Treatment of Keratosis Pilaris With 810 nm Diode Laser

NCT01281644 | Completed Results DMC

• 1 other identifier: MA111810
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratosis Pilaris (KP)

Keywords

Keratosis pilaris (KP)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Self-rated Severity

  12 weeks

Study Arms (2)

No Laser Treatment

NO INTERVENTION

45-60 J Diode Laser Therapy

ACTIVE COMPARATOR

Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.

Device: Diode Laser

Interventions

Diode Laser DEVICE

810 nm diode laser

45-60 J Diode Laser Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 25372313 DERIVED

MeSH Terms

Conditions

Burnett Schwartz Berberian syndrome

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Dr. Murad Alam
• Organization: Northwestern University

m-alam@northwestern.edu

312-695-4761

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 24, 2011
• Study Start: March 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 6, 2021
• Results First Posted: October 20, 2014

Record last verified: 2021-12

Locations

US (1)