NCT02163746

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 13 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

* 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 of allergy to lidocaine or topical anesthetics will not be able to take part in this study. 4. Patients with a history of vitiligo as the CO2 laser may cause new spots of depigmentation. 5. Patients with a pacemaker/defibrillator in place.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
PROCEDURE	CO2 (carbon dioxide) laser
PROCEDURE	Surgical Deroofing

Timeline

• Start date: 2015-01-14
• Primary completion: 2015-12-20
• Completion: 2016-06-07
• First posted: 2014-06-16
• Last updated: 2022-03-02

Locations

1 site across 1 country: United States