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Trial Comparing Efficacy of Treatments for Hidradenitis Suppurativa

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2013 by Henry Ford Health System.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01063270
First received: February 2, 2010
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  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:

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   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
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

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
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

ClinicalTrials.gov processed this record on September 23, 2016