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
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Condition or disease | Intervention/treatment | Phase |
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Hidradenitis Suppurativa Acne Inversa | Device: Microwave ablation | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Microwave ablation
One-sided single microwave ablation (MWA) treatment in one axillary region with a miraDry device.
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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.
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- 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
- 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
- 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.
- Average number of hair containing follicles [ Time Frame: 6 months ]Dermatoscopy of three fields per axilla
- Extent of sweat production [ Time Frame: 6 months ]Starch-Iodine test per axillary region
- Patient-reported pain and pruritus [ Time Frame: 6 months ]Numerical rating scale (NRS) to assess pain and itch per axillary region
- Incidence of (treatment-emergent) adverse events [ Time Frame: 6 months ]Safety and tolerability of the treatment

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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 |
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.

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
Netherlands | |
Erasmus University Medical Center | |
Rotterdam, Netherlands |
Principal Investigator: | Errol Prens, MD, PhD | Professor |
Responsible Party: | M.B.A. van Doorn, MD, PhD, Erasmus Medical Center |
ClinicalTrials.gov Identifier: | NCT03238469 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Microwave Ablation Hair Follicle Sweat gland |
Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial |
Bacterial Infections Skin Diseases, Infectious Infection Suppuration |