Trial Comparing Efficacy of Treatments for Hidradenitis Suppurativa

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hidradenitis Suppurativa	Drug: Clindamycin & Rifampin; Procedure: Clindamycin + Rifampin along with NdYag Laser treatment	Not Applicable

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).

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	18 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	February 2010
Actual Primary Completion Date :	July 2011
Estimated Study Completion Date :	December 2013

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Antibiotics	Drug: Clindamycin & Rifampin; Clindamycin 300mg twice daily for 10 weeks and Rifampin 300mg twice daily for 10 weeks
Active Comparator: Antibiotics and Laser treatment	Procedure: 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.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Number and severity of lesions [ Time Frame: 5 total clinic visits over 6 month period ]

Secondary Outcome Measures :

1. Change in quality of life during treatment [ Time Frame: 5 total clinic visits over 6 month period ]
2. Recurrence of disease [ Time Frame: 5 total clinic visits over 6 month period ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Michigan
Henry Ford Hospital Department of Dermatology. 3031 West Grand Blvd, Suite 800
Detroit, Michigan, United States, 48202

Sponsors and Collaborators

Henry Ford Health System

Investigators

Principal Investigator:	Iltefat Hamzavi, M.D.	Henry Ford Health System

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Iltefat Hamzavi, Dermatologist, Henry Ford Health System
ClinicalTrials.gov Identifier:	NCT01063270 History of Changes
Other Study ID Numbers:	IRB5974
First Posted:	February 5, 2010
Last Update Posted:	March 29, 2013
Last Verified:	March 2013

Keywords provided by Iltefat Hamzavi, Henry Ford Health System:

Hidradenitis Suppurativa; Antibiotics; Laser

Additional relevant MeSH terms:

Hidradenitis; Hidradenitis Suppurativa; Sweat Gland Diseases; Skin Diseases; Skin Diseases, Bacterial; Bacterial Infections; Skin Diseases, Infectious; Infection; Suppuration; Anti-Bacterial Agents; Rifampin; Clindamycin; Clindamycin palmitate; Clindamycin phosphate

Antibiotics, Antitubercular; Anti-Infective Agents; Antitubercular Agents; Leprostatic Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Cytochrome P-450 CYP3A Inducers; Protein Synthesis Inhibitors