Dermatosis Papulosa Nigra

Facial Dermatoses Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710203
• Other study ID #: 200715981
• Status: Completed
• Phase: N/A
• First received: July 2, 2008
• Last updated: April 6, 2015
• Start date: July 2008
• Est. completion date: December 2009

Study information

• Verified date: April 2015
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Dermatoses
• Keratosis
• Keratosis, Seborrheic
• Seborrheic Keratoses
• Skin Diseases
• Skin Diseases, Papulosquamous

Intervention

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.

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

Locations

Country	Name	City	State
United States	University of California, Davis Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evidence of Hypopigmentation	The physician assessed evidence of hypopigmentation.	6 to 12 weeks	No
Other	Evidence of Hyperpigmentation	The physician assessed evidence of hyperpigmentation.	6 to 12 weeks	No
Other	Evidence of Scar	The physician assessed evidence of scar.	6 to 12 weeks	No
Other	Evidence of Texture Irregularities	The physician assessed evidence of texture irregularities.	6 to 12 weeks	No
Primary	Percent Clearance of All Lesions	The physician assessed percent clearance of all treated lesions and the control lesion.	6 to 12 weeks	No

External Links

•   University of California-Davis Department of Dermatology Clinical Research