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Trial record 2 of 3 for:    "Burnett Schwartz Berberian syndrome"

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01281644
First Posted: January 24, 2011
Last Update Posted: October 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Murad Alam, Northwestern University
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Murad Alam, Northwestern University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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).


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Murad Alam, Associate Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01281644     History of Changes
Other Study ID Numbers: MA111810
First Submitted: January 20, 2011
First Posted: January 24, 2011
Results First Submitted: August 14, 2014
Results First Posted: October 20, 2014
Last Update Posted: October 20, 2014
Last Verified: October 2014

Keywords provided by Murad Alam, 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