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

Primary Purpose

Seborrheic Dermatitis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Petroleum Jelly
Sponsored by
Ascension Genesys Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seborrheic Dermatitis focused on measuring Non scalp Seborrheic Dermatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Genesys East Flint CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Petroleum Jelly

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 15, 2011
Last Updated
March 15, 2011
Sponsor
Ascension Genesys Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01315951
Brief Title
Petrolatum's Effect on Initial Symptoms of Nonscalp Seborrheic Dermatitis and Preventing Exacerbation
Official Title
Petrolatum's Effect on Initial Symptoms of Nonscalp Seborrheic Dermatitis and Preventing Exacerbation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ascension Genesys Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Dermatitis
Keywords
Non scalp Seborrheic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Petroleum Jelly
Arm Type
Experimental
Arm Description
Every patient will be applying petroleum jelly to the affected areas per protocol.
Intervention Type
Biological
Intervention Name(s)
Petroleum Jelly
Other Intervention Name(s)
Petrolatum, Vaseline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measuring the Effectiveness of Petroleum Jelly in Treating Nonscalp Seborrheic Dermatitis
Description
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 Outcome Measure Information:
Title
Patient Satisfaction ofTreatment
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan D Stevenson, BS
Phone
810-252-4951
Email
ryandavid26@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren E Suchy, BS, MPA
Phone
810-606-7878
Email
lauren.suchy@genesys.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan D Stevenson, BS
Organizational Affiliation
Ascension Genesys Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesys East Flint Campus
City
Burton
State/Province
Michigan
ZIP/Postal Code
48509
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan D Stevenson, BS
Phone
810-252-4951
Email
ryandavid26@yahoo.com
First Name & Middle Initial & Last Name & Degree
Lauren E Suchy, BS, MPA
Phone
810-606-7878
Email
lauren.suchy@genesys.org
First Name & Middle Initial & Last Name & Degree
Ryan D Stevenson, DS

12. IPD Sharing Statement

Learn more about this trial

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

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