Trial Outcomes & Findings for Pulsed Dye Laser and Affirm Laser in the Treatment of Abdominoplasty Scars (NCT NCT00735254)

NCT ID: NCT00735254

Last Updated: 2018-02-08

Results Overview

The purpose of this study is to determine the efficacy of the 585-nm pulsed dye laser (PDL) and 1440-nm Affirm laser in the treatment of surgical scars starting one week after closure of transverse abdominal incision.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 3 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2018-02-08

Participant Flow

Participant milestones

Measure	Pulsed Dye Laser PDL Patient will be have scar treated with pulsed dye laser. pulsed dye laser: patient will have scar treated with pulsed dye laser	Affirm Laser Patient will be have scar treated with Affirm Laser Affirm Laser: patient will have scar treated with Affirm laser	Combined PDL and Affirm Lasers Patient will be have scar treated with combined Affirm + PDL combined PDL and Affirm Lasers: patient will have scar treated with Affirm and pulsed dye lasers	Placebo Patient will be have scar treated with Placebo Placebo: patient will receive no treatment
Overall Study STARTED	1	1	1	0
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	1	1	1	0

Reasons for withdrawal

Measure	Pulsed Dye Laser PDL Patient will be have scar treated with pulsed dye laser. pulsed dye laser: patient will have scar treated with pulsed dye laser	Affirm Laser Patient will be have scar treated with Affirm Laser Affirm Laser: patient will have scar treated with Affirm laser	Combined PDL and Affirm Lasers Patient will be have scar treated with combined Affirm + PDL combined PDL and Affirm Lasers: patient will have scar treated with Affirm and pulsed dye lasers	Placebo Patient will be have scar treated with Placebo Placebo: patient will receive no treatment
Overall Study Protocol Violation	1	1	1	0

Baseline Characteristics

PI left institution, no data available.

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 1 year

Population: study was not conducted per protocol, data was not collected, study terminated. Reported to IRB and closed study.

The purpose of this study is to determine the efficacy of the 585-nm pulsed dye laser (PDL) and 1440-nm Affirm laser in the treatment of surgical scars starting one week after closure of transverse abdominal incision.

Outcome measures

Outcome data not reported

Adverse Events

Pulsed Dye Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Affirm Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combined PDL and Affirm Lasers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Edward Galiczynski, MD

Arizona Dermatology and Cosmetic

Phone: (602) 277-1449

Email: egaliczynski@arizonaderm.com

Results disclosure agreements

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