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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00367328
Other study ID # 200513081-1
Secondary ID
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


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
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