Study to Compare Two Treatments for Axillary Hidradenitis Suppurativa: Carbon Dioxide Laser Versus Surgical Deroofing
Primary Purpose
Hidradenitis Suppurativa
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CO2 (carbon dioxide) laser
Surgical Deroofing
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis suppurativa
Eligibility Criteria
Inclusion Criteria:
- Be at least 13 years old
- Be otherwise healthy
- Have a diagnosis of HS
- 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
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
- Agree to follow and undergo all study-related procedures
- If applicable, minors must have permission of legal guardian for participation in the study
Exclusion criteria:
- Patients with HS Hurley stage I and III will be excluded from participation
- 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
- Any reason the investigator feels the patient should not participate in the study
- If a patient misses ≥ 2 consecutive study visits, the patient will be excluded from further participation in this trial
- History of allergy to lidocaine or topical anesthetics
- Patients with a history of vitiligo as the CO2 laser may cause new spots of depigmentation
- Patients with a pacemaker/defibrillator in place
- Patients who have previously undergone surgical intervention and recurred in the axilla to be treated
Sites / Locations
- Henry Ford Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CO2 (carbon dioxide) laser
Surgical Deroofing
Arm Description
Patients randomized to this group will undergo CO2 laser excision of the sinus tracts in affected axilla
Patients randomized to this group will undergo surgical deroofing of the sinus tracts in affected axilla
Outcomes
Primary Outcome Measures
Quality of Life Measures
Quality of Life measures will be measured via DLQI and Skindex29 patient surveys.
Secondary Outcome Measures
Full Information
NCT ID
NCT02163746
First Posted
June 12, 2014
Last Updated
February 15, 2022
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT02163746
Brief Title
Study to Compare Two Treatments for Axillary Hidradenitis Suppurativa: Carbon Dioxide Laser Versus Surgical Deroofing
Official Title
A Prospective, Randomized, Controlled Clinical Trial Comparing the Efficacy Carbon Dioxide (CO2) Laser Excision Versus Surgical Deroofing in the Treatment of Hidradenitis Suppurativa
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 14, 2015 (Actual)
Primary Completion Date
December 20, 2015 (Actual)
Study Completion Date
June 7, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
Be at least 13 years old and have a diagnosis of hidradenitis affecting the underarms.
Agree to follow and undergo all study-related procedures, and follow-up over six month period.
Exclusion criteria:
Patients who have already undergone surgical excision to affected area.
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
Patients with a history of allergy to lidocaine or topical anesthetics will not be able to take part in this study.
Patients with a history of vitiligo as the CO2 laser may cause new spots of depigmentation.
Patients with a pacemaker/defibrillator in place.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis suppurativa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CO2 (carbon dioxide) laser
Arm Type
Active Comparator
Arm Description
Patients randomized to this group will undergo CO2 laser excision of the sinus tracts in affected axilla
Arm Title
Surgical Deroofing
Arm Type
Active Comparator
Arm Description
Patients randomized to this group will undergo surgical deroofing of the sinus tracts in affected axilla
Intervention Type
Procedure
Intervention Name(s)
CO2 (carbon dioxide) laser
Intervention Type
Procedure
Intervention Name(s)
Surgical Deroofing
Primary Outcome Measure Information:
Title
Quality of Life Measures
Description
Quality of Life measures will be measured via DLQI and Skindex29 patient surveys.
Time Frame
June 2014-February 2014
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be at least 13 years old
Be otherwise healthy
Have a diagnosis of HS
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
Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
Agree to follow and undergo all study-related procedures
If applicable, minors must have permission of legal guardian for participation in the study
Exclusion criteria:
Patients with HS Hurley stage I and III will be excluded from participation
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
Any reason the investigator feels the patient should not participate in the study
If a patient misses ≥ 2 consecutive study visits, the patient will be excluded from further participation in this trial
History of allergy to lidocaine or topical anesthetics
Patients with a history of vitiligo as the CO2 laser may cause new spots of depigmentation
Patients with a pacemaker/defibrillator in place
Patients who have previously undergone surgical intervention and recurred in the axilla to be treated
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Compare Two Treatments for Axillary Hidradenitis Suppurativa: Carbon Dioxide Laser Versus Surgical Deroofing
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