Dermatosis Papulosa Nigra (DPN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00710203
First received: July 2, 2008
Last updated: May 16, 2014
Last verified: May 2014
  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
Procedure: Curettage
Procedure: Electrodesiccation
Other: No treatment

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 Pulsed Dye Laser (PDL) for the Treatment of Dermatosis Papulosa Nigra, and Compare it to Therapy With Curettage and Electrodesiccation.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percent Clearance of All Lesions [ Time Frame: 6 to 12 weeks ] [ Designated as safety issue: No ]
    The physician assessed percent clearance of all treated lesions and the control lesion.


Other Outcome Measures:
  • Evidence of Hypopigmentation [ Time Frame: 6 to 12 weeks ] [ Designated as safety issue: No ]
    The physician assessed evidence of hypopigmentation.

  • Evidence of Hyperpigmentation [ Time Frame: 6 to 12 weeks ] [ Designated as safety issue: No ]
    The physician assessed evidence of hyperpigmentation.

  • Evidence of Scar [ Time Frame: 6 to 12 weeks ] [ Designated as safety issue: No ]
    The physician assessed evidence of scar.

  • Evidence of Texture Irregularities [ Time Frame: 6 to 12 weeks ] [ Designated as safety issue: No ]
    The physician assessed evidence of texture irregularities.


Enrollment: 10
Study Start Date: July 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: University of California, Davis
ClinicalTrials.gov Identifier: NCT00710203     History of Changes
Other Study ID Numbers: 200715981
Study First Received: July 2, 2008
Results First Received: June 7, 2011
Last Updated: May 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Dermatosis Papulosa Nigra
seborrheic keratoses

Additional relevant MeSH terms:
Facial Dermatoses
Keratosis
Keratosis, Seborrheic
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on October 21, 2014