Dermatosis Papulosa Nigra

Study Overview
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Brief Summary
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DPN is a disorder among darkly pigmented patients, manifested by small, benign, variants of seborrheic keratoses, predominantly on the face. 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).

Official Title
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Efficacy of a 585 nm Pulsed Dye Laser (PDL) for the Treatment of Dermatosis Papulosa Nigra, and Compare it to Therapy With Curettage and Electrodesiccation.

Conditions
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Facial Dermatoses, Seborrheic Keratoses

Intervention / Treatment
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* Device: Pulsed dye laser
* Procedure: Curettage
* Procedure: Electrodesiccation
* Other: No treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years of age. 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: Less than 18 years of age. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulsed dye laser<br>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. | Device: Pulsed dye laser<br>* 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.<br>* Other names: The study will involve the use of Cynosure Cynergy 585 nm Pulsed Dye LASER.;|
| Active Comparator: Curettage<br>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. | Procedure: Curettage<br>* A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.<br>|
| Active Comparator: Electrodesiccation<br>Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. | Procedure: Electrodesiccation<br>* A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.<br>|
| Active Comparator: No treatment<br>Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control. | Other: No treatment<br>* A fourth lesion will not be treated and will serve as a control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Clearance of All Lesions | The physician assessed percent clearance of all treated lesions and the control lesion. | 6 to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatosis Papulosa Nigra, seborrheic keratoses