Clinical Trial: Study to Compare Two Treatments for Axillary Hidradenitis Suppurativa: Carbon Dioxide Laser Versus Surgical Deroofing

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Prospective, Randomized, Controlled Clinical Trial Comparing the Efficacy Carbon Dioxide (CO2) Laser Excision Versus Surgical Deroofing in the Treatment of Hidradenitis

Brief Summary: This study compares two well-known treatment options for Stage 2 hidradenitis suppurativa: carbon dioxide (CO2) laser excision versus surgical deroofing.

Detailed Summary:

  • We will be treating patients with Stage 2 (interconnected sinus tracts and nodules) hidradenitis suppurativa who have somewhat active involvement (including drainage) in the axillae. We will only be treating ONE axilla per patient.
  • After patients are screened and deemed appropriate candidates, they will be randomized to a treatment group: CO2 laser excision or surgical deroofing.
  • For each patient, there will be a single intervention (either CO2 laser excision or surgical deroofing), after which there will be 5 planned follow-up appointment at following intervals: 1 week, 2 weeks, 4 weeks, 3 months, 6 months. This will take place over course of 6 months for each patient.
  • During the study, subjects will be asked to provide information on quality of life measures, and filling out questionnaires (DLQI and Skindex29) at each visit.

  • Inclusion criteria:

    1. Be at least 13 years old and have a diagnosis of hidradenitis affecting the underarms.
    2. Agree to follow and undergo all study-related procedures, and follow-up over six month period.

  • Exclusion criteria:

    1. Patients who have already undergone surgical excision to affected area.
    2. Patients who are pregnant or breast feeding will not be able to take part in the study due to the unknown effects of CO2 laser in pregnant females, as well as risk of lidocaine use during pregnancy and breastfeeding
    3. Patients with a history
      Sponsor: Henry Ford Health System

      Current Primary Outcome: Quality of Life Measures [ Time Frame: June 2014-February 2014 ]

      Quality of Life measures will be measured via DLQI and Skindex29 patient surveys.


      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      Original Secondary Outcome:

      Information By: Henry Ford Health System

      Dates:
      Date Received: June 12, 2014
      Date Started: March 2014
      Date Completion:
      Last Updated: June 13, 2014
      Last Verified: June 2014