Seborrheic DermatitisNCT01315951
Petrolatum's Effect on Initial Symptoms of Nonscalp Seborrheic Dermatitis and Preventing Exacerbation
A study testing Petroleum Jelly in people with Seborrheic Dermatitis, run by Ascension Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- Petroleum Jelly
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Seborrheic Dermatitis
- Being tested
- Petroleum Jelly
- Keywords
- Non scalp Seborrheic Dermatitis
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Petroleum JellyBiological
Also called Petrolatum, Vaseline
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.
| Study group | Role | What they receive |
|---|---|---|
| Petroleum Jelly | Experimental | Every patient will be applying petroleum jelly to the affected areas per protocol. Receives: Biological: Petroleum Jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2012
- Study completionMar 2012
Why it stopped: PI Ryan D Stevenson left Organization (Genesys) prior to Ascension acquiring record; no evidence of completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascension Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jackie Kirchen, Ascension Health
- Investigators
- Ryan D Stevenson, BS, Principal investigator, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315951
- Sponsor's protocol ID
- ME 10 0054
- Status last verified
- May 2024
- First submitted
- 15 Mar 2011
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Petrolatum's Effect on Initial Symptoms of Nonscalp Seborrheic Dermatitis and Preventing Exacerbation
- ClinicalTrials.gov ID
- NCT01315951
- Acronym / sponsor ID
- ME 10 0054
- Conditions
- Seborrheic Dermatitis
- Keywords
- Non scalp Seborrheic Dermatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Ryan D Stevenson left Organization (Genesys) prior to Ascension acquiring record; no evidence of completion
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Ascension HealthIndustry (pharma, biotech, devices)
- Study start
- Mar 2011 (actual)
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Petroleum Jelly | Experimental | Biological: Petroleum JellyEvery patient will be applying petroleum jelly to the affected areas per protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Petroleum JellyAlso: Petrolatum, VaselineEvery 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. | Biological | Petroleum Jelly |
Primary outcome
Measuring the Effectiveness of Petroleum Jelly in Treating Nonscalp Seborrheic Dermatitis
Time frame: 4 weeks
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.
1 secondary outcome
Patient Satisfaction ofTreatment
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: PI Ryan D Stevenson left Organization (Genesys) prior to Ascension acquiring record; no evidence of completion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan D Stevenson, BS principal investigator
Ascension Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Petroleum Jelly in people with Seborrheic Dermatitis, run by Ascension Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI Ryan D Stevenson left Organization (Genesys) prior to Ascension acquiring record; no evidence of completion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the Effectiveness of Petroleum Jelly in Treating Nonscalp Seborrheic Dermatitis (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.