Trial Outcomes & Findings for Study of the Use of Low Level Laser Therapy to Reduce Acne (NCT NCT01276535)

Results Overview

The Burton et al. Acne Severity Grade Scale grades the type of acne lesion from Grade 0: no acne lesions through Grade 1: sub-clinical acne, Grade 2: mild acne, Grade 3: moderate acne; Grade 4: severe acne, to Grade 5: extremely severe acne. The number of participants whose entire face demonstrated an improvement of one or more grades on the Burton et al. Acne Severity Scale at week 6 relative to baseline was calculated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

baseline and 6 weeks

Results posted on

2015-12-11

Participant Flow

12 subjects were recruited and enrolled from March 2, 2010 through April 29, 2010 at one medical clinic.

There were no significant events or approaches for the overall study following participant enrollment, but prior to group assignment. There were no enrolled participants excluded from the trial before assignment to groups.

Participant milestones

Participant milestones
Measure	Erchonia MLS & Erchonia THL The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator. The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Use of Low Level Laser Therapy to Reduce Acne

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erchonia MLS & Erchonia THL n=12 Participants The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator. The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject.
Age, Continuous	29.5 years STANDARD_DEVIATION 5.98 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 weeks

The Burton et al. Acne Severity Grade Scale grades the type of acne lesion from Grade 0: no acne lesions through Grade 1: sub-clinical acne, Grade 2: mild acne, Grade 3: moderate acne; Grade 4: severe acne, to Grade 5: extremely severe acne. The number of participants whose entire face demonstrated an improvement of one or more grades on the Burton et al. Acne Severity Scale at week 6 relative to baseline was calculated.

Outcome measures

Outcome measures
Measure	Erchonia MLS & Erchonia THL n=12 Participants The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator. The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject.
Grade on the Burton et al. Acne Severity Grade Scale	2 participants

SECONDARY outcome

Timeframe: Baseline and 6 weeks

The number of pustules, papules and nodules are summed to attain a total inflammatory lesion count.

Outcome measures

Outcome measures
Measure	Erchonia MLS & Erchonia THL n=10 Participants The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator. The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject.
Change From Baseline in Inflammatory Lesion Count at 6 Weeks	-9.75 lesions Standard Deviation 4.56

SECONDARY outcome

Timeframe: Baseline and 6 weeks

The number of open comedones and closed comedones are summed to attain the total non-inflammatory lesion count.

Outcome measures

Outcome measures
Measure	Erchonia MLS & Erchonia THL n=12 Participants The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator. The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject.
Change From Baseline in Non-Inflammatory Lesion Count at 6 Weeks	-77.00 lesions Standard Deviation 21.78

Adverse Events

Erchonia MLS & Erchonia THL

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

Gregory A. Nikolaidis, MD

Westlake Dermatology

Phone: 512-328-3376

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place