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TerminatedNCT01315951Updated May 20, 2024

Petrolatum's Effect on Initial Symptoms of Nonscalp Seborrheic Dermatitis and Preventing Exacerbation

An interventional study of Petroleum Jelly in Seborrheic Dermatitis, sponsored by Ascension Health. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-20.

Sponsored by Ascension Health · Not applicable, Interventional, and Treatment

Why this study was terminated
PI Ryan D Stevenson left Organization (Genesys) prior to Ascension acquiring record; no evidence of completion
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study summary

The goal of this research is to demonstrate the use of petroleum jelly in prevention of nonscalp seborrheic dermatitis exacerbations at the first signs of a flare. In doing so, it will decrease the chronic use of topical steroids. The use of petrolatum should have favorable outcomes for patients, without the side-effects.

Read the detailed description

Nonscalp seborrheic dermatitis (NSSD) is typically a benign inflammatory process of the skin that affects oil rich areas including in and between eyebrows, paranasal area, behind ears, over the sternum, and groin. While these lesions typically come and go without proposing a threat to the patient, they can be socially debilitating, and psychologically distressing.

The mainstay treatment for an exacerbation of NSSD is topical steroids. Topical steroids are very effective and useful to patient's who are desperately seeking treatment. However, most family practitioners are reluctant to prescribe or recommend topical steroids for chronic conditions like NSSD due to the potential side-effects including permanent atrophy of the skin.

NSSD has an unknown etiology. However, one of its biggest risk factors appears to be dry skin due to its increase in incidence during colder seasons, and with use of alcohol-containing topicals. Naturally occurring skin yeast (ie Malassezia) are also thought to play a part.

Petrolatum is considered a skin protectant and has a strong ability to hold moisture in skin. Along with restricting water from leaving skin, it also decreases most air from contacting the skin. This may slow the growth and activity of skin yeast that are typically considered facultative anaerobes.

A patient diagnosed with nonscalp seborrheic dermatitis will be consented into the study and given instructions on the petroleum treatment. This includes wetting the affected area, blotting dry, and then applying petrolatum to the area before bedtime. This regimen is to be followed every other night until symptoms diminish. The patient will come back to the office for follow-up at one week, two weeks, and four weeks after treatment begins to see the outcome. Pictures will be taken at each encounter and used to measure progress through one mm graphs. Patients will not be identifiable in these pictures, and they will be labeled with the patient's given ID number.

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Conditions studied

  • Seborrheic Dermatitis

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Keywords

  • Non scalp Seborrheic Dermatitis
03

In context

Dermatitis, Seborrheic

54 studies on the registry are indexed under Dermatitis, Seborrheic; 7 are open to participants now.

This study's enrollment of 3 is below the median of 80 across 45 interventional studies indexed under Dermatitis, Seborrheic.

Browse Dermatitis, Seborrheic studies →

Lead sponsor

Ascension Health is the lead sponsor of 21 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-75 years old who are patients of the Genesys East Flint Clinic and have been diagnosed with recurrent NSSD
  • Patients are to use the petrolatum treatment strictly for the initial symptoms of NSSD: Excessive flaking, and erythematous macules or papules
  • Patients who are able to attend the follow-up appointments for assessment
  • Patients are to have the doctor's confidence that that patient will correctly implement the treatment plan

Exclusion criteria

Exclusion Criteria:

  • Patients not in the 18-75 years of age range.
  • Patients who are receiving treatment for their seborrheic dermatitis (Scalp or nonscalp) elsewhere.
  • Patients who have not demonstrated recurrent NSSD.
  • Patients who are unable to commit to a follow-up appointments for assessment.
  • Patients who do not have the physician's confidence in implementing the studies treatment plan effectively.
  • Patient's who are unable/unwilling to have petrolatum on affected area for at least a 6 hour length of time.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Petroleum Jelly

    Every patient will be applying petroleum jelly to the affected areas per protocol.

    Biological: Petroleum Jelly

Interventions

  • BiologicalPetroleum Jelly

    Every patient will be instructed to wet the affected area, blot dry, and then apply petroleum jelly to the area before bedtime. This regimen is to be followed every other night until symptoms diminish. The patient should follow-up at one week, two weeks, and four weeks after treatment begins to see the outcome.

    Also known as: Petrolatum, Vaseline

06

What researchers measure

Primary outcomes

  1. Measuring the Effectiveness of Petroleum Jelly in Treating Nonscalp Seborrheic Dermatitis

    Petroleum jelly will be applied to the areas of the face affected by Nonscalp Seborrheic Dermatitis every other night for four weeks. Patients will be seen in the office at one week, two weeks, and one month during the course of the treatment. Pictures will be taken at each visit to determine the progress of the treatment.

    Time frame: 4 weeks

Secondary outcomes

  1. Patient Satisfaction ofTreatment

    Patients will be surveyed initially when they are consented asking about their personal history of nonscalp seborrheic dermatitis including triggers and previous and current treatment measures.

    Time frame: 4 weeks

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Study locations

1 site
  • Genesys East Flint Campus
    Burton, Michigan 48509, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01315951
Lead sponsor
Ascension Health
Responsible party
Jackie Kirchen (Director research integrity and compliance, Ascension Health) — Principal investigator
First posted
Mar 16, 2011
Start date
Mar 2011
Primary completion
Feb 2012
Completion
Mar 2012
Last update
May 20, 2024

Study contacts

Ryan D Stevenson, BS
principal investigator · Ascension Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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