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

Seborrheic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01315951
• Other study ID #: ME 10 0054
• Status: Recruiting
• Phase: N/A
• First received: March 15, 2011
• Last updated: March 15, 2011
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2011
• Source: Genesys Regional Medical Center
• Contact: Ryan D Stevenson, BS
• Phone: 810-252-4951
• Email: ryandavid26[@]yahoo.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Eczema
• Seborrheic Dermatitis

Intervention

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.

Locations

Country	Name	City	State
United States	Genesys East Flint Campus	Burton	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Genesys Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No