Keratosis Pilaris (KP) Clinical Trial
— KPOfficial title:
Treatment of Keratosis Pilaris With 810 nm Diode Laser
| NCT number | NCT01281644 |
| Other study ID # | MA111810 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2011 |
| Est. completion date | October 2011 |
| Verified date | December 2021 |
| Source | Northwestern University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Northwestern University | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Northwestern University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference in Disease Severity Scores | 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). | 12 weeks | |
| Secondary | Patient Self-rated Severity | 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). | 12 weeks |