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Completed

NCT Number: NCT02163746

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

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

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Key information

Age range

13 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO2 (carbon dioxide) laser

Procedure

Surgical Deroofing

Procedure

Primary outcomes

  1. Quality of Life Measures

    Time frame: June 2014-February 2014

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

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

A Prospective, Randomized, Controlled Clinical Trial Comparing the Efficacy Carbon Dioxide (CO2) Laser Excision Versus Surgical Deroofing in the Treatment of Hidradenitis Suppurativa

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 16, 2014
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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