An interventional study of Diode Laser in Keratosis Pilaris (KP), sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-12-06.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.
Device: Diode Laser
810 nm diode laser
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
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
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.
| Milestone | Subjects Receiving Split Body Treatment |
|---|---|
| Started | 23 |
| Completed | 18 |
| Not completed | 5 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Withdrawal by subject | 2 |
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).
| units on a scale | No Laser Treatment | 45-60 J Diode Laser Therapy |
|---|---|---|
| Difference in Disease Severity Scores | 4 (3 to 5) | 3 (2 to 4) |
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).
| units on a scale | No Laser Treatment | 45-60 J Diode Laser Therapy |
|---|---|---|
| Patient Self-rated Severity | 4 (3 to 4) | 2.5 (2 to 4) |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Laser Treatment | — | 0/23 (0%) | 0/23 (0%) |
| 45-60 J Diode Laser Therapy | — | 0/23 (0%) | 2/23 (8.7%) |
| Event | No Laser Treatment | 45-60 J Diode Laser Therapy |
|---|---|---|
| post-inflammatory hyperpigmentationSkin and subcutaneous tissue disorders | 0/23 | 2/23 |
| Age, Categorical(Participants) | Subjects Receiving Split Body Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 18 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Subjects Receiving Split Body Treatment |
|---|---|
| Female | 15 |
| Male | 3 |
The record gives a start of Mar 2011, a primary completion of Oct 2011 and a completion of Oct 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2014, 3 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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