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Trial Comparing Efficacy of Treatments for Hidradenitis Suppurativa

Primary Purpose

Hidradenitis Suppurativa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clindamycin & Rifampin
Clindamycin + Rifampin along with NdYag Laser treatment
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis Suppurativa, Antibiotics, Laser

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Oral Antibiotics

Topical Antibiotics and Laser treatment

Arm Description

Outcomes

Primary Outcome Measures

Number and severity of lesions

Secondary Outcome Measures

Change in quality of life during treatment
Recurrence of disease

Full Information

First Posted
February 2, 2010
Last Updated
July 20, 2022
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT01063270
Brief Title
Trial Comparing Efficacy of Treatments for Hidradenitis Suppurativa
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 Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis Suppurativa, Antibiotics, Laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Antibiotics
Arm Type
Active Comparator
Arm Title
Topical Antibiotics and Laser treatment
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Clindamycin & Rifampin
Intervention Description
Clindamycin 300mg twice daily for 10 weeks and Rifampin 300mg twice daily for 10 weeks
Intervention Type
Procedure
Intervention Name(s)
Clindamycin + Rifampin along with NdYag Laser treatment
Intervention Description
Clindamycin 300mg twice daily for 2 weeks Rifampin 300mg twice daily for 2 weeks along with 3 NdYag laser sessions.
Primary Outcome Measure Information:
Title
Number and severity of lesions
Time Frame
5 total clinic visits over 6 month period
Secondary Outcome Measure Information:
Title
Change in quality of life during treatment
Time Frame
5 total clinic visits over 6 month period
Title
Recurrence of disease
Time Frame
5 total clinic visits over 6 month period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iltefat Hamzavi, M.D.
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital Department of Dermatology. 3031 West Grand Blvd, Suite 800
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

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Trial Comparing Efficacy of Treatments for Hidradenitis Suppurativa

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