To Determine the Efficacy of a Laser Device for the Treatment of Hidradenitis Suppurativa - Full Text View

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 III

MedlinePlus related topics:

Hidradenitis Suppurativa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Official Title:	To Determine The Efficacy Of A 1320nm Nd: YAG Nonablative Laser For Treatment of Hidradenitis Suppurativa

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

A: Active Comparator

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.

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

Responsible Party:	UC Davis ( Daniel Eisen, M.D. )
Study ID Numbers:	200513081-1
First Received:	August 19, 2006
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00367328
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by University of California, Davis:

Hidradenitis Supperativa

Study placed in the following topic categories:

Skin Diseases, Infectious

Skin Diseases, Bacterial

Suppuration

Hidradenitis

Hidradenitis suppurativa

Hidradenitis Suppurativa

Additional relevant MeSH terms:

Bacterial Infections

Skin Diseases

Sweat Gland Diseases

Infection

ClinicalTrials.gov processed this record on July 03, 2008

Sponsors and Collaborators:	University of California, Davis CoolTouch, Inc
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00367328