Dermatosis Papulosa Nigra

NCT00710203 | Completed Results

• 1 other identifier: 200715981
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Facial Dermatoses; Seborrheic Keratoses

Keywords

Dermatosis Papulosa Nigra; seborrheic keratoses

Outcome Measures

Primary Outcomes (1)

• Percent Clearance of All Lesions

  The physician assessed percent clearance of all treated lesions and the control lesion.

  6 to 12 weeks

Other Outcomes (4)

• Evidence of Hypopigmentation

  6 to 12 weeks

• Evidence of Hyperpigmentation

  6 to 12 weeks

• Evidence of Scar

  6 to 12 weeks

Study Arms (4)

Pulsed dye laser

ACTIVE COMPARATOR

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

Curettage

ACTIVE COMPARATOR

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

Electrodesiccation

ACTIVE COMPARATOR

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

No treatment

ACTIVE COMPARATOR

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

Interventions

Pulsed dye laser DEVICE

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.

Also known as: The study will involve the use of Cynosure Cynergy 585 nm Pulsed Dye LASER.

Pulsed dye laser

Curettage PROCEDURE

A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.

Curettage

Electrodesiccation PROCEDURE

A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.

Electrodesiccation

No treatment OTHER

A fourth lesion will not be treated and will serve as a control.

No treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Links

• University of California-Davis Department of Dermatology Clinical Research

MeSH Terms

Conditions

Facial Dermatoses; Keratosis, Seborrheic; Dermatosis Papulosa Nigra

Interventions

Lasers, Dye; Curettage

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Keratosis

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Surgical Procedures, Operative

Results Point of Contact

• Title: Daniel Eisen, M.D.
• Organization: UC Davis, Department of Dermatology

dbeisen@ucdavis.edu

916-734-6479

Study Officials

• Daniel Eisen, M.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 28, 2015
• Results First Posted: March 31, 2014

Record last verified: 2015-04

Locations

US (1)