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

NCT02163746 | Completed DMC

• 1 other identifier: 8606
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis suppurativa

Outcome Measures

Primary Outcomes (1)

• Quality of Life Measures

  Quality of Life measures will be measured via DLQI and Skindex29 patient surveys.

  June 2014-February 2014

Study Arms (2)

CO2 (carbon dioxide) laser

ACTIVE COMPARATOR

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

Procedure: CO2 (carbon dioxide) laser

Surgical Deroofing

ACTIVE COMPARATOR

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

Procedure: Surgical Deroofing

Interventions

CO2 (carbon dioxide) laser PROCEDURE

CO2 (carbon dioxide) laser

Surgical Deroofing PROCEDURE

Surgical Deroofing

Eligibility Criteria

• Age: 13 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Carbon Dioxide; Lasers

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Physician

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 16, 2014
• Study Start: January 14, 2015
• Primary Completion: December 20, 2015
• Study Completion: June 7, 2016
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

US (1)