Status:
TERMINATED
Microwave Ablation in Mild Axillary Hidradenitis Suppurativa
Lead Sponsor:
M.B.A. van Doorn
Collaborating Sponsors:
Erasmus Medical Center
Conditions:
Hidradenitis Suppurativa
Acne Inversa
Eligibility:
All Genders
18-80 years
Phase:
NA
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 thermoly...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03238469
Start Date
September 1 2017
End Date
April 1 2018
Last Update
June 25 2018
Active Locations (1)
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1
Erasmus University Medical Center
Rotterdam, Netherlands