Hidradenitis Suppurativa Clinical Trial
Official title:
Prospective Controlled Study of the Efficacy of NdYag for Hidradenitis Suppurativa
Verified date | May 2010 |
Source | Henry Ford Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
- Determination of the short and long term efficacy of NdYag laser for treatment of
Hidradenitis suppurativa, which is an inflamed, deeper follicular disorders.
- Determination of patient tolerance of discomfort associated with NdYag laser treatment
for Hidradenitis suppurativa.
- Determination of the impact of this condition on quality of life and if there is any
impact of therapy in the dermatology quality of life index.
- Evaluate the histopathologic changes of YAG therapy on affected skin
Second phase of study:
- Prospective, controlled clinical and histologic study of patients with Hurley Stage II
HS disease.
- 19 patients of skin types II to VI with Hurley Stage II hidradenitis suppurativa
lesions of the axilla and groin. This is a different set of patients than those treated
in the first phase of the study above. This study primarily focuses on and further
characterizes the histologic changes after laser treatment.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: For inclusion, the subject must: - Be at least 18 years old - Be otherwise healthy - Have a diagnosis of HS - Patients with Hurley stage II, with one ore more widely separated recurrent abscesses, with a tract and scarring, bilateral and symmetrical, will be eligible for inclusion in the study. - Agree to abide by the Investigator's guidelines regarding photosensitizing drugs - Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form - Agree to follow and undergo all study-related procedures. Exclusion Criteria: - Patients with Hidradenitis Hurley state I and III will be excluded from participation in the study. - The control for this study will be the patient's opposite side of the body, i.e., for patients treated on the left axilla, the right axilla will serve as the corresponding control. - Concomitant use of systemic or topical treatments for HS. Patients must discontinue all forms of oral therapy as systemic and topical antibiotics and retinoids for 2 weeks prior to the start of any treatment. - Exacerbation of the patient's original condition expressed clinically by a shift from Hurley Stage II to Stage III. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard, | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Henry Ford Health System |
United States,
Krasner BD, Hamzavi FH, Murakawa GJ, Hamzavi IH. Dissecting cellulitis treated with the long-pulsed Nd:YAG laser. Dermatol Surg. 2006 Aug;32(8):1039-44. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | We will be measuring patients' response by the clinical scoring criteria of the Hidradenitis Suppurativa European Research Group (HISERG) scale. | 6 months | Yes | |
Primary | Examining histologic changes at various time points following 1064 nm Nd:YAG laser treatment of hidradenitis suppurativa. | 6 months. | Yes | |
Secondary | Completion of a post treatment survey regarding the pain of the treatment, pain of their skin condition after treatment, frequency of breakouts, effectiveness of treatment, overall level of satisfaction, likelihood to use the treatment again. | Monthly, through 6 months | Yes |
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