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Terminated: recruiting or enrolling participants has halted.
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| Name | Class |
|---|---|
| CoolTouch, Inc | INDUSTRY |
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A research study to determine the efficacy of a 1320 nm laser device for the treatment of hidradenitis suppurativa.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Oral Antibiotics in standard care vs. Laser treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1320nm Nd: YAG nonablative laser | Device | 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. |
| Measure | Description | 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Eisen, M.D. | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Medical Center Department of Dermatology | Sacramento | California | 95817 | United States |
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| Label | URL |
|---|---|
| University of California-Davis Department of Dermatology Clinical Research | View source |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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|
|
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |