Trial Comparing Efficacy of Treatments for Hidradenitis Suppurativa

NCT01063270 | Completed DMC

• 1 other identifier: IRB5974
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa; Antibiotics; Laser

Outcome Measures

Primary Outcomes (1)

• Number and severity of lesions

  5 total clinic visits over 6 month period

Secondary Outcomes (2)

• Change in quality of life during treatment

  5 total clinic visits over 6 month period

• Recurrence of disease

  5 total clinic visits over 6 month period

Study Arms (2)

Oral Antibiotics

ACTIVE COMPARATOR

Drug: Clindamycin & Rifampin

Topical Antibiotics and Laser treatment

ACTIVE COMPARATOR

Procedure: Clindamycin + Rifampin along with NdYag Laser treatment

Interventions

Clindamycin & Rifampin DRUG

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

Oral Antibiotics

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.

Topical Antibiotics and Laser treatment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

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

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Clindamycin; Rifampin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Iltefat Hamzavi, M.D.

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 5, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2013
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

US (1)