Microwave Ablation in Mild Axillary Hidradenitis Suppurativa (WAVE)

M.B.A. van Doorn

Status

Terminated

Conditions

Acne Inversa

Hidradenitis Suppurativa

Treatments

Device: Microwave ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT03238469

WAVE trial

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.