Study to Compare Two Treatments for Axillary Hidradenitis... | NCT02163746

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

NCT02163746

Sponsor

Henry Ford Health System

Status

Completed

Last Update Posted

Mar 2, 2022Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Hidradenitis Suppurativa

Interventions

CO2 (carbon dioxide) laser
Surgical Deroofing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2015Actual

Primary Completion Date

Dec 20, 2015Actual

Completion Date

Jun 7, 2016Actual

First Submitted Date

Jun 12, 2014

First Submission Date that Met QC Criteria

Jun 13, 2014

First Posted Date

Jun 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2022

Last Update Posted Date

Mar 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CO2 (carbon dioxide) laser	Procedure		CO2 (carbon dioxide) laser
Surgical Deroofing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of Life Measures	Quality of Life measures will be measured via DLQI and Skindex29 patient surveys.	June 2014-February 2014

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D017192	Skin Diseases, Bacterial
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
D002245	Carbon Dioxide
D007834	Lasers

ID	Term
D017554	Carbon Compounds, Inorganic
D007287	Inorganic Chemicals
D005740	Gases
D010087	Oxides