Trial Outcomes & Findings for Dermatosis Papulosa Nigra (NCT NCT00710203)

NCT ID: NCT00710203

Last Updated: 2015-04-28

Results Overview

The physician assessed percent clearance of all treated lesions and the control lesion.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 6 to 12 weeks
• Results posted on: 2015-04-28

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dermatosis Papulosa Nigra

Baseline characteristics by cohort

Measure	Study Arm n=10 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	51.60 years STANDARD_DEVIATION 12.62 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 to 12 weeks

The physician assessed percent clearance of all treated lesions and the control lesion.

Outcome measures

Measure	Pulsed Dye Laser n=10 lesions 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 n=10 lesions 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 n=10 lesions 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 n=10 lesions Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
Percent Clearance of All Lesions	88 percentage of lesion clearance Standard Deviation 24.06	96 percentage of lesion clearance Standard Deviation 16.87	92.5 percentage of lesion clearance Standard Deviation 9.661	0 percentage of lesion clearance Standard Deviation 0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 to 12 weeks

The physician assessed evidence of hypopigmentation.

Outcome measures

Measure	Pulsed Dye Laser n=10 Participants 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 n=10 Participants 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 n=10 Participants 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 n=10 Participants Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
Evidence of Hypopigmentation	0 lesions	0 lesions	0 lesions	0 lesions

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 to 12 weeks

The physician assessed evidence of hyperpigmentation.

Outcome measures

Measure	Pulsed Dye Laser n=10 Participants 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 n=10 Participants 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 n=10 Participants 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 n=10 Participants Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
Evidence of Hyperpigmentation	4 lesions	4 lesions	5 lesions	0 lesions

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 to 12 weeks

The physician assessed evidence of scar.

Outcome measures

Measure	Pulsed Dye Laser n=10 Participants 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 n=10 Participants 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 n=10 Participants 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 n=10 Participants Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
Evidence of Scar	0 lesions	0 lesions	0 lesions	0 lesions

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 to 12 weeks

The physician assessed evidence of texture irregularities.

Outcome measures

Measure	Pulsed Dye Laser n=10 Participants 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 n=10 Participants 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 n=10 Participants 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 n=10 Participants Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
Evidence of Texture Irregularities	1 lesions	0 lesions	1 lesions	3 lesions

Adverse Events

Pulsed Dye Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Curettage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Electrodesiccation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Eisen, M.D.

UC Davis, Department of Dermatology

Phone: 916-734-6479

Email: dbeisen@ucdavis.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place