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Dermatosis Papulosa Nigra (DPN)

Primary Purpose

Facial Dermatoses, Seborrheic Keratoses

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulsed dye laser
Curettage
Electrodesiccation
No treatment
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facial Dermatoses focused on measuring Dermatosis Papulosa Nigra, seborrheic keratoses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Davis Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Pulsed dye laser

Curettage

Electrodesiccation

No treatment

Arm Description

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.

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.

Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.

Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.

Outcomes

Primary Outcome Measures

Percent Clearance of All Lesions
The physician assessed percent clearance of all treated lesions and the control lesion.

Secondary Outcome Measures

Full Information

First Posted
July 2, 2008
Last Updated
April 6, 2015
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT00710203
Brief Title
Dermatosis Papulosa Nigra
Acronym
DPN
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Dermatoses, Seborrheic Keratoses
Keywords
Dermatosis Papulosa Nigra, seborrheic keratoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulsed dye laser
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Curettage
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Electrodesiccation
Arm Type
Active Comparator
Arm Description
Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
Arm Title
No treatment
Arm Type
Active Comparator
Arm Description
Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
Intervention Type
Device
Intervention Name(s)
Pulsed dye laser
Other Intervention Name(s)
The study will involve the use of Cynosure Cynergy 585 nm Pulsed Dye LASER.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Curettage
Intervention Description
A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
Intervention Type
Procedure
Intervention Name(s)
Electrodesiccation
Intervention Description
A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
Intervention Type
Other
Intervention Name(s)
No treatment
Intervention Description
A fourth lesion will not be treated and will serve as a control.
Primary Outcome Measure Information:
Title
Percent Clearance of All Lesions
Description
The physician assessed percent clearance of all treated lesions and the control lesion.
Time Frame
6 to 12 weeks
Other Pre-specified Outcome Measures:
Title
Evidence of Hypopigmentation
Description
The physician assessed evidence of hypopigmentation.
Time Frame
6 to 12 weeks
Title
Evidence of Hyperpigmentation
Description
The physician assessed evidence of hyperpigmentation.
Time Frame
6 to 12 weeks
Title
Evidence of Scar
Description
The physician assessed evidence of scar.
Time Frame
6 to 12 weeks
Title
Evidence of Texture Irregularities
Description
The physician assessed evidence of texture irregularities.
Time Frame
6 to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Eisen, M.D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ucdmc.ucdavis.edu/dermatology/research/clinical
Description
University of California-Davis Department of Dermatology Clinical Research

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Dermatosis Papulosa Nigra

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