Trial Outcomes & Findings for A Device Study for the Treatment of Acne (NCT NCT04695691)

Results Overview

Primary effectiveness objective was to show more than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined as a subject with ≥50% fewer inflammatory acne lesions with respect to baseline

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

104 participants

Primary outcome timeframe

12 weeks post final treatment, up to 24 weeks

Results posted on

2023-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Laser Treatment Cutera Laser System: Subjects will receive laser treatments
Overall Study STARTED	104
Overall Study COMPLETED	76
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Device Study for the Treatment of Acne

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laser Treatment n=104 Participants Cutera Laser System: Subjects will receive laser treatments
Age, Continuous	22.2 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks post final treatment, up to 24 weeks

Primary effectiveness objective was to show more than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined as a subject with ≥50% fewer inflammatory acne lesions with respect to baseline

Outcome measures

Outcome measures
Measure	Laser Treatment n=104 Participants Cutera Laser System: Subjects will receive laser treatments
Percentage of Participants Achieving Treatment Success	81 Participants

Adverse Events

Laser Treatment

Serious events: 0 serious events

Other events: 104 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Laser Treatment n=104 participants at risk Cutera Laser System: Subjects will receive laser treatments
Skin and subcutaneous tissue disorders Erythema	100.0% 104/104 • 1 year post final treatment, up to approximately 18 months
Skin and subcutaneous tissue disorders Edema	98.1% 102/104 • 1 year post final treatment, up to approximately 18 months
Skin and subcutaneous tissue disorders Acne Purging	45.2% 47/104 • 1 year post final treatment, up to approximately 18 months
Skin and subcutaneous tissue disorders Dryness	18.3% 19/104 • 1 year post final treatment, up to approximately 18 months

Additional Information

Director Clinical Research

Cutera

Phone: 415-657-5518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place