| Registry | NCT01281644, acronym KP |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: single, treatment |
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| Enrollment | 23 (Actual) |
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| Sponsor | Northwestern University (Other) |
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| Conditions | Keratosis Pilaris (KP) |
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| Interventions | Diode Laser (Device) |
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| Dates | start 2011-03-01, primary completion 2011-10-01, completion 2011-10-01, first posted 2011-01-24, last updated 2021-12-06 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Keratosis Pilaris (KP) All trials of Diode Laser
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| No Laser Treatment | No intervention | | |
| 45-60 J Diode Laser Therapy | Active comparator | Device: Diode Laser | Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms. |
- Diode Laser (Device): 810 nm diode laser
+Outcome measures
Primary outcomes
- 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 outcomes
- 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).
+Eligibility
Sex: All, ages: 18 Years to 65 Years
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
+Posted results
Participant flow
| Milestone | Subjects Receiving Split Body Treatment |
|---|
| Started | 23 |
| Completed | 18 |
| Not completed | 5 |
Outcome results
- Difference in Disease Severity Scores (Primary), Median, units on a scale: No Laser Treatment 4 (3 to 5); 45-60 J Diode Laser Therapy 3 (2 to 4)
- Patient Self-rated Severity (Secondary), Median, units on a scale: No Laser Treatment 4 (3 to 4); 45-60 J Diode Laser Therapy 2.5 (2 to 4)
Adverse events
Time frame: 12 weeks
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| No Laser Treatment | 0 | 0/23 (0.0%) | 0/23 (0.0%) |
| 45-60 J Diode Laser Therapy | 0 | 0/23 (0.0%) | 2/23 (8.7%) |
Other adverse events by term
| Term | Organ system | No Laser Treatment | 45-60 J Diode Laser Therapy |
|---|
| post-inflammatory hyperpigmentation | Skin and subcutaneous tissue disorders | 0/23 | 2/23 |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Northwestern University | Chicago, Illinois | United States | |
+Publications
- Results publication: Ibrahim O, Khan M, Bolotin D, Dubina M, Nodzenski M, Disphanurat W, Kakar R, Yoo S, Whiting D, West DP, Poon E, Veledar E, Alam M. Treatment of keratosis pilaris with 810-nm diode laser: a randomized clinical trial. JAMA Dermatol. 2015 Feb;151(2):187-91. doi: 10.1001/jamadermatol.2014.2211. PMID 25372313
+Investigators