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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	Related Studies

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

This study has been terminated.
Information provided by University of California, Davis

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

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 ]

Secondary Outcome Measure ^†

Condition ^†

Hidradenitis Suppurativa

Intervention ^†

Device: 1320nm Nd: YAG nonablative laser

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Terminated

Enrollment ^†

Start Date ^†

April 2005

Completion Date

April 2006

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00367328

Organization ID

200513081-1

Secondary IDs ^††

Study Sponsor ^†

University of California, Davis

Collaborators ^††

CoolTouch, Inc

Investigators ^†

Principal Investigator:

Daniel Eisen, M.D.

University of California, Davis

Information Provided By

University of California, Davis

Verification Date

June 2008

First Received Date ^†

August 19, 2006

Last Updated Date

June 17, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.