Trial Outcomes & Findings for Treatment of Keratosis Pilaris With 810 nm Diode Laser (NCT NCT01281644)

Results Overview

The primary outcome measure was the difference in disease severity total score, combining redness and roughness/bumpiness scales, between the treated site and the control site, as rated by the blinded dermatologists at 12 weeks post-initial visit. These scales were not validated, as no relevant validated scale was available. However, raters were trained and calibrated on the use of the scale, and prior to review of study images, were asked to rate archival skin images on the same 4-point qualitative subscales used in the study. Each scale ranged from 0 to 3, with 0 being none and 3 being severe. The total score summed the redness and roughness/bumpiness scale scores for a range of 0 (none/better outcome) to 6 (severe/worse outcome).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-12-06

Participant Flow

The principal investigator selected patients presenting to the Dermatology Clinic at Northwestern Memorial Hospital who met the inclusion criteria. A brief, written description of the study was given to the patient.

Participant milestones

Participant milestones
Measure	Subjects Receiving Split Body Treatment The unit of randomization was the individual arm within each subject to receive either laser therapy on the right arm or on the left arm. Each subject received treatment using the 810 nm pulsed diode laser to the arm randomized to be the treatment site.
Overall Study STARTED	23
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Subjects Receiving Split Body Treatment The unit of randomization was the individual arm within each subject to receive either laser therapy on the right arm or on the left arm. Each subject received treatment using the 810 nm pulsed diode laser to the arm randomized to be the treatment site.
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Treatment of Keratosis Pilaris With 810 nm Diode Laser

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Receiving Split Body Treatment n=18 Participants The unit of randomization was the individual arm within each subject to receive either laser therapy on the right arm or on the left arm. Each subject received treatment using the 810 nm pulsed diode laser to the arm randomized to be the treatment site.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

The primary outcome measure was the difference in disease severity total score, combining redness and roughness/bumpiness scales, between the treated site and the control site, as rated by the blinded dermatologists at 12 weeks post-initial visit. These scales were not validated, as no relevant validated scale was available. However, raters were trained and calibrated on the use of the scale, and prior to review of study images, were asked to rate archival skin images on the same 4-point qualitative subscales used in the study. Each scale ranged from 0 to 3, with 0 being none and 3 being severe. The total score summed the redness and roughness/bumpiness scale scores for a range of 0 (none/better outcome) to 6 (severe/worse outcome).

Outcome measures

Outcome measures
Measure	No Laser Treatment n=18 Arm	45-60 J Diode Laser Therapy n=18 Arm Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms. Diode Laser: 810 nm diode laser
Difference in Disease Severity Scores	4 units on a scale Interval 3.0 to 5.0	3 units on a scale Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: 12 weeks

This outcome measure was the difference in disease severity total score, combining redness and roughness/bumpiness scales, between the treated site and the control site, as rated by the patient at 12 weeks post-initial visit. These scales were not validated, as no relevant validated scale was available. Each scale ranged from 0 to 3, with 0 being none and 3 being severe. The total score summed the redness and roughness/bumpiness scale scores for a range of 0 (none/better outcome) to 6 (severe/worse outcome).

Outcome measures

Outcome measures
Measure	No Laser Treatment n=18 arms	45-60 J Diode Laser Therapy n=18 arms Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms. Diode Laser: 810 nm diode laser
Patient Self-rated Severity	4 units on a scale Interval 3.0 to 4.0	2.5 units on a scale Interval 2.0 to 4.0

Adverse Events

No Laser Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

45-60 J Diode Laser Therapy

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	No Laser Treatment n=23 participants at risk	45-60 J Diode Laser Therapy n=23 participants at risk Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms. Diode Laser: 810 nm diode laser
Skin and subcutaneous tissue disorders post-inflammatory hyperpigmentation	0.00% 0/23 • 12 weeks	8.7% 2/23 • 12 weeks

Additional Information

Dr. Murad Alam

Northwestern University

Phone: 312-695-4761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place