An interventional study of Pulsed dye laser and Curettage in Facial Dermatoses and Seborrheic Keratoses, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-28.
Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment
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).
364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Pulsed dye laser
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.
Procedure: Curettage
Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
Procedure: Electrodesiccation
Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
Other: No 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.
Also known as: The study will involve the use of Cynosure Cynergy 585 nm Pulsed Dye LASER.
A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
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.
Percent Clearance of All Lesions
The physician assessed percent clearance of all treated lesions and the control lesion.
Time frame: 6 to 12 weeks
Evidence of Hypopigmentation
The physician assessed evidence of hypopigmentation.
Time frame: 6 to 12 weeks
Evidence of Hyperpigmentation
The physician assessed evidence of hyperpigmentation.
Time frame: 6 to 12 weeks
Evidence of Scar
The physician assessed evidence of scar.
Time frame: 6 to 12 weeks
Evidence of Texture Irregularities
The physician assessed evidence of texture irregularities.
Time frame: 6 to 12 weeks
| Milestone | Study Arm |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
The physician assessed percent clearance of all treated lesions and the control lesion.
| percentage of lesion clearance | Pulsed Dye Laser | Curettage | Electrodesiccation | No Treatment |
|---|---|---|---|---|
| Percent Clearance of All Lesions | 88 ± 24.06 | 96 ± 16.87 | 92.5 ± 9.661 | 0 ± 0 |
The physician assessed evidence of hypopigmentation.
| lesions | Pulsed Dye Laser | Curettage | Electrodesiccation | No Treatment |
|---|---|---|---|---|
| Evidence of Hypopigmentation | 0 | 0 | 0 | 0 |
The physician assessed evidence of hyperpigmentation.
| lesions | Pulsed Dye Laser | Curettage | Electrodesiccation | No Treatment |
|---|---|---|---|---|
| Evidence of Hyperpigmentation | 4 | 4 | 5 | 0 |
The physician assessed evidence of scar.
| lesions | Pulsed Dye Laser | Curettage | Electrodesiccation | No Treatment |
|---|---|---|---|---|
| Evidence of Scar | 0 | 0 | 0 | 0 |
The physician assessed evidence of texture irregularities.
| lesions | Pulsed Dye Laser | Curettage | Electrodesiccation | No Treatment |
|---|---|---|---|---|
| Evidence of Texture Irregularities | 1 | 0 | 1 | 3 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pulsed Dye Laser | — | 0/10 (0%) | 0/10 (0%) |
| Curettage | — | 0/10 (0%) | 0/10 (0%) |
| Electrodesiccation | — | 0/10 (0%) | 0/10 (0%) |
| No Treatment | — | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Study Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 1 |
| Age, Continuous(years) | Study Arm |
|---|---|
| Mean | 51.60 ± 12.62 |
| Sex: Female, Male(Participants) | Study Arm |
|---|---|
| Female | 8 |
| Male | 2 |
| Region of Enrollment(participants) | Study Arm |
|---|---|
| United States | 10 |
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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University of California, Davis