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
|Condition or disease||Intervention/treatment||Phase|
|Hidradenitis Suppurativa||Procedure: CO2 (carbon dioxide) laser Procedure: Surgical Deroofing||Not Applicable|
- 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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Quality of Life Measures [ Time Frame: June 2014-February 2014 ]Quality of Life measures will be measured via DLQI and Skindex29 patient surveys.
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
|Contact: Samreen Choudhry, MDemail@example.com|
|United States, Michigan|
|Henry Ford Health System||Recruiting|
|Detroit, Michigan, United States, 48202|
|Principal Investigator: Iltefat Hamzavi, MD|
|Sub-Investigator: Samreen Choudhry, MD|