Dermatosis Papulosa Nigra - Full Text View

Sponsor:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00710203

Purpose

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).

Condition	Intervention
Facial Dermatoses Seborrheic Keratoses	Device: pulsed dye laser (Cynosure Cynergy) Procedure: Curettage Procedure: Electrodesiccation

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Efficacy of a 585 nm PDL for the Treatment of Dermatosis Papulosa Nigra, and Compare it to Therapy With Curettage and Electrodesiccation.

Resource links provided by NLM:

MedlinePlus related topics: Skin Conditions

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	10
Study Start Date:	July 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: I 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.	Device: pulsed dye laser (Cynosure Cynergy) One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. Other Name: The study will involve the use of Cynosure Cynergy 585 nm Pulsed Dye LASER. Procedure: Curettage A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference. Procedure: Electrodesiccation A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.

Arms

Assigned Interventions

Experimental: I

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.

Device: pulsed dye laser (Cynosure Cynergy)

One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size.

Other Name: The study will involve the use of Cynosure Cynergy 585 nm Pulsed Dye LASER.

Procedure: Curettage

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

Procedure: Electrodesiccation

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710203

Locations

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

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

Daniel Eisen, M.D.

University of California, Davis

More Information

No publications provided

Responsible Party:	Dr. Daniel Eisen, M.D., University of California, Davis
ClinicalTrials.gov Identifier:	NCT00710203 History of Changes
Other Study ID Numbers:	200715981
Study First Received:	July 2, 2008
Last Updated:	May 7, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

Dermatosis Papulosa Nigra
seborrheic keratoses

Additional relevant MeSH terms:

Dermatitis, Seborrheic
Facial Dermatoses
Keratosis
Keratosis, Actinic
Keratosis, Seborrheic
Skin Diseases

Dermatitis
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012