WAVE: Microwave Ablation in Mild Axillary Hidradenitis Suppurativa

Sponsor

M.B.A. van Doorn (Other)

Overall Status

Terminated

CT.gov ID

NCT03238469

Collaborator

Erasmus Medical Center (Other)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hidradenitis Suppurativa Acne Inversa	Device: Microwave ablation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized intra-patient controlled trial.Randomized intra-patient controlled trial.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2017

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Hidradenitis Suppurativa Clinical Response (HiSCR50) [6 months]
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) [6 months]
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 [6 months]
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 [6 months]
Dermatoscopy of three fields per axilla
Extent of sweat production [6 months]
Starch-Iodine test per axillary region
Patient-reported pain and pruritus [6 months]
Numerical rating scale (NRS) to assess pain and itch per axillary region
Incidence of (treatment-emergent) adverse events [6 months]
Safety and tolerability of the treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erasmus University Medical Center	Rotterdam		Netherlands

Sponsors and Collaborators

M.B.A. van Doorn
Erasmus Medical Center

Investigators

Principal Investigator: Errol Prens, MD, PhD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

M.B.A. van Doorn, MD, PhD, Erasmus Medical Center

ClinicalTrials.gov Identifier:

NCT03238469

Other Study ID Numbers:

WAVE trial

First Posted:

Aug 3, 2017

Last Update Posted:

Jun 25, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by M.B.A. van Doorn, MD, PhD, Erasmus Medical Center

Microwave Ablation

Hair Follicle

Sweat gland

Additional relevant MeSH terms:

Hidradenitis Suppurativa

Hidradenitis

Study Results

No Results Posted as of Jun 25, 2018