion Only (Without Petrolatum) n=20 Participants 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)	Control Arm/Normal Skin n=20 Participants 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)
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 IL-6	10.302 log of copy number Interval 9.681 to 10.921	9.405 log of copy number Interval 8.79 to 10.019	9.100 log of copy number Interval 8.45 to 9.749
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 IL-8	8.205 log of copy number Interval 7.569 to 8.841	6.752 log of copy number Interval 6.125 to 7.379	6.034 log of copy number Interval 5.413 to 6.655
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 IL-1B	8.920 log of copy number Interval 8.284 to 9.583	8.145 log of copy number Interval 7.454 to 8.836	7.555 log of copy number Interval 6.854 to 8.236

SECONDARY outcome

Timeframe: 3 days

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

Outcome measures

Measure	Interventional Arm With Petrolatum n=20 Participants 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)	Arm With Occlusion Only (Without Petrolatum) n=20 Participants 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)	Control Arm/Normal Skin n=20 Participants 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)
Skin Thickness Difference Between Occluded Versus Occluded With Petrolatum Compared With Normal Skin.	41 micrometer Standard Deviation 12	32 micrometer Standard Deviation 9	24 micrometer Standard Deviation 8

SECONDARY outcome

Timeframe: 3 days

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

Outcome measures

Measure	Interventional Arm With Petrolatum n=20 Participants 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)	Arm With Occlusion Only (Without Petrolatum) n=20 Participants 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)	Control Arm/Normal Skin n=20 Participants 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)
T-cell Infiltrate in Occluded Versus Occluded With Petrolatum Compared With Normal Skin.	1.8421 cells per micrometer squared Standard Deviation 4.1801	4.5263 cells per micrometer squared Standard Deviation 15.6679	0.5789 cells per micrometer squared Standard Deviation 0.6924

Adverse Events

Interventional Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Emma Guttman

Rockefeller University

Phone: 212-327-8333

Email: skhattri@rockefeller.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place