Clinical trial NCT03238469: Microwave Ablation in Mild Axillary Hidradenitis Suppurativa
Official title: Long-term Efficacy and Safety of Microwave Ablation in the Treatment of Mild Axillary Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hidradenitis Suppurativa
Acne Inversa
Keywords: Microwave Ablation
Hair Follicle
Sweat gland
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2017-08-03
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized intra-patient controlled trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hidradenitis Suppurativa Clinical Response (HiSCR50)
timeFrame: 6 months
Secondary outcomes:
measure: Hidradenitis Suppurativa Clinical Response (HiSCR30)
timeFrame: 6 months
measure: Patient-reported number of HS flares
timeFrame: 6 months
measure: Average number of hair containing follicles
timeFrame: 6 months
measure: Extent of sweat production
timeFrame: 6 months
measure: Patient-reported pain and pruritus
timeFrame: 6 months
measure: Incidence of (treatment-emergent) adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
Study officials:
affiliation: Professor
name: Errol Prens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: