NCT03238469

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

June 25, 2018

Status Verified

June 1, 2018

Enrollment Period

7 months

First QC Date

July 31, 2017

Last Update Submit

June 21, 2018

Conditions

Hidradenitis SuppurativaAcne Inversa

Keywords

Microwave AblationHair FollicleSweat gland

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (6)

  • Hidradenitis Suppurativa Clinical Response (HiSCR30)

    6 months

  • Patient-reported number of HS flares

    6 months

  • Average number of hair containing follicles

    6 months

  • Extent of sweat production

    6 months

  • Patient-reported pain and pruritus

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Microwave ablation

EXPERIMENTAL

One-sided single microwave ablation (MWA) treatment in one axillary region with a miraDry device.

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.

Interventions

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.

Microwave ablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus University Medical Center

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Study Officials

  • Errol Prens, MD, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized intra-patient controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 3, 2017

Study Start

September 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

June 25, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

metc@erasmusmc.nl

Locations

NL(1)