Dermatosis Papulosa Nigra

NCT ID: NCT00710203

Last Updated: 2015-04-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Facial Dermatoses Seborrheic Keratoses

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Pulsed dye laser

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Curettage

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Electrodesiccation

Intervention Type PROCEDURE

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

No treatment

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

Group Type ACTIVE_COMPARATOR

No treatment

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

Curettage

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

Intervention Type PROCEDURE

Electrodesiccation

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

Intervention Type PROCEDURE

No treatment

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

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Eisen, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California, Davis Department of Dermatology

Sacramento, California, United States

Site Status

Countries

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United States

Related Links

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http://www.ucdmc.ucdavis.edu/dermatology/research/clinical

University of California-Davis Department of Dermatology Clinical Research

Other Identifiers

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200715981

Identifier Type: -

Identifier Source: org_study_id

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