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

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. Identifier: NCT00367328
Recruitment Status : Terminated (Terminated: recruiting or enrolling participants has halted.)
First Posted : August 22, 2006
Last Update Posted : April 7, 2015
CoolTouch, Inc
Information provided by (Responsible Party):
University of California, Davis

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

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Device: 1320nm Nd: YAG nonablative laser Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: To Determine The Efficacy Of A 1320nm Nd: YAG Nonablative Laser For Treatment of Hidradenitis Suppurativa
Study Start Date : April 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A
Oral Antibiotics in standard care vs. Laser treatment
Device: 1320nm Nd: YAG nonablative laser
a 4 mm piece of skin tissue (about the size of a pencil-head eraser) from the affected area. This procedure is called a punch biopsy and will be done to confirm your diagnosis. A culture swab similar to a Q-Tip will be used to wipe the affected areas during the first visit to determine any bacteria that may be present. A survey with questions will be given at the first visit, again after 3 months and at the last visit to measure the success of the treatment. Photographs will be taken prior to each treatment and one month following your last treatment. A laser, which is a very powerful light, will be used to treat half of the skin that is affected by your condition.
Other Name: laser treatment

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00367328

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United States, California
University of California, Davis Medical Center Department of Dermatology
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
CoolTouch, Inc
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Principal Investigator: Daniel Eisen, M.D. University of California, Davis
Additional Information:
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Responsible Party: University of California, Davis Identifier: NCT00367328    
Other Study ID Numbers: 200513081-1
First Posted: August 22, 2006    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by University of California, Davis:
Hidradenitis Supperativa
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Skin Diseases, Infectious