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Microwave Ablation in Mild Axillary Hidradenitis Suppurativa (WAVE)

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ClinicalTrials.gov Identifier: NCT03238469
Recruitment Status : Terminated (Negative clinical outcomes)
First Posted : August 3, 2017
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
Erasmus Medical Center
Information provided by (Responsible Party):
M.B.A. van Doorn, Erasmus Medical Center

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : September 1, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Hidradenitis Suppurativa Clinical Response (HiSCR50) [ Time Frame: 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 :
  1. Hidradenitis Suppurativa Clinical Response (HiSCR30) [ Time Frame: 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

  2. Patient-reported number of HS flares [ Time Frame: 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.

  3. Average number of hair containing follicles [ Time Frame: 6 months ]
    Dermatoscopy of three fields per axilla

  4. Extent of sweat production [ Time Frame: 6 months ]
    Starch-Iodine test per axillary region

  5. Patient-reported pain and pruritus [ Time Frame: 6 months ]
    Numerical rating scale (NRS) to assess pain and itch per axillary region

  6. Incidence of (treatment-emergent) adverse events [ Time Frame: 6 months ]
    Safety and tolerability of the treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238469


Locations
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Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
Sponsors and Collaborators
M.B.A. van Doorn
Erasmus Medical Center
Investigators
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Principal Investigator: Errol Prens, MD, PhD Professor

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Responsible Party: M.B.A. van Doorn, MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03238469     History of Changes
Other Study ID Numbers: WAVE trial
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: metc@erasmusmc.nl

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by M.B.A. van Doorn, Erasmus Medical Center:
Microwave Ablation
Hair Follicle
Sweat gland
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration