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Trial record 12 of 14 for:    "Keratosis seborrheic"

Dermatosis Papulosa Nigra (DPN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 2, 2008
First Posted Date  ICMJE July 4, 2008
Results First Submitted Date  ICMJE June 7, 2011
Results First Posted Date  ICMJE March 31, 2014
Last Update Posted Date April 28, 2015
Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
Percent Clearance of All Lesions [ Time Frame: 6 to 12 weeks ]
The physician assessed percent clearance of all treated lesions and the control lesion.
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2008)
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 ]
Change History Complete list of historical versions of study NCT00710203 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: February 12, 2014)
  • Evidence of Hypopigmentation [ Time Frame: 6 to 12 weeks ]
    The physician assessed evidence of hypopigmentation.
  • Evidence of Hyperpigmentation [ Time Frame: 6 to 12 weeks ]
    The physician assessed evidence of hyperpigmentation.
  • Evidence of Scar [ Time Frame: 6 to 12 weeks ]
    The physician assessed evidence of scar.
  • Evidence of Texture Irregularities [ Time Frame: 6 to 12 weeks ]
    The physician assessed evidence of texture irregularities.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dermatosis Papulosa Nigra
Official Title  ICMJE 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.
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Facial Dermatoses
  • Seborrheic Keratoses
Intervention  ICMJE
  • 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.
  • 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.
  • Other: No treatment
    A fourth lesion will not be treated and will serve as a control.
Study Arms  ICMJE
  • 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.
    Intervention: Device: 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.
    Intervention: Procedure: Curettage
  • 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.
    Intervention: Procedure: Electrodesiccation
  • 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.
    Intervention: Other: No treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2008)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00710203
Other Study ID Numbers  ICMJE 200715981
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Eisen, M.D. University of California, Davis
PRS Account University of California, Davis
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP