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Trial record 12 of 14 for:    "Keratosis seborrheic"

Dermatosis Papulosa Nigra (DPN)

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ClinicalTrials.gov Identifier: NCT00710203
Recruitment Status : Completed
First Posted : July 4, 2008
Results First Posted : March 31, 2014
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Facial Dermatoses
Seborrheic Keratoses
Interventions Device: Pulsed dye laser
Procedure: Curettage
Procedure: Electrodesiccation
Other: No treatment
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Arm
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Study Arm
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  90.0%
>=65 years
1
  10.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
51.60  (12.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
8
  80.0%
Male
2
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Percent Clearance of All Lesions
Hide Description The physician assessed percent clearance of all treated lesions and the control lesion.
Time Frame 6 to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Dye Laser Curettage Electrodesiccation No Treatment
Hide Arm/Group Description:
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.
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.
Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
Overall Number of Participants Analyzed 10 10 10 10
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
10 10 10 10
Mean (Standard Deviation)
Unit of Measure: percentage of lesion clearance
88  (24.06) 96  (16.87) 92.5  (9.661) 0  (0)
2.Other Pre-specified Outcome
Title Evidence of Hypopigmentation
Hide Description The physician assessed evidence of hypopigmentation.
Time Frame 6 to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Dye Laser Curettage Electrodesiccation No Treatment
Hide Arm/Group Description:
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.
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.
Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
Overall Number of Participants Analyzed 10 10 10 10
Measure Type: Number
Unit of Measure: lesions
0 0 0 0
3.Other Pre-specified Outcome
Title Evidence of Hyperpigmentation
Hide Description The physician assessed evidence of hyperpigmentation.
Time Frame 6 to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Dye Laser Curettage Electrodesiccation No Treatment
Hide Arm/Group Description:
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.
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.
Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
Overall Number of Participants Analyzed 10 10 10 10
Measure Type: Number
Unit of Measure: lesions
4 4 5 0
4.Other Pre-specified Outcome
Title Evidence of Scar
Hide Description The physician assessed evidence of scar.
Time Frame 6 to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Dye Laser Curettage Electrodesiccation No Treatment
Hide Arm/Group Description:
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.
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.
Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
Overall Number of Participants Analyzed 10 10 10 10
Measure Type: Number
Unit of Measure: lesions
0 0 0 0
5.Other Pre-specified Outcome
Title Evidence of Texture Irregularities
Hide Description The physician assessed evidence of texture irregularities.
Time Frame 6 to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed Dye Laser Curettage Electrodesiccation No Treatment
Hide Arm/Group Description:
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.
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.
Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
Overall Number of Participants Analyzed 10 10 10 10
Measure Type: Number
Unit of Measure: lesions
1 0 1 3
Time Frame 6 months
Adverse Event Reporting Description No serious and/or other (non-serious) adverse events were observed.
 
Arm/Group Title Pulsed Dye Laser Curettage Electrodesiccation No Treatment
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Pulsed Dye Laser Curettage Electrodesiccation No Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pulsed Dye Laser Curettage Electrodesiccation No Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pulsed Dye Laser Curettage Electrodesiccation No Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Daniel Eisen, M.D.
Organization: UC Davis, Department of Dermatology
Phone: 916-734-6479
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00710203     History of Changes
Other Study ID Numbers: 200715981
First Submitted: July 2, 2008
First Posted: July 4, 2008
Results First Submitted: June 7, 2011
Results First Posted: March 31, 2014
Last Update Posted: April 28, 2015