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

Phase 3

Terminated

• Conditions: Hidradenitis Suppurativa

• Registration Number: NCT00367328
• Lead Sponsor: University of California, Davis

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 Timeline

• Study Start: 2005-04
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2006-08-19
• Study First Submitted QC: 2006-08-21
• Study First Posted: 2006-08-22
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

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Exclusion Criteria

• Age < 18 years
• Pregnancy
• Hx of collagen vascular or photosensitive disorders
• Inability to follow-up with treatments

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of California, Davis Medical Center Department of Dermatology; 🇺🇸 Sacramento, California, United States