Facial Dermatoses, Seborrheic Keratoses
Conditions
Keywords
Dermatosis Papulosa Nigra, seborrheic keratoses
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).
Interventions
DEVICEPulsed 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.
PROCEDURECurettage
A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
PROCEDUREElectrodesiccation
A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
OTHERNo treatment
A fourth lesion will not be treated and will serve as a control.
Sponsors
University of California, Davis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Clearance of All Lesions | 6 to 12 weeks | The physician assessed percent clearance of all treated lesions and the control lesion. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Hypopigmentation | 6 to 12 weeks | The physician assessed evidence of hypopigmentation. |
| Evidence of Hyperpigmentation | 6 to 12 weeks | The physician assessed evidence of hyperpigmentation. |
| Evidence of Scar | 6 to 12 weeks | The physician assessed evidence of scar. |
| Evidence of Texture Irregularities | 6 to 12 weeks | The physician assessed evidence of texture irregularities. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Study Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 51.60 years STANDARD_DEVIATION 12.62 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Percent Clearance of All Lesions
The physician assessed percent clearance of all treated lesions and the control lesion.
Time frame: 6 to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulsed Dye Laser | Percent Clearance of All Lesions | 88 percentage of lesion clearance | Standard Deviation 24.06 |
| Curettage | Percent Clearance of All Lesions | 96 percentage of lesion clearance | Standard Deviation 16.87 |
| Electrodesiccation | Percent Clearance of All Lesions | 92.5 percentage of lesion clearance | Standard Deviation 9.661 |
| No Treatment | Percent Clearance of All Lesions | 0 percentage of lesion clearance | Standard Deviation 0 |
Other Pre-specified
Evidence of Hyperpigmentation
The physician assessed evidence of hyperpigmentation.
Time frame: 6 to 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsed Dye Laser | Evidence of Hyperpigmentation | 4 lesions |
| Curettage | Evidence of Hyperpigmentation | 4 lesions |
| Electrodesiccation | Evidence of Hyperpigmentation | 5 lesions |
| No Treatment | Evidence of Hyperpigmentation | 0 lesions |
Other Pre-specified
Evidence of Hypopigmentation
The physician assessed evidence of hypopigmentation.
Time frame: 6 to 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsed Dye Laser | Evidence of Hypopigmentation | 0 lesions |
| Curettage | Evidence of Hypopigmentation | 0 lesions |
| Electrodesiccation | Evidence of Hypopigmentation | 0 lesions |
| No Treatment | Evidence of Hypopigmentation | 0 lesions |
Other Pre-specified
Evidence of Scar
The physician assessed evidence of scar.
Time frame: 6 to 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsed Dye Laser | Evidence of Scar | 0 lesions |
| Curettage | Evidence of Scar | 0 lesions |
| Electrodesiccation | Evidence of Scar | 0 lesions |
| No Treatment | Evidence of Scar | 0 lesions |
Other Pre-specified
Evidence of Texture Irregularities
The physician assessed evidence of texture irregularities.
Time frame: 6 to 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulsed Dye Laser | Evidence of Texture Irregularities | 1 lesions |
| Curettage | Evidence of Texture Irregularities | 0 lesions |
| Electrodesiccation | Evidence of Texture Irregularities | 1 lesions |
| No Treatment | Evidence of Texture Irregularities | 3 lesions |