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



Status:Recruiting
Conditions:Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:13 - Any
Updated:4/2/2016
Start Date:March 2014
Contact:Samreen Choudhry, MD
Email:schoudh5@hfhs.org
Phone:313-916-2151

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

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

- 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.

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
We found this trial at
1
site
Detroit, Michigan 48202
?
mi
from
Detroit, MI
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