Facial DermatosesDPNNCT00710203
Dermatosis Papulosa Nigra
A study testing Pulsed dye laser, Curettage and Electrodesiccation in people with Facial Dermatoses and Seborrheic Keratoses, run by University of California, Davis at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Dermatoses, Seborrheic Keratoses
- What is being tested?
- Pulsed dye laser, Curettage and Electrodesiccation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Less than 18 years of age.
- Pregnant.
- Sensitive to laser energy.
- History of Collagen Vascular Disorders.
- History of Keloids.
- History of post inflammatory hyperpigmentation.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Department of Dermatology
Sacramento, California, 95816
About this study
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.
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).
- Conditions
- Facial Dermatoses, Seborrheic Keratoses
- Being tested
- Pulsed dye laser, Curettage, Electrodesiccation, No treatment
- Keywords
- Dermatosis Papulosa Nigra, seborrheic keratoses
- Medical subject headings
- Facial Dermatoses, Keratosis, Seborrheic, Dermatosis Papulosa Nigra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed dye laserDevice
Also called The study will involve the use of Cynosure Cynergy 585 nm 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.
CurettageProcedure or surgery
A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
ElectrodesiccationProcedure or surgery
A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
No treatmentOther
A fourth lesion will not be treated and will serve as a control.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed dye laser | Active comparator | 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. Receives: Device: Pulsed dye laser |
| Curettage | Active comparator | 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. Receives: Procedure: Curettage |
| Electrodesiccation | Active comparator | Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. Receives: Procedure: Electrodesiccation |
| No treatment | Active comparator | Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control. Receives: Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Clearance of All Lesions
The physician assessed percent clearance of all treated lesions and the control lesion.
Measured: 6 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Facial DermatosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Eisen, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710203
- Sponsor's protocol ID
- 200715981
- Acronym
- DPN
- Status last verified
- Apr 2015
- First submitted
- 2 Jul 2008
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00710203
- Acronym / sponsor ID
- DPN / 200715981
- Conditions
- Facial Dermatoses, Seborrheic Keratoses
- Keywords
- Dermatosis Papulosa Nigra, seborrheic keratoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Jul 2008 (estimated)
- Results
- Posted 31 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pulsed dye laser | Active comparator | Device: Pulsed dye laserFour 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. |
| Curettage | Active comparator | Procedure: CurettageFour 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. |
| Electrodesiccation | Active comparator | Procedure: ElectrodesiccationFour lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. |
| No treatment | Active comparator | Other: No treatmentFour lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- Less than 18 years of age.
- Pregnant.
- Sensitive to laser energy.
- History of Collagen Vascular Disorders.
- History of Keloids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed dye laserAlso: The study will involve the use of Cynosure Cynergy 585 nm 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. | Device | Pulsed dye laser |
| CurettageA second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference. | Procedure or surgery | Curettage |
| ElectrodesiccationA third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. | Procedure or surgery | Electrodesiccation |
| No treatmentA fourth lesion will not be treated and will serve as a control. | Other | No treatment |
Primary outcome
Percent Clearance of All Lesions
Time frame: 6 to 12 weeks
The physician assessed percent clearance of all treated lesions and the control lesion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Eisen, M.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed dye laser, Curettage and Electrodesiccation in people with Facial Dermatoses and Seborrheic Keratoses, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Clearance of All Lesions (time frame: 6 to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015; AzTrials last refreshed its copy on 30 Oct 2026.