Skin DiseaseNCT02338076
A Study to Document the Effect of Petrolatum on Innate Immune Responses in the Skin
A study testing Petrolatum application under occlusion in people with Skin Disease, run by Rockefeller University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Disease
- What is being tested?
- Petrolatum application under occlusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female between 18 and 85 years of age
- Able to give verbal and written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Skin Disease
- Being tested
- Petrolatum application under occlusion
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Petrolatum application under occlusionDrug
Also called 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)
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | petrolatum application under occlusion Receives: Drug: Petrolatum application under occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 days
Secondary outcomes (2)
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
Measured: 3 days
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)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJun 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saakshi Khattri, Rockefeller University
- Investigators
- Emma Guttman, MD, PhD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338076
- Sponsor's protocol ID
- EGU-811
- Status last verified
- Apr 2017
- First submitted
- 9 Jan 2015
- Last updated
- 16 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Document the Effect of Petrolatum on Innate Immune Responses in the Skin
- ClinicalTrials.gov ID
- NCT02338076
- Acronym / sponsor ID
- EGU-811
- Conditions
- Skin Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Posted 16 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Drug: Petrolatum application under occlusionpetrolatum application under occlusion |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male or female between 18 and 85 years of age
- Able to give verbal and written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Petrolatum application under occlusionAlso: vaseline under occlusionDay 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) | Drug | Interventional arm |
Primary outcome
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.
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
2 secondary outcomes
Skin Thickness Difference Between Occluded Versus Occluded With Petrolatum Compared With Normal Skin.
Time frame: 3 days
T-cell Infiltrate in Occluded Versus Occluded With Petrolatum Compared With Normal Skin.
Time frame: 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Skin Disease
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Guttman, MD, PhD principal investigator
Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Petrolatum application under occlusion in people with Skin Disease, run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.