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

Not Applicable

Completed

• Conditions: Hidradenitis Suppurativa
• Interventions: Procedure: Surgical Deroofing; Procedure: CO2 (carbon dioxide) laser

• Registration Number: NCT02163746
• Lead Sponsor: Henry Ford Health System

Brief 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.

Study Timeline

• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-16
• Study Start: 2015-01-14
• Primary Completion: 2015-12-20
• Study Completion: 2016-06-07
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical Deroofing	Surgical Deroofing	Patients randomized to this group will undergo surgical deroofing of the sinus tracts in affected axilla
CO2 (carbon dioxide) laser	CO2 (carbon dioxide) laser	Patients randomized to this group will undergo CO2 laser excision of the sinus tracts in affected axilla

Primary Outcome Measures

Name	Time	Method
Quality of Life Measures	June 2014-February 2014	Quality of Life measures will be measured via DLQI and Skindex29 patient surveys.

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States