Treatment of Keratosis Pilaris With 810 nm Diode Laser

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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Key information

Conditions

Keratosis Pilaris (KP) Burnett Schwartz Berberian syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diode laser

Device

810 nm diode laser

Primary outcomes

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).

Secondary outcomes

Patient Self-rated Severity

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Acronym: KP

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Jan 24, 2011
Registry last updated: Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed