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To Determine the Efficacy of a Laser Device for the Treatment of Hidradenitis Suppurativa

This study has been terminated.
Information provided by University of California, Davis

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Descriptive Information Fields
Brief Title  To Determine the Efficacy of a Laser Device for the Treatment of Hidradenitis Suppurativa
Official Title  To Determine The Efficacy Of A 1320nm Nd: YAG Nonablative Laser For Treatment of Hidradenitis Suppurativa
Brief Summary

A research study to determine the efficacy of a 1320 nm laser device for the treatment of hidradenitis suppurativa.

Detailed Description

Hidradenitis Suppurativa is a chronic, scarring disease. The treatments available for this condition are not very effective and work only for some patients.

Recently, a 1320nm laser device has been approved by the FDA for the treatment of acne and facial rejuvenation. Given the positive results seen with the use of this laser in the treatment of acne it is reasonable to hypothesize that a similar effect may be seen with the treatment of Hidradenitis suppurativa.

The specific aim of the study is to determine the efficacy of this device for the treatment of hidradenitis suppurativa as it relates to the patient's established treatment.

The investigators are trying to determine the efficacy of a laser for the treatment of hidradenitis suppurativa.

Patients will:

  • be examined and interviewed
  • have photographs taken of the treatment site
  • have a 4mm punch biopsy performed
  • have wound culture swabs performed
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  A successful treatment is expected to improve the quality of life significantly by causing remission of disease. The data obtained from this study will also allow the development of laser-based treatment protocols for hidradenitis suppurativa. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  Hidradenitis Suppurativa
Intervention  Device: 1320nm Nd: YAG nonablative laser
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Terminated
Enrollment  10
Start Date  April 2005
Completion Date April 2006
Eligibility Criteria 

Inclusion Criteria:

  • Age equal to or greater than 18 years
  • General good health and willingness to participate and ability to comply with the study protocol
  • Biopsy proven hidradenitis suppurativa

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Hx of collagen vascular or photosensitive disorders
  • Inability to follow-up with treatments
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00367328
Organization ID 200513081-1
Secondary IDs ††
Study Sponsor  University of California, Davis
Collaborators †† CoolTouch, Inc
Investigators 
Principal Investigator:     Daniel Eisen, M.D.     University of California, Davis    
Information Provided By University of California, Davis
Verification Date June 2008
First Received Date  August 19, 2006
Last Updated Date June 17, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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