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

Hidradenitis Suppurativa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00367328
• Other study ID #: 200513081-1
• Status: Terminated
• Phase: Phase 3
• First received: August 19, 2006
• Last updated: April 6, 2015
• Start date: April 2005
• Est. completion date: April 2006

Study information

• Verified date: April 2015
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Davis Medical Center Department of Dermatology	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	CoolTouch, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year	No

External Links

•   University of California-Davis Department of Dermatology Clinical Research