Microwave Ablation in Mild Axillary Hidradenitis Suppurativa (WAVE)

Long-term Efficacy and Safety of Microwave Ablation in the Treatment of Mild Axillary Hidradenitis Suppurativa

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.

Study Overview

• Status: Terminated
• Conditions: Hidradenitis Suppurativa; Acne Inversa
• Intervention / Treatment: Device: Microwave ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Erasmus University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microwave ablation; One-sided single microwave ablation (MWA) treatment in one axillary region with a miraDry device.	Device: Microwave ablation; 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.
No Intervention: No microwave ablation; Lesion intervention in the non-MWA treated contralateral axilla consists of once daily topical clindamycin 1% lotion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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.	6 months
Average number of hair containing follicles	Dermatoscopy of three fields per axilla	6 months
Extent of sweat production	Starch-Iodine test per axillary region	6 months
Patient-reported pain and pruritus	Numerical rating scale (NRS) to assess pain and itch per axillary region	6 months
Incidence of (treatment-emergent) adverse events	Safety and tolerability of the treatment	6 months

Collaborators and Investigators

• Sponsor: M.B.A. van Doorn
• Collaborators: Erasmus Medical Center
• Investigators: Principal Investigator: Errol Prens, MD, PhD, Professor

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 21, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Microwave Ablation; Hair Follicle; Sweat gland
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: WAVE trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: metc@erasmusmc.nl

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes