Dermatosis Papulosa Nigra

Not Applicable

Completed

• Conditions: Seborrheic Keratoses; Facial Dermatoses
• Interventions: Procedure: Curettage; Device: Pulsed dye laser; Procedure: Electrodesiccation; Other: No treatment

• Registration Number: NCT00710203
• Lead Sponsor: University of California, Davis

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-04
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2011-06-07
• Results First Submitted QC: 2014-02-12
• Results First Posted: 2014-03-31
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Curettage	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.
Pulsed dye laser	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.
Electrodesiccation	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.
No treatment	No treatment	Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.

Primary Outcome Measures

Name	Time	Method
Percent Clearance of All Lesions	6 to 12 weeks	The physician assessed percent clearance of all treated lesions and the control lesion.

Trial Locations

Locations (1)

University of California, Davis Department of Dermatology; 🇺🇸 Sacramento, California, United States