Microwave Ablation in Mild Axillary Hidradenitis Suppurativa (WAVE)
Primary Purpose
Hidradenitis Suppurativa, Acne Inversa
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Microwave ablation
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Microwave Ablation, Hair Follicle, Sweat gland
Eligibility Criteria
Inclusion Criteria:
- Adult (≥ 18 years of age) male or female patients with mild HS and able to participate, willing to give written informed consent and to comply with the study restrictions;
- Minimum of 3 AN-count located in each axilla;
- Maximum of 5 AN-count located in each axilla.
Exclusion Criteria:
- Patients with >1 abscesses or draining fistulas per axillary region;
- AN-count ≥ 5 in other regions than the axillary area;
- Any current and / or recurrent clinically significant skin condition in the treatment area other than HS;
- Surgical scars covering more than 25% of each individual axillary area;
- Open surgical wound(s) in the axillary areas prior to randomization;
- Use of anti-inflammatory or immunomodulatory medication (intralesional corticosteroids, oral antibiotics, biologics, prednisone) within 2 weeks prior to randomization;
- Contraindication for miraDry therapy;
- Heart pacemakers and other electronic device implants;
- Supplemental oxygen;
- Resistance to or history of intolerance of local anesthesia including lidocaine and epinephrine;
- Previous use of miraDry therapy or MWA in the axillary area;
- Previous use of successful laser or light therapy for hair removal in the axillary area;
- Use of botulinum toxin injections 6 months prior to randomization;
- Use of aluminiumhydroxychloride 1 month prior to randomization;
- Pregnant or lactating women at randomization.
Sites / Locations
- Erasmus University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Microwave ablation
No microwave ablation
Arm Description
One-sided single microwave ablation (MWA) treatment in one axillary region with a miraDry device.
Lesion intervention in the non-MWA treated contralateral axilla consists of once daily topical clindamycin 1% lotion.
Outcomes
Primary Outcome Measures
Hidradenitis Suppurativa Clinical Response (HiSCR50)
The proposed definition of 50% responders to treatment (HiSCR50 achievers) is: (i) at least a 50% reduction in ANs, (ii) no increase in the number of abscesses, and (iii) no increase in the number of draining fistulas from baseline
Secondary Outcome Measures
Hidradenitis Suppurativa Clinical Response (HiSCR30)
The proposed definition of 30% responders to treatment (HiSCR30 achievers) is: (i) at least a 30% reduction in ANs, (ii) no increase in the number of abscesses, and (iii) no increase in the number of draining fistulas from baseline
Patient-reported number of HS flares
The number of HS flares in the treated and untreated axillae. At baseline retrospective assessment on last month, and during follow-up prospective assessment using a diary where patients will report the number of acute boils per axilla.
Average number of hair containing follicles
Dermatoscopy of three fields per axilla
Extent of sweat production
Starch-Iodine test per axillary region
Patient-reported pain and pruritus
Numerical rating scale (NRS) to assess pain and itch per axillary region
Incidence of (treatment-emergent) adverse events
Safety and tolerability of the treatment
Full Information
NCT ID
NCT03238469
First Posted
July 31, 2017
Last Updated
June 21, 2018
Sponsor
M.B.A. van Doorn
Collaborators
Erasmus Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03238469
Brief Title
Microwave Ablation in Mild Axillary Hidradenitis Suppurativa
Acronym
WAVE
Official Title
Long-term Efficacy and Safety of Microwave Ablation in the Treatment of Mild Axillary Hidradenitis Suppurativa
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Negative clinical outcomes
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
M.B.A. van Doorn
Collaborators
Erasmus Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
With microwave ablation (MWA), using the heat generated from electromagnetic waves in the microwave energy spectrum, hair follicles and apocrine glands in the (hypo)dermis are ablated through thermolysis. MWA was recently approved for the treatment of axillary hyperhidrosis (miraDry) and removal of axillary hair (miraSmooth). By permanent removal of hairs and sweat glands, the investigators hypothesize a beneficial and long-term sustainable preventive effect of MWA in HS patients.
Detailed Description
Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease of the hair follicle, and is predominantly located in the axillary, inguinal and anogenital regions. Current treatment options for HS include systemic oral antibiotics, anti-TNFα, and surgery, which are used to treat the consequences rather than treating the primary pathogenesis of HS. With microwave ablation (MWA), using the heat generated from electromagnetic waves in the microwave energy spectrum, hair follicles, eccrine and apocrine glands in the (hypo)dermis are ablated through thermolysis. MWA was recently approved for the treatment of axillary hyperhidrosis (miraDry) and removal of axillary hair (miraSmooth). By permanent removal of hairs and sweat glands, the investigators hypothesize a beneficial and long-term sustainable preventive effect of MWA in HS patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa, Acne Inversa
Keywords
Microwave Ablation, Hair Follicle, Sweat gland
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized intra-patient controlled trial.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microwave ablation
Arm Type
Experimental
Arm Description
One-sided single microwave ablation (MWA) treatment in one axillary region with a miraDry device.
Arm Title
No microwave ablation
Arm Type
No Intervention
Arm Description
Lesion intervention in the non-MWA treated contralateral axilla consists of once daily topical clindamycin 1% lotion.
Intervention Type
Device
Intervention Name(s)
Microwave ablation
Intervention Description
A one-sided (either right or left axillary area) single MWA treatment using a miraDry system. The miraDry device has a microwave output frequency of 5.8 GHz and microwave energy level settings ranging from 1 to 5, corresponding with a delivery time in seconds between 2.40 sec and 3.00 sec. For this study standard 5 (i.e. 3.00 sec) is set as treatment setting.
Primary Outcome Measure Information:
Title
Hidradenitis Suppurativa Clinical Response (HiSCR50)
Description
The proposed definition of 50% responders to treatment (HiSCR50 achievers) is: (i) at least a 50% reduction in ANs, (ii) no increase in the number of abscesses, and (iii) no increase in the number of draining fistulas from baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hidradenitis Suppurativa Clinical Response (HiSCR30)
Description
The proposed definition of 30% responders to treatment (HiSCR30 achievers) is: (i) at least a 30% reduction in ANs, (ii) no increase in the number of abscesses, and (iii) no increase in the number of draining fistulas from baseline
Time Frame
6 months
Title
Patient-reported number of HS flares
Description
The number of HS flares in the treated and untreated axillae. At baseline retrospective assessment on last month, and during follow-up prospective assessment using a diary where patients will report the number of acute boils per axilla.
Time Frame
6 months
Title
Average number of hair containing follicles
Description
Dermatoscopy of three fields per axilla
Time Frame
6 months
Title
Extent of sweat production
Description
Starch-Iodine test per axillary region
Time Frame
6 months
Title
Patient-reported pain and pruritus
Description
Numerical rating scale (NRS) to assess pain and itch per axillary region
Time Frame
6 months
Title
Incidence of (treatment-emergent) adverse events
Description
Safety and tolerability of the treatment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (≥ 18 years of age) male or female patients with mild HS and able to participate, willing to give written informed consent and to comply with the study restrictions;
Minimum of 3 AN-count located in each axilla;
Maximum of 5 AN-count located in each axilla.
Exclusion Criteria:
Patients with >1 abscesses or draining fistulas per axillary region;
AN-count ≥ 5 in other regions than the axillary area;
Any current and / or recurrent clinically significant skin condition in the treatment area other than HS;
Surgical scars covering more than 25% of each individual axillary area;
Open surgical wound(s) in the axillary areas prior to randomization;
Use of anti-inflammatory or immunomodulatory medication (intralesional corticosteroids, oral antibiotics, biologics, prednisone) within 2 weeks prior to randomization;
Contraindication for miraDry therapy;
Heart pacemakers and other electronic device implants;
Supplemental oxygen;
Resistance to or history of intolerance of local anesthesia including lidocaine and epinephrine;
Previous use of miraDry therapy or MWA in the axillary area;
Previous use of successful laser or light therapy for hair removal in the axillary area;
Use of botulinum toxin injections 6 months prior to randomization;
Use of aluminiumhydroxychloride 1 month prior to randomization;
Pregnant or lactating women at randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Errol Prens, MD, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus University Medical Center
City
Rotterdam
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
metc@erasmusmc.nl
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Microwave Ablation in Mild Axillary Hidradenitis Suppurativa
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