Clinical Trial: Treatment of Keratosis Pilaris With 810 nm Diode Laser

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Keratosis Pilaris With 810 nm Diode Laser

Brief Summary: The investigators hope to establish whether or not the diode laser, a longer-wavelength laser, is effective in treating keratosis pilaris, and hopefully opening a door into the discussion and management of this skin condition. The primary outcome of interest is the difference in the overall blind rater severity scores of the treated versus the untreated sites. The secondary outcome of interest is the change in the patient's self-rated severity score of the treated site. To account for potential natural disease progression or regression, the investigators will also compare patient mean changes to the mean changes in severity scores of the untreated site.

Detailed Summary:
Sponsor: Northwestern University

Current Primary Outcome: Difference in Disease Severity Scores [ Time Frame: 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).


Original Primary Outcome: Difference in severity scores [ Time Frame: 4 wks ]

Difference in the overall blind rater severity scores of the treated versus the untreated sites


Current Secondary Outcome: Patient Self-rated Severity [ Time Frame: 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).


Original Secondary Outcome: Patient Self-rated Severity [ Time Frame: 4 wks ]

Change in the patient's self-rated severity score of the treated site.


Information By: Northwestern University

Dates:
Date Received: January 20, 2011
Date Started: March 2011
Date Completion:
Last Updated: October 15, 2014
Last Verified: October 2014