Study Results
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View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2008-07-31
2009-12-31
Brief Summary
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The purpose of this study is to determine the efficacy of a 585 nm PDL for the treatment of Dermatosis Papulosa Nigra, and compare it to therapy with curettage (scraping the lesions off) and electrodesiccation (burning the lesions off).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Pulsed dye laser
Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
Pulsed dye laser
One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
Curettage
Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
Curettage
A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
Electrodesiccation
Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
Electrodesiccation
A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
No treatment
Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
No treatment
A fourth lesion will not be treated and will serve as a control.
Interventions
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Pulsed dye laser
One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
Curettage
A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
Electrodesiccation
A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
No treatment
A fourth lesion will not be treated and will serve as a control.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to give informed consent.
* Desires removal of lesions.
* Willing to come back for six week follow-up.
* Willing to fill out post operative questionnaire.
* At least 4 lesions less than 7 mm.
* Diagnosis of Dermatosis Papulosa Nigra (DPN)
Exclusion Criteria
* Pregnant.
* Sensitive to laser energy.
* History of Collagen Vascular Disorders.
* History of Keloids.
* History of post inflammatory hyperpigmentation.
* Incarcerated.
* Unable to give informed consent.
* Unable to follow up for post operative evaluation.
* Unable to complete patient visual analogue scale.
* Unable to understand consent process or risks.
* Unable to accept risk of scar, infection, minor bleeding, permanent or prolonged hyperpigmentation and hypopigmentation.
18 Years
ALL
No
Sponsors
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University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Daniel Eisen, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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University of California, Davis Department of Dermatology
Sacramento, California, United States
Countries
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Related Links
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University of California-Davis Department of Dermatology Clinical Research
Other Identifiers
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200715981
Identifier Type: -
Identifier Source: org_study_id
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