Dermatosis Papulosa Nigra (DPN)

University of California (UC) Davis

Status: Completed

Conditions: Seborrheic Keratoses; Facial Dermatoses

Treatments: Other: No treatment; Procedure: Curettage; Device: Pulsed dye laser; Procedure: Electrodesiccation

Study type: Interventional

Funder types: Other

Identifiers

NCT00710203

200715981

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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10 participants in 4 patient groups

Pulsed dye laser

Active Comparator group

Description:

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.

Treatment:

Device: Pulsed dye laser

Curettage

Active Comparator group

Description:

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.

Treatment:

Procedure: Curettage

Electrodesiccation

Active Comparator group

Description:

Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.

Treatment:

Procedure: Electrodesiccation

No treatment

Active Comparator group

Description:

Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.

Treatment:

Other: No treatment