Trial Outcomes & Findings for Safety and Efficacy of the Luxe Device to Treat Facial Wrinkles and Rosacea (NCT NCT01618864)

Results Overview

Data reported as percentage of participants showing improvement in overall score as assessed by investigator. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement)provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

4, 8 weeks

Results posted on

2014-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	Luxe Treatment Group Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
Overall Study STARTED	23
Overall Study Completed 2 Weeks	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Luxe Treatment Group Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	2

Baseline Characteristics

Safety and Efficacy of the Luxe Device to Treat Facial Wrinkles and Rosacea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Luxe Treatment Group n=23 Participants Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 4, 8 weeks

Data reported as percentage of participants showing improvement in overall score as assessed by investigator. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement)provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage.

Outcome measures

Outcome measures
Measure	Luxe Treatment Group at 4 Weeks n=19 Participants Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.	Luxe Treatment Group at 8 Weeks n=19 Participants GAI assessment by investigator at 8 weeks.
Improvement in Investigator Assessment of Overall Global Aesthetic Improvement Scale (GAI)	61 percentage of participants	68 percentage of participants

SECONDARY outcome

Timeframe: 4, 8 weeks

Data reported as percentage of participants showing improvement in overall score as assessed by subject. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement) provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage. Analogous to Outcome Measure 1.

Outcome measures

Outcome measures
Measure	Luxe Treatment Group at 4 Weeks n=19 Participants Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.	Luxe Treatment Group at 8 Weeks n=19 Participants GAI assessment by investigator at 8 weeks.
Subject Improvement Using the Global Aesthetic Improvement (GAI) Scale	68 percentage of participants	68 percentage of participants

SECONDARY outcome

Timeframe: 4, 8 weeks

Population: Not all subjects had rosacea. 11 subjects evaluated at baseline and 4 weeks; 9 subjects evaluated at 8 weeks, since 2 subjects lost to follow-up.

Data reported as percentage of participants showing improvement in rosacea scale: 4 point scale for presence of rosacea features from 0 (absent) to 3 (severe) for: flushing, nontransient erythema, papules and pustules and telangiectasia.

Outcome measures

Outcome measures
Measure	Luxe Treatment Group at 4 Weeks n=11 Participants Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.	Luxe Treatment Group at 8 Weeks n=9 Participants GAI assessment by investigator at 8 weeks.
Reduction in Rosacea by the Study Investigator Using a Validated Scale	64 percentage of participants	89 percentage of participants

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Group n=23 participants at risk All treated subjects were evaluated for adverse events during the study.
Skin and subcutaneous tissue disorders Acne	8.7% 2/23 • Number of events 2 • Adverse event data collected during 8 weeks of treatment.

Additional Information

Director of Clinical Affairs

Iluminage

Phone: +972 547 800 260

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right to remove all Confidential Information from any publications or presentations to protect its intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER