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Completed

NCT Number: NCT01063270

Trial Comparing Efficacy of Treatments for Hidradenitis Suppurativa

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.

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Detroit, Michigan, 48202, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clindamycin & Rifampin

Drug

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

Clindamycin + Rifampin along with NdYag Laser treatment

Procedure

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

Primary outcomes

  1. Number and severity of lesions

    Time frame: 5 total clinic visits over 6 month period

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
Feb 5, 2010
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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