Back to resultsTreatment of Keratosis Pilaris With 810 nm Diode Laser (KP)
Primary Purpose
Keratosis Pilaris (KP)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diode Laser
Sponsored by
About this trial
This is an interventional treatment trial for Keratosis Pilaris (KP) focused on measuring Keratosis pilaris (KP)
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
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
No Laser Treatment
45-60 J Diode Laser Therapy
Arm Description
Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT01281644
First Posted
January 20, 2011
Last Updated
December 2, 2021
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT01281644
Brief Title
Treatment of Keratosis Pilaris With 810 nm Diode Laser
Acronym
KP
Official Title
Treatment of Keratosis Pilaris With 810 nm Diode Laser
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratosis Pilaris (KP)
Keywords
Keratosis pilaris (KP)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Laser Treatment
Arm Type
No Intervention
Arm Title
45-60 J Diode Laser Therapy
Arm Type
Active Comparator
Arm Description
Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.
Intervention Type
Device
Intervention Name(s)
Diode Laser
Intervention Description
810 nm diode laser
Primary Outcome Measure Information:
Title
Difference in Disease Severity Scores
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Patient Self-rated Severity
Description
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).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25372313
Citation
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.
Results Reference
derived
Learn more about this trial
Treatment of Keratosis Pilaris With 810 nm Diode Laser
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