Skip to main content
OpenTrials
Completed

NCT Number: NCT00710203

Dermatosis Papulosa Nigra

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Facial Dermatoses Dermatosis Papulosa Nigra Keratosis Keratosis, Seborrheic Seborrheic Keratoses Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis Department of Dermatology

Sacramento, California, 95816, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Curettage

Procedure

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

Electrodesiccation

Procedure

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

No treatment

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study 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.

Acronym: DPN

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 4, 2008
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.