To Determine the Efficacy of a Laser Device for the Treatment of Hidradenitis Suppurativa
|Hidradenitis Suppurativa||Device: 1320nm Nd: YAG nonablative laser||Phase 3|
|Study Design:||Allocation: Randomized
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|
- 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 ]
|Study Start Date:||April 2005|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
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
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.
- be examined and interviewed
- have photographs taken of the treatment site
- have a 4mm punch biopsy performed
- have wound culture swabs performed
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367328
|United States, California|
|University of California, Davis Medical Center Department of Dermatology|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Daniel Eisen, M.D.||University of California, Davis|