To Determine the Efficacy of a Laser Device for the Treatment of Hidradenitis Suppurativa
Primary Purpose
Hidradenitis Suppurativa
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
1320nm Nd: YAG nonablative laser
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis Supperativa
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
Sites / Locations
- University of California, Davis Medical Center Department of Dermatology
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
A
Arm Description
Oral Antibiotics in standard care vs. Laser treatment
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00367328
First Posted
August 19, 2006
Last Updated
April 6, 2015
Sponsor
University of California, Davis
Collaborators
CoolTouch, Inc
1. Study Identification
Unique Protocol Identification Number
NCT00367328
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Terminated: recruiting or enrolling participants has halted.
Study Start Date
April 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
CoolTouch, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis Supperativa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Oral Antibiotics in standard care vs. Laser treatment
Intervention Type
Device
Intervention Name(s)
1320nm Nd: YAG nonablative laser
Other Intervention Name(s)
laser treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Eisen, M.D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Medical Center Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.ucdmc.ucdavis.edu/dermatology/research/clinical
Description
University of California-Davis Department of Dermatology Clinical Research
Learn more about this trial
To Determine the Efficacy of a Laser Device for the Treatment of Hidradenitis Suppurativa
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