Treatment of Keratosis Pilaris With 810 nm Diode Laser

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Subject is age 18 to 65
Subject has diagnosis of keratosis pilaris involving both arms
Subject has Fitzpatrick Skin Type I - III
Subject is in good health
Subject has the willingness and ability to understand and provide informed consen

Exclusion Criteria

Under 18 or over 65 years of age
Subjects with Fitzpatrick Skin Type greater than III
Subjects who have received any laser therapy to the armsin the past year
Subjects with concurrent diagnosis of another skin condition or malignancy
Subjects with tan or sunburn over the upper arms in the past month
Subjects with open, non-healing sores or infections at any skin site
Subjects who are unable to understand the protocol or give informed consent
Subjects who take oral photosensitizing medications or who apply topical photosensitizing medications to either arm

Arm && Interventions

Group	Intervention	Description
45-60 J Diode Laser Therapy	Diode Laser	Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.

Primary Outcome Measures

Name	Time	Method
Difference in Disease Severity Scores	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).

Secondary Outcome Measures

Name	Time	Method
Patient Self-rated Severity	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).

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial