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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01281644
First received: January 20, 2011
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Keratosis Pilaris (KP)
Device: Diode Laser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Keratosis Pilaris With 810 nm Diode Laser

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Difference in severity scores [ Time Frame: 4 wks ] [ Designated as safety issue: No ]
    Difference in the overall blind rater severity scores of the treated versus the untreated sites


Secondary Outcome Measures:
  • Patient self-rated severity [ Time Frame: 4 wks ] [ Designated as safety issue: No ]
    Change in the patient's self-rated severity score of the treated site.


Enrollment: 23
Study Start Date: March 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281644

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

Responsible Party: Murad Alam, Associate Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01281644     History of Changes
Other Study ID Numbers: MA111810
Study First Received: January 20, 2011
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Keratosis pilaris (KP)

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Abnormalities, Multiple
Darier Disease
Skin Diseases
Precancerous Conditions
Neoplasms
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 21, 2014