Trial Comparing Efficacy of Treatments for Hidradenitis Suppurativa

NCT ID: NCT01063270

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-12-31

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).

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Oral Antibiotics

Group Type: ACTIVE_COMPARATOR

Clindamycin & Rifampin

Intervention Type: DRUG

Clindamycin 300mg twice daily for 10 weeks and Rifampin 300mg twice daily for 10 weeks

Topical Antibiotics and Laser treatment

Group Type: ACTIVE_COMPARATOR

Clindamycin + Rifampin along with NdYag Laser treatment

Intervention Type: PROCEDURE

Clindamycin 300mg twice daily for 2 weeks Rifampin 300mg twice daily for 2 weeks along with 3 NdYag laser sessions.

Interventions

Clindamycin & Rifampin

Clindamycin 300mg twice daily for 10 weeks and Rifampin 300mg twice daily for 10 weeks

Intervention Type: DRUG

Clindamycin + Rifampin along with NdYag Laser treatment

Clindamycin 300mg twice daily for 2 weeks Rifampin 300mg twice daily for 2 weeks along with 3 NdYag laser sessions.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Iltefat Hamzavi

Dermatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iltefat Hamzavi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

Henry Ford Hospital Department of Dermatology. 3031 West Grand Blvd, Suite 800

Detroit, Michigan, United States

Countries

United States

Other Identifiers

IRB5974

Identifier Type: -

Identifier Source: org_study_id