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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed dye laser | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Clearance of All Lesions | The physician assessed percent clearance of all treated lesions and the control lesion. | 6 to 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Evidence of Hypopigmentation | The physician assessed evidence of hypopigmentation. | 6 to 12 weeks |
| Evidence of Hyperpigmentation | The physician assessed evidence of hyperpigmentation. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Eisen, M.D. | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Department of Dermatology | Sacramento | California | 95816 | United States |
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| Label | URL |
|---|---|
| University of California-Davis Department of Dermatology Clinical Research | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Arm | 10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. 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. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Arm | 10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. 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. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Clearance of All Lesions | The physician assessed percent clearance of all treated lesions and the control lesion. | Posted | Mean | Standard Deviation | percentage of lesion clearance | 6 to 12 weeks | lesions | Participants |
|
6 months
No serious and/or other (non-serious) adverse events were observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pulsed Dye Laser | 10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Eisen, M.D. | UC Davis, Department of Dermatology | 916-734-6479 | dbeisen@ucdavis.edu |
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| ID | Term |
|---|---|
| D005148 | Facial Dermatoses |
| D017492 | Keratosis, Seborrheic |
| C562379 | Dermatosis Papulosa Nigra |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007642 | Keratosis |
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| ID | Term |
|---|---|
| D054025 | Lasers, Dye |
| D003475 | Curettage |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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|
| Curettage | Procedure | A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference. |
|
| Electrodesiccation | Procedure | A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. |
|
| No treatment | Other | A fourth lesion will not be treated and will serve as a control. |
|
| 6 to 12 weeks |
| Evidence of Scar | The physician assessed evidence of scar. | 6 to 12 weeks |
| Evidence of Texture Irregularities | The physician assessed evidence of texture irregularities. | 6 to 12 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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. |
| OG003 | No Treatment | Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control. |
|
|
| Other Pre-specified | Evidence of Hypopigmentation | The physician assessed evidence of hypopigmentation. | Posted | Number | lesions | 6 to 12 weeks |
|
|
|
| Other Pre-specified | Evidence of Hyperpigmentation | The physician assessed evidence of hyperpigmentation. | Posted | Number | lesions | 6 to 12 weeks |
|
|
|
| Other Pre-specified | Evidence of Scar | The physician assessed evidence of scar. | Posted | Number | lesions | 6 to 12 weeks |
|
|
|
| Other Pre-specified | Evidence of Texture Irregularities | The physician assessed evidence of texture irregularities. | Posted | Number | lesions | 6 to 12 weeks |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Curettage | 10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. 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. | 0 | 10 | 0 | 10 |
| EG002 | Electrodesiccation | 10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. | 0 | 10 | 0 | 10 |
| EG003 | No Treatment | 10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control. | 0 | 10 | 0 | 10 |
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| D013514 |
| Surgical Procedures, Operative |