Trial Outcomes & Findings for Comparison of Electrodessication, Potassium Titanyl Phosphate (KTP) Laser and Pulsed Dye Laser for Treatment of Cherry Angiomata (NCT NCT00791908)

Results Overview

Each subject received all 3 treatments. Serial standardized photographs evaluated for color,texture and size by 2 blinded dermatologists using ordinal visual analog scales from 0 to 10(color: 0=skin colored, 5=red, 10=purple; texture: 0=flat, 5=mildly elevated, 10=elevated; size: 0=0mm, 10=10 mm).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2015-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Electrodessication, Potassium Titanyl Phosphate (KTP) Laser and Pulsed Dye Laser for Treatment of Cherry Angiomata

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects n=15 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	48 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Each subject received all 3 treatments. Serial standardized photographs evaluated for color,texture and size by 2 blinded dermatologists using ordinal visual analog scales from 0 to 10(color: 0=skin colored, 5=red, 10=purple; texture: 0=flat, 5=mildly elevated, 10=elevated; size: 0=0mm, 10=10 mm).

Outcome measures

Outcome measures
Measure	Electrodesiccation (ED) n=15 Participants Laser treatment applied to a third of the torso at each study visit.	KTP Laser n=15 Participants Laser treatment applied to a third of the torso at each study visit.	Pulsed-dye Laser (PDL) n=15 Participants Laser treatment applied to a third of the torso at each study visit.
Mean Changes in Color, Texture, and Size of Cherry Angiomata From Baseline to 3 Months After the Second Treatment by Treatment Type as Assessed by Blinded Raters Color of Cherry Angiomata	5.27 Units on a scale Interval 0.0 to 10.0	4.99 Units on a scale Interval 0.0 to 10.0	5.19 Units on a scale Interval 0.0 to 10.0
Mean Changes in Color, Texture, and Size of Cherry Angiomata From Baseline to 3 Months After the Second Treatment by Treatment Type as Assessed by Blinded Raters Texture of Cherry Angiomata	4.24 Units on a scale Interval 0.0 to 10.0	3.42 Units on a scale Interval 0.0 to 10.0	3.24 Units on a scale Interval 0.0 to 10.0
Mean Changes in Color, Texture, and Size of Cherry Angiomata From Baseline to 3 Months After the Second Treatment by Treatment Type as Assessed by Blinded Raters Size of Cherry Angiomata	3.40 Units on a scale Interval 0.0 to 10.0	3.44 Units on a scale Interval 0.0 to 10.0	3.31 Units on a scale Interval 0.0 to 10.0

Adverse Events

Electrodesiccation (ED)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

KTP Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pulsed-dye Laser (PDL)

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

Murad Alam, MD

Northwestern University

Phone: 312-695-6785

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place