Treatment of Keratosis Pilaris With 810 nm Diode Laser (KP)

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 Overview

• Status: Completed
• Conditions: Keratosis Pilaris (KP)
• Intervention / Treatment: Device: Diode Laser

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Laser Treatment
Active Comparator: 45-60 J Diode Laser Therapy; Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.	Device: Diode Laser; 810 nm diode laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 weeks

Collaborators and Investigators

• Sponsor: Northwestern University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: January 21, 2011
• First Posted (Estimate): January 24, 2011

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Keratosis pilaris (KP)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Congenital Abnormalities; Genetic Diseases, Inborn; Skin Diseases, Genetic; Precancerous Conditions; Keratosis, Actinic; Keratosis; Abnormalities, Multiple; Darier Disease
• Other Study ID Numbers: MA111810