Hidradenitis SuppurativaWAVENCT03238469
Microwave Ablation in Mild Axillary Hidradenitis Suppurativa
A study testing Microwave ablation in people with Hidradenitis Suppurativa and Acne Inversa, run by M.B.A. van Doorn at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hidradenitis Suppurativa, Acne Inversa
- What is being tested?
- Microwave ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2017to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Efficacy and Safety of Microwave Ablation in the Treatment of Mild Axillary Hidradenitis Suppurativa
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.
Read the 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.
- Conditions
- Hidradenitis Suppurativa, Acne Inversa
- Being tested
- Microwave ablation
- Keywords
- Microwave Ablation, Hair Follicle, Sweat gland
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Microwave ablation | Experimental | One-sided single microwave ablation (MWA) treatment in one axillary region with a miraDry device. Receives: Device: Microwave ablation |
| No microwave ablation | No intervention | Lesion intervention in the non-MWA treated contralateral axilla consists of once daily topical clindamycin 1% lotion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hidradenitis Suppurativa Clinical Response (HiSCR50)
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
Measured: 6 months
Secondary outcomes (6)
Hidradenitis Suppurativa Clinical Response (HiSCR30)
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
Measured: 6 months
Patient-reported number of HS flares
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.
Measured: 6 months
Average number of hair containing follicles
Dermatoscopy of three fields per axilla
Measured: 6 months
Extent of sweat production
Starch-Iodine test per axillary region
Measured: 6 months
Patient-reported pain and pruritus
Numerical rating scale (NRS) to assess pain and itch per axillary region
Measured: 6 months
Incidence of (treatment-emergent) adverse events
Safety and tolerability of the treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Sep 2017
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Why it stopped: Negative clinical outcomes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized intra-patient controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.B.A. van Doorn
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor-investigator, M.B.A. van Doorn, Erasmus Medical Center
- Investigators
- Errol Prens, MD, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238469
- Sponsor's protocol ID
- WAVE trial
- Acronym
- WAVE
- Status last verified
- Jun 2018
- First submitted
- 31 Jul 2017
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: metc@erasmusmc.nl
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy and Safety of Microwave Ablation in the Treatment of Mild Axillary Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT03238469
- Acronym / sponsor ID
- WAVE / WAVE trial
- Conditions
- Hidradenitis Suppurativa, Acne Inversa
- Keywords
- Microwave Ablation, Hair Follicle, Sweat gland
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Negative clinical outcomes
- Enrolment
- 9 participants (actual)
- Lead sponsor
- M.B.A. van DoornUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized intra-patient controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Microwave ablation | Experimental | Device: Microwave ablationOne-sided single microwave ablation (MWA) treatment in one axillary region with a miraDry device. |
| No microwave ablation | No intervention | –Lesion intervention in the non-MWA treated contralateral axilla consists of once daily topical clindamycin 1% lotion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave ablationA 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. | Device | Microwave ablation |
Primary outcome
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
6 secondary outcomes
Hidradenitis Suppurativa Clinical Response (HiSCR30)
Time frame: 6 months
Patient-reported number of HS flares
Time frame: 6 months
Average number of hair containing follicles
Time frame: 6 months
Extent of sweat production
Time frame: 6 months
Patient-reported pain and pruritus
Time frame: 6 months
Incidence of (treatment-emergent) adverse events
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Negative clinical outcomes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Individual participant dataSharing planned: No. metc@erasmusmc.nl
Related trials for Hidradenitis Suppurativa
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A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
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Acceptability of MBSR for People With HS
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Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
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ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Errol Prens, MD, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave ablation in people with Hidradenitis Suppurativa and Acne Inversa, run by M.B.A. van Doorn at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Negative clinical outcomes). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hidradenitis Suppurativa Clinical Response (HiSCR50) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.