Trial Comparing Efficacy of Treatments for Hidradenitis Suppurativa - Full Text View

Purpose

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	Intervention
Hidradenitis Suppurativa	Drug: Clindamycin & Rifampin Procedure: Clindamycin + Rifampin along with NdYag Laser treatment


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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

Resource links provided by NLM:

Genetics Home Reference related topics: hidradenitis suppurativa

MedlinePlus related topics: Antibiotics Hidradenitis Suppurativa

Drug Information available for: Rifampin Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin palmitate hydrochloride Clindamycin palmitate

U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:

Number and severity of lesions [ Time Frame: 5 total clinic visits over 6 month period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in quality of life during treatment [ Time Frame: 5 total clinic visits over 6 month period ] [ Designated as safety issue: No ]
Recurrence of disease [ Time Frame: 5 total clinic visits over 6 month period ] [ Designated as safety issue: No ]


Enrollment:	18
Study Start Date:	February 2010
Estimated Study Completion Date:	December 2013
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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


Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
Be otherwise healthy
Have a diagnosis of HS
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
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 HS Hurley stage I and III will be excluded from participation in the study
Patients who are currently pregnant will not be able to take part in the study due to the unknown effects of antibiotics
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
Exacerbation of the patient's original condition expressed clinically by a shift from Hurley Stage II to Stage III
Patient is unable to take antibiotic therapy
Any reason the investigator feels the patient should not participate in the study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063270

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

No publications provided


Responsible Party:	Iltefat Hamzavi, Dermatologist, Henry Ford Health System
ClinicalTrials.gov Identifier:	NCT01063270 History of Changes
Other Study ID Numbers:	IRB5974
Study First Received:	February 2, 2010
Last Updated:	March 27, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Henry Ford Health System:


Hidradenitis Suppurativa Antibiotics Laser

Additional relevant MeSH terms:


Hidradenitis Hidradenitis Suppurativa Bacterial Infections Infection Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Suppuration Sweat Gland Diseases Anti-Bacterial Agents Antibiotics, Antitubercular Clindamycin	Clindamycin palmitate Clindamycin phosphate Rifampin Anti-Infective Agents Antitubercular Agents Enzyme Inhibitors Leprostatic Agents Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Protein Synthesis Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015