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

April 6, 2015 updated by: University of California, Davis

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis Medical Center Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • laser treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

CoolTouch, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

August 19, 2006

First Submitted That Met QC Criteria

August 21, 2006

First Posted (Estimate)

August 22, 2006

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200513081-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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