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

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

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Procedure: CO2 (carbon dioxide) laser; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Be at least 13 years old
2. Be otherwise healthy
3. Have a diagnosis of HS
4. Patients must have Hurley Stage II HS affecting the axilla, with one or more widely separated recurrent abscesses, with formation of a sinus tract and/or scarring
5. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
6. Agree to follow and undergo all study-related procedures
7. If applicable, minors must have permission of legal guardian for participation in the study

Exclusion criteria:

1. Patients with HS Hurley stage I and III will be excluded from participation
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. Any reason the investigator feels the patient should not participate in the study
4. If a patient misses ≥ 2 consecutive study visits, the patient will be excluded from further participation in this trial
5. History of allergy to lidocaine or topical anesthetics
6. Patients with a history of vitiligo as the CO2 laser may cause new spots of depigmentation
7. Patients with a pacemaker/defibrillator in place
8. Patients who have previously undergone surgical intervention and recurred in the axilla to be treated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CO2 (carbon dioxide) laser; Patients randomized to this group will undergo CO2 laser excision of the sinus tracts in affected axilla	Procedure: CO2 (carbon dioxide) laser
Active Comparator: Surgical Deroofing; Patients randomized to this group will undergo surgical deroofing of the sinus tracts in affected axilla	Procedure: Surgical Deroofing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Measures	Quality of Life measures will be measured via DLQI and Skindex29 patient surveys.	June 2014-February 2014

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2015
• Primary Completion (Actual): December 20, 2015
• Study Completion (Actual): June 7, 2016

Study Registration Dates

• First Submitted: June 12, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 16, 2014

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Hidradenitis suppurativa
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: 8606