Dermatosis Papulosa Nigra - Tabular View

Tracking Information

First Received Date ^ICMJE

July 2, 2008

Last Updated Date

May 7, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The physician will assess percent clearance of all treated lesions and the control lesion, evidence of hypo or hyper pigmentation, scar, keloid, and texture irregularities. [ Time Frame: 6 to 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00710203 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Dermatosis Papulosa Nigra

Official Title ^ICMJE

Efficacy of a 585 nm PDL for the Treatment of Dermatosis Papulosa Nigra, and Compare it to Therapy With Curettage and Electrodesiccation.

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Single Blind (Investigator), Single Group Assignment, Efficacy Study

Condition ^ICMJE

Facial Dermatoses
Seborrheic Keratoses

Intervention ^ICMJE

Device: pulsed dye laser (Cynosure Cynergy)
Procedure: Curettage
Procedure: Electrodesiccation

Study Arms / Comparison Groups

Experimental: 10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. 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. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2010

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00710203

Responsible Party

Dr. Daniel Eisen, M.D., University of California, Davis

Study ID Numbers ^ICMJE

200715981

Study Sponsor ^ICMJE

University of California, Davis

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Daniel Eisen, M.D.

University of California, Davis

Information Provided By

University of California, Davis

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP