Dermatosis Papulosa Nigra (DPN)

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.

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).

Study Overview

• Status: Completed
• Conditions: Facial Dermatoses; Seborrheic Keratoses
• Intervention / Treatment: Device: Pulsed dye laser; Procedure: Curettage; Procedure: Electrodesiccation; Other: No treatment

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • University of California, Davis Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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.; Other Names: The study will involve the use of Cynosure Cynergy 585 nm Pulsed Dye LASER.
Active Comparator: 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.	Procedure: Curettage; A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
Active Comparator: 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.	Procedure: Electrodesiccation; A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
Active Comparator: No treatment; 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; A fourth lesion will not be treated and will serve as a control.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of Hypopigmentation	The physician assessed evidence of hypopigmentation.	6 to 12 weeks
Evidence of Hyperpigmentation	The physician assessed evidence of hyperpigmentation.	6 to 12 weeks
Evidence of Scar	The physician assessed evidence of scar.	6 to 12 weeks
Evidence of Texture Irregularities	The physician assessed evidence of texture irregularities.	6 to 12 weeks

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

Helpful Links

• University of California-Davis Department of Dermatology Clinical Research

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: July 2, 2008
• First Submitted That Met QC Criteria: July 3, 2008
• First Posted (Estimate): July 4, 2008

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 6, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: seborrheic keratoses; Dermatosis Papulosa Nigra
• Additional Relevant MeSH Terms: Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Skin Diseases; Keratosis, Seborrheic; Facial Dermatoses
• Other Study ID Numbers: 200715981