Hidradenitis SuppurativaNCT02163746
Study to Compare Two Treatments for Axillary Hidradenitis Suppurativa: Carbon Dioxide Laser Versus Surgical Deroofing
A study testing CO2 (carbon dioxide) laser and Surgical Deroofing in people with Hidradenitis Suppurativa, run by Henry Ford Health System at 1 site in United States.
Trial summary
This study compares two well-known treatment options for Stage 2 hidradenitis suppurativa: carbon dioxide (CO2) laser excision versus surgical deroofing. Read more about this study
- Who is it for?
- Ages 13 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- CO2 (carbon dioxide) laser and Surgical Deroofing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2015to 7 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This study compares two well-known treatment options for Stage 2 hidradenitis suppurativa: carbon dioxide (CO2) laser excision versus surgical deroofing.
Read the 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:
- 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- CO2 (carbon dioxide) laser, Surgical Deroofing
- Keywords
- Hidradenitis suppurativa
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 (carbon dioxide) laserProcedure or surgery
Surgical DeroofingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| CO2 (carbon dioxide) laser | Active comparator | Patients randomized to this group will undergo CO2 laser excision of the sinus tracts in affected axilla Receives: Procedure: CO2 (carbon dioxide) laser |
| Surgical Deroofing | Active comparator | Patients randomized to this group will undergo surgical deroofing of the sinus tracts in affected axilla Receives: Procedure: Surgical Deroofing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Measures
Quality of Life measures will be measured via DLQI and Skindex29 patient surveys.
Measured: June 2014-February 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study start14 Jan 2015
- Primary completion20 Dec 2015
- Study completion7 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iltefat Hamzavi, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163746
- Sponsor's protocol ID
- 8606
- Status last verified
- Feb 2022
- First submitted
- 12 Jun 2014
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02163746
- Acronym / sponsor ID
- 8606
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis suppurativa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 14 Jan 2015 (actual)
- Primary completion
- 20 Dec 2015 (actual)
- Study completion
- 7 Jun 2016 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 (carbon dioxide) laser | Active comparator | Procedure: CO2 (carbon dioxide) laserPatients randomized to this group will undergo CO2 laser excision of the sinus tracts in affected axilla |
| Surgical Deroofing | Active comparator | Procedure: Surgical DeroofingPatients randomized to this group will undergo surgical deroofing of the sinus tracts in affected axilla |
Who may qualify
- Ages
- 13 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 (carbon dioxide) laser | Procedure or surgery | CO2 (carbon dioxide) laser |
| Surgical Deroofing | Procedure or surgery | Surgical Deroofing |
Primary outcome
Quality of Life Measures
Time frame: June 2014-February 2014
Quality of Life measures will be measured via DLQI and Skindex29 patient surveys.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 (carbon dioxide) laser and Surgical Deroofing in people with Hidradenitis Suppurativa, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Measures (time frame: June 2014-February 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.