Trial Outcomes & Findings for Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea (NCT NCT02268474)

Results Overview

Measured for each treatment arm based on blinded physician assessment of subject photographs using the Physician's Global Assessment Scale (min=0; max=4) Higher scores mean better improvement 0 = 0% Improvement (None) 1. = \< 25% Improvement (Mild) 2. = 26 to 50% Improvement (Moderate) 3. = 51 to 75% Improvement (Significant) 4. = 76 to 100% Improvement (Very Significant)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

6 weeks

Results posted on

2023-02-21

Participant Flow

Unit of analysis: sides of the face

Participant milestones

Participant milestones
Measure	All Study Participants Subjects will be treated with the Excel V 532nm (KTP) Laser and the 595nm Pulse Dye Laser: One half of the face will be treated with the 532nm KTP laser and the other half of the face will be treated with the 595nm Pulse Dye Laser.
Overall Study STARTED	22 44
Overall Study Treatment With the 532nm KTP Laser	22 22
Overall Study Treatment With the 595nm Pulse Dye Laser	22 22
Overall Study COMPLETED	19 38
Overall Study NOT COMPLETED	3 6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Subjects n=22 Participants Cutera® Excel V Excel V 532nm (KTP) Laser or 595nm Pulse Dye Laser: Each subject's face will be divided in half and labeled as A (Right Side of the Face) or B (Left Side of Face). The allocation of treatment (532nm KTP laser) and active control treatment (595nm PDL) arms will be determined by randomization.
Age, Continuous	50.1 years STANDARD_DEVIATION 10.3 • n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Region of Enrollment United States	22 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 weeks

Measured for each treatment arm based on blinded physician assessment of subject photographs using the Physician's Global Assessment Scale (min=0; max=4) Higher scores mean better improvement 0 = 0% Improvement (None) 1. = \< 25% Improvement (Mild) 2. = 26 to 50% Improvement (Moderate) 3. = 51 to 75% Improvement (Significant) 4. = 76 to 100% Improvement (Very Significant)

Outcome measures

Outcome measures
Measure	532nm KTP Laser n=19 Participants Excel V 532nm (KTP) Laser on one side of the face	595nm Pulse Dye Laser n=19 Participants 595nm Pulse Dye Laser on one side of the face
Degree of Improvement in Erythematotelangiectatic Rosacea and Papulopustular Rosacea	2.114 score on a scale Standard Deviation 1.5125	2.088 score on a scale Standard Deviation 1.681

Adverse Events

532nm KTP Laser

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

595nm Pulse Dye Laser

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	532nm KTP Laser n=22 participants at risk Cutera® Excel V Excel V 532nm (KTP) Laser or 595nm Pulse Dye Laser: Each subject's face will be divided in half and labeled as A (Right Side of the Face) or B (Left Side of Face). The allocation of treatment (532nm KTP laser) and active control treatment (595nm PDL) arms will be determined by randomization.	595nm Pulse Dye Laser n=22 participants at risk 595nm Pulse Dye Laser Excel V 532nm (KTP) Laser or 595nm Pulse Dye Laser: Each subject's face will be divided in half and labeled as A (Right Side of the Face) or B (Left Side of Face). The allocation of treatment (532nm KTP laser) and active control treatment (595nm PDL) arms will be determined by randomization.
Skin and subcutaneous tissue disorders Erythema	100.0% 22/22 • 6 weeks	100.0% 22/22 • 6 weeks
Skin and subcutaneous tissue disorders Edema	100.0% 22/22 • 6 weeks	100.0% 22/22 • 6 weeks

Additional Information

Margot Doucette

Cutera

Phone: 415-657-5518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place