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

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.

Study Overview

• Status: Unknown
• Conditions: Seborrheic Dermatitis
• Intervention / Treatment: Biological: Petroleum Jelly

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.

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ryan D Stevenson, BS; Phone Number: 810-252-4951; Email: ryandavid26@yahoo.com
• Study Contact Backup: Name: Lauren E Suchy, BS, MPA; Phone Number: 810-606-7878; Email: lauren.suchy@genesys.org

Study Locations

• United States
  • Michigan
    • Burton, Michigan, United States, 48509
      • Recruiting
      • Genesys East Flint Campus
      • Contact: Ryan D Stevenson, BS; Phone Number: 810-252-4951; Email: ryandavid26@yahoo.com
      • Contact: Lauren E Suchy, BS, MPA; Phone Number: 810-606-7878; Email: lauren.suchy@genesys.org
      • Principal Investigator: Ryan D Stevenson, DS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Petroleum Jelly; Every patient will be applying petroleum jelly to the affected areas per protocol.	Biological: Petroleum 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.; Other Names: Petrolatum, Vaseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Collaborators and Investigators

• Sponsor: Ascension Genesys Hospital
• Investigators: Principal Investigator: Ryan D Stevenson, BS, Ascension Genesys Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): February 1, 2012
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: March 15, 2011
• First Submitted That Met QC Criteria: March 15, 2011
• First Posted (Estimate): March 16, 2011

Study Record Updates

• Last Update Posted (Estimate): March 16, 2011
• Last Update Submitted That Met QC Criteria: March 15, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Non scalp Seborrheic Dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Skin Diseases, Eczematous; Sebaceous Gland Diseases; Dermatitis; Dermatitis, Seborrheic; Dermatologic Agents; Emollients; Petrolatum
• Other Study ID Numbers: ME 10 0054

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No