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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

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

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Procedure: CO2 (carbon dioxide) laser Procedure: Surgical Deroofing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2014
Estimated Primary Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CO2 (carbon dioxide) laser
Patients randomized to this group will undergo CO2 laser excision of the sinus tracts in affected axilla
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
Procedure: Surgical Deroofing



Primary Outcome Measures :
  1. Quality of Life Measures [ Time Frame: June 2014-February 2014 ]
    Quality of Life measures will be measured via DLQI and Skindex29 patient surveys.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163746


Contacts
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Contact: Samreen Choudhry, MD 313-916-2151 schoudh5@hfhs.org

Locations
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United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Iltefat Hamzavi, MD         
Sub-Investigator: Samreen Choudhry, MD         
Sponsors and Collaborators
Henry Ford Health System

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Responsible Party: Iltefat Hamzavi, Senior Staff Physician, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT02163746     History of Changes
Other Study ID Numbers: 8606
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014
Keywords provided by Iltefat Hamzavi, Henry Ford Health System:
Hidradenitis suppurativa
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration