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

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ClinicalTrials.gov Identifier: NCT02163746
Recruitment Status : Unknown
Verified June 2014 by Iltefat Hamzavi, Henry Ford Health System.
Recruitment status was:  Recruiting
First Posted : June 16, 2014
Last Update Posted : June 16, 2014
Sponsor:
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System

Tracking Information
First Submitted Date  ICMJE June 12, 2014
First Posted Date  ICMJE June 16, 2014
Last Update Posted Date June 16, 2014
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
Quality of Life Measures [ Time Frame: June 2014-February 2014 ]
Quality of Life measures will be measured via DLQI and Skindex29 patient surveys.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare Two Treatments for Axillary Hidradenitis Suppurativa: Carbon Dioxide Laser Versus Surgical Deroofing
Official Title  ICMJE A Prospective, Randomized, Controlled Clinical Trial Comparing the Efficacy Carbon Dioxide (CO2) Laser Excision Versus Surgical Deroofing in the Treatment of Hidradenitis Suppurativa
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE
  • Procedure: CO2 (carbon dioxide) laser
  • Procedure: Surgical Deroofing
Study Arms  ICMJE
  • Active Comparator: CO2 (carbon dioxide) laser
    Patients randomized to this group will undergo CO2 laser excision of the sinus tracts in affected axilla
    Intervention: Procedure: CO2 (carbon dioxide) laser
  • Active Comparator: Surgical Deroofing
    Patients randomized to this group will undergo surgical deroofing of the sinus tracts in affected axilla
    Intervention: Procedure: Surgical Deroofing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 13, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02163746
Other Study ID Numbers  ICMJE 8606
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Iltefat Hamzavi, Henry Ford Health System
Study Sponsor  ICMJE Henry Ford Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Henry Ford Health System
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP