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
|Condition or disease||Intervention/treatment||Phase|
|Hidradenitis Suppurativa Acne Inversa||Device: Microwave ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized intra-patient controlled trial.|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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
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
|Erasmus University Medical Center|
|Principal Investigator:||Errol Prens, MD, PhD||Professor|