Microwave Ablation in Mild Axillary Hidradenitis Suppurativa

NCT ID: NCT03238469

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-04-01

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.

Conditions

Hidradenitis Suppurativa; Acne Inversa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Microwave ablation

One-sided single microwave ablation (MWA) treatment in one axillary region with a miraDry device.

Group Type: EXPERIMENTAL

Microwave ablation

Intervention Type: DEVICE

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 microwave ablation

Lesion intervention in the non-MWA treated contralateral axilla consists of once daily topical clindamycin 1% lotion.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

M.B.A. van Doorn

OTHER

Sponsor Role: lead

Responsible Party

M.B.A. van Doorn

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Errol Prens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Erasmus University Medical Center

Rotterdam, , Netherlands

Countries

Netherlands

Other Identifiers

WAVE trial

Identifier Type: -

Identifier Source: org_study_id