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Dermatosis Papulosa Nigra (DPN)

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ClinicalTrials.gov Identifier: NCT00710203
Recruitment Status : Completed
First Posted : July 4, 2008
Results First Posted : March 31, 2014
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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).


Condition or disease Intervention/treatment Phase
Facial Dermatoses Seborrheic Keratoses Device: Pulsed dye laser Procedure: Curettage Procedure: Electrodesiccation Other: No treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (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.
Study Start Date : July 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions
U.S. FDA Resources

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 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.



Primary Outcome Measures :
  1. Percent Clearance of All Lesions [ Time Frame: 6 to 12 weeks ]
    The physician assessed percent clearance of all treated lesions and the control lesion.


Other Outcome Measures:
  1. Evidence of Hypopigmentation [ Time Frame: 6 to 12 weeks ]
    The physician assessed evidence of hypopigmentation.

  2. Evidence of Hyperpigmentation [ Time Frame: 6 to 12 weeks ]
    The physician assessed evidence of hyperpigmentation.

  3. Evidence of Scar [ Time Frame: 6 to 12 weeks ]
    The physician assessed evidence of scar.

  4. Evidence of Texture Irregularities [ Time Frame: 6 to 12 weeks ]
    The physician assessed evidence of texture irregularities.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00710203     History of Changes
Other Study ID Numbers: 200715981
First Posted: July 4, 2008    Key Record Dates
Results First Posted: March 31, 2014
Last Update Posted: April 28, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Keratosis, Seborrheic
Skin Diseases, Papulosquamous
Facial Dermatoses
Precancerous Conditions
Neoplasms