Keratosis Pilaris (KP)
Conditions
Keywords
Keratosis pilaris (KP)
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.
Interventions
DEVICEDiode Laser
810 nm diode laser
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Subjects Receiving Split Body Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 2 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
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).
Time frame: 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Laser Treatment | Difference in Disease Severity Scores | 4 units on a scale |
| 45-60 J Diode Laser Therapy | Difference in Disease Severity Scores | 3 units on a scale |
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).
Time frame: 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Laser Treatment | Patient Self-rated Severity | 4 units on a scale |
| 45-60 J Diode Laser Therapy | Patient Self-rated Severity | 2.5 units on a scale |