Clinical trial NCT01063270: Trial Comparing Efficacy of Treatments for Hidradenitis Suppurativa
Official title: Randomized Control Trial Comparing Efficacy of Antibiotic Therapy Alone Versus Antibiotic Therapy in Conjunction With Quadruple Pulse Therapy Using NdYag Laser in Treatment of Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
Antibiotics
Laser
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2010-02-05
Enrollment: 18
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to further evaluate the efficacy of two treatment regimens for the treatment of hidradenitis suppurativa. This is a randomized controlled study. Patients will be randomly assigned to an arm of the study.

Detailed description: Histological studies suggest that HS is a disease of the follicles with apocrine involvement as a secondary event. The investigators have identified in a previous study that the Nd Yag laser is highly effective for decreasing the inflammation, pain, suppuration and frequency of recurrence of HS. Oral antibiotic therapy with Clindamycin and Rifampin has also been reported in previous studies to be a highly effective treatment regimen for HS and is commonly used by physicians in medical management of HS. The investigators would like to compare the efficacy of NdYag laser treatment combined with antibiotics versus treatment with antibiotics alone. The goal is to evaluate the success of these two treatment regimens on existent HS lesions as well as prevention of recurrence. There will be approximately 18 people in this research study at Henry Ford Health System (HFHS).

Eligibility criteria: Inclusion Criteria:

1. Be at least 16 years old and weigh a minimum of 80lbs. Weight requirement is for the purpose of maintaining safe clindamycin and rifampin dosing regimens.
2. Be otherwise healthy
3. Have a diagnosis of HS
4. Patients must have Hurley stage II HS, with one or more widely separated recurrent abscesses, with tract and scarring. Involvement should be bilateral and symmetric on axillae, inguinal regions or inframammary regions
5. Agree to abide by the Investigator's guidelines regarding photosensitizing drugs
6. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
7. Agree to follow and undergo all study-related procedures

Exclusion Criteria:

1. Patients with HS Hurley stage I and III will be excluded from participation in the study
2. Patients who are currently pregnant will not be able to take part in the study due to the unknown effects of antibiotics
3. Concomitant use of systemic or topical treatments for HS not involved in current study. 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
4. Exacerbation of the patient's original condition expressed clinically by a shift from Hurley Stage II to Stage III
5. Patient is unable to take antibiotic therapy
6. Any reason the investigator feels the patient should not participate in the study

Primary outcomes:
measure: Number and severity of lesions
timeFrame: 5 total clinic visits over 6 month period
Secondary outcomes:
measure: Change in quality of life during treatment
timeFrame: 5 total clinic visits over 6 month period
measure: Recurrence of disease
timeFrame: 5 total clinic visits over 6 month period
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital Department of Dermatology. 3031 West Grand Blvd, Suite 800
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Iltefat Hamzavi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: