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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Genesys Regional Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Genesys Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01315951
First received: March 15, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Seborrheic Dermatitis
Biological: Petroleum Jelly

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Petrolatum's Effect on Initial Symptoms of Nonscalp Seborrheic Dermatitis and Preventing Exacerbation

Resource links provided by NLM:


Further study details as provided by Genesys Regional Medical Center:

Primary Outcome Measures:
  • Measuring the Effectiveness of Petroleum Jelly in Treating Nonscalp Seborrheic Dermatitis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Patient Satisfaction ofTreatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 8
Study Start Date: March 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Petrolatum, Vaseline

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315951

Contacts
Contact: Ryan D Stevenson, BS 810-252-4951 ryandavid26@yahoo.com
Contact: Lauren E Suchy, BS, MPA 810-606-7878 lauren.suchy@genesys.org

Locations
United States, Michigan
Genesys East Flint Campus Recruiting
Burton, Michigan, United States, 48509
Contact: Ryan D Stevenson, BS    810-252-4951    ryandavid26@yahoo.com   
Contact: Lauren E Suchy, BS, MPA    810-606-7878    lauren.suchy@genesys.org   
Principal Investigator: Ryan D Stevenson, DS         
Sponsors and Collaborators
Genesys Regional Medical Center
Investigators
Principal Investigator: Ryan D Stevenson, BS Genesys Regional Medical Center
  More Information

No publications provided

Responsible Party: Ryan Stevenson Medical Student, Michigan State University College of Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT01315951     History of Changes
Other Study ID Numbers: ME 10 0054
Study First Received: March 15, 2011
Last Updated: March 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Genesys Regional Medical Center:
Non scalp Seborrheic Dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Petrolatum
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014