Keratosis Pilaris (KP)KPNCT01281644
Treatment of Keratosis Pilaris With 810 nm Diode Laser
A study testing Diode Laser in people with Keratosis Pilaris (KP), run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Keratosis Pilaris (KP)
- What is being tested?
- Diode Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Keratosis Pilaris (KP)
- Being tested
- Diode Laser
- Keywords
- Keratosis pilaris (KP)
- Medical subject headings
- Burnett Schwartz Berberian syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode LaserDevice
810 nm diode laser
| Study group | Role | What they receive |
|---|---|---|
| No Laser Treatment | No intervention | Not described |
| 45-60 J Diode Laser Therapy | Active comparator | Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms. Receives: Device: Diode Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (1)
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Keratosis Pilaris (KP)Studies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281644
- Sponsor's protocol ID
- MA111810
- Acronym
- KP
- Status last verified
- Dec 2021
- First submitted
- 20 Jan 2011
- Last updated
- 6 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25372313
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Keratosis Pilaris With 810 nm Diode Laser
- ClinicalTrials.gov ID
- NCT01281644
- Acronym / sponsor ID
- KP / MA111810
- Conditions
- Keratosis Pilaris (KP)
- Keywords
- Keratosis pilaris (KP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 24 Jan 2011 (estimated)
- Results
- Posted 20 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Laser Treatment | No intervention | – |
| 45-60 J Diode Laser Therapy | Active comparator | Device: Diode LaserDiode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diode Laser810 nm diode laser | Device | 45-60 J Diode Laser Therapy |
Primary outcome
Difference in Disease Severity Scores
Time frame: 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).
1 secondary outcome
Patient Self-rated Severity
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25372313Ibrahim 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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Keratosis Pilaris (KP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode Laser in people with Keratosis Pilaris (KP), run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Disease Severity Scores (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01281644, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.