N/A
N=23
Treatment of Keratosis Pilaris With 810 nm Diode Laser
Keratosis Pilaris (KP)
Bottom Line
View on ClinicalTrials.gov: NCT01281644 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Difference in Disease Severity Scores — 4; 3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diode Laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Disease Severity Scores |
4; 3 | — |
| SECONDARY Patient Self-rated Severity |
4; 2.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01281644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.