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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Laser Treatment | No Intervention | ||
| 45-60 J Diode Laser Therapy | Active Comparator | Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diode Laser | Device | 810 nm diode laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25372313 | Derived | 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. |
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The principal investigator selected patients presenting to the Dermatology Clinic at Northwestern Memorial Hospital who met the inclusion criteria. A brief, written description of the study was given to the patient.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Receiving Split Body Treatment | The unit of randomization was the individual arm within each subject to receive either laser therapy on the right arm or on the left arm. Each subject received treatment using the 810 nm pulsed diode laser to the arm randomized to be the treatment site. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Receiving Split Body Treatment | The unit of randomization was the individual arm within each subject to receive either laser therapy on the right arm or on the left arm. Each subject received treatment using the 810 nm pulsed diode laser to the arm randomized to be the treatment site. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Median | Inter-Quartile Range | units on a scale | 12 weeks | Arm | Arm |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Laser Treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| post-inflammatory hyperpigmentation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Murad Alam | Northwestern University | 312-695-4761 | m-alam@northwestern.edu |
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| ID | Term |
|---|---|
| C537412 | Burnett Schwartz Berberian syndrome |
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| ID | Term |
|---|---|
| D054023 | Lasers, Semiconductor |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| 12 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 45-60 J Diode Laser Therapy |
Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms. Diode Laser: 810 nm diode laser |
|
|
| 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). | Posted | Median | Inter-Quartile Range | units on a scale | 12 weeks | arms | arms |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | 45-60 J Diode Laser Therapy | Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms. Diode Laser: 810 nm diode laser | 0 | 23 | 2 | 23 |
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