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

This study has been terminated.
(Terminated: recruiting or enrolling participants has halted.)
CoolTouch, Inc
Information provided by (Responsible Party):
University of California, Davis Identifier:
First received: August 19, 2006
Last updated: April 6, 2015
Last verified: April 2015
A research study to determine the efficacy of a 1320 nm laser device for the treatment of hidradenitis suppurativa.

Condition Intervention Phase
Hidradenitis Suppurativa Device: 1320nm Nd: YAG nonablative laser Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: April 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  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 identifier: NCT00367328

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
Principal Investigator: Daniel Eisen, M.D. University of California, Davis
  More Information

Additional Information:
Responsible Party: University of California, Davis Identifier: NCT00367328     History of Changes
Other Study ID Numbers: 200513081-1
Study First Received: August 19, 2006
Last Updated: April 6, 2015

Keywords provided by University of California, Davis:
Hidradenitis Supperativa

Additional relevant MeSH terms:
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Suppuration processed this record on September 21, 2017