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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.)
Sponsor:
Collaborator:
CoolTouch, Inc
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00367328
First received: August 19, 2006
Last updated: May 7, 2009
Last verified: May 2009
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367328

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

No publications provided

Responsible Party: Daniel Eisen, M.D., UC Davis
ClinicalTrials.gov Identifier: NCT00367328     History of Changes
Other Study ID Numbers: 200513081-1
Study First Received: August 19, 2006
Last Updated: May 7, 2009
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, Davis:
Hidradenitis Supperativa

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
 Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration

ClinicalTrials.gov processed this record on May 23, 2013