Trial Comparing Efficacy of Treatments for Hidradenitis Suppurativa
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ClinicalTrials.gov Identifier: NCT01063270 |
Recruitment Status
: Unknown
Verified March 2013 by Iltefat Hamzavi, Henry Ford Health System.
Recruitment status was: Active, not recruiting
First Posted
: February 5, 2010
Last Update Posted
: March 29, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hidradenitis Suppurativa | Drug: Clindamycin & Rifampin Procedure: Clindamycin + Rifampin along with NdYag Laser treatment | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Antibiotics |
Drug: Clindamycin & Rifampin
Clindamycin 300mg twice daily for 10 weeks and Rifampin 300mg twice daily for 10 weeks
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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.
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- Number and severity of lesions [ Time Frame: 5 total clinic visits over 6 month period ]
- Change in quality of life during treatment [ Time Frame: 5 total clinic visits over 6 month period ]
- Recurrence of disease [ Time Frame: 5 total clinic visits over 6 month period ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063270
United States, Michigan | |
Henry Ford Hospital Department of Dermatology. 3031 West Grand Blvd, Suite 800 | |
Detroit, Michigan, United States, 48202 |
Principal Investigator: | Iltefat Hamzavi, M.D. | Henry Ford Health System |
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 Key Record Dates |
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 |