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

Overview

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

Full Title of Study: “To Determine The Efficacy Of A 1320nm Nd: YAG Nonablative Laser For Treatment of Hidradenitis Suppurativa”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: April 2006

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

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: A
    • Oral Antibiotics in standard care vs. Laser treatment

Clinical Trial Outcome Measures

Primary 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

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, Davis
  • Collaborator
    • CoolTouch, Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Daniel Eisen, M.D., Principal Investigator, University of California, Davis

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