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

NCT ID: NCT02163746

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-14
• Study Completion Date: 2016-06-07

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.

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CO2 (carbon dioxide) laser

Patients randomized to this group will undergo CO2 laser excision of the sinus tracts in affected axilla

Group Type: ACTIVE_COMPARATOR

CO2 (carbon dioxide) laser

Intervention Type: PROCEDURE

Surgical Deroofing

Patients randomized to this group will undergo surgical deroofing of the sinus tracts in affected axilla

Group Type: ACTIVE_COMPARATOR

Surgical Deroofing

Intervention Type: PROCEDURE

Interventions

CO2 (carbon dioxide) laser

Intervention Type: PROCEDURE

Surgical Deroofing

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Iltefat Hamzavi

Senior Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henry Ford Health System

Detroit, Michigan, United States

Countries

United States

Other Identifiers

8606

Identifier Type: -

Identifier Source: org_study_id