Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT03238469
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03238469
Study Brief:
Protocol Section:
NCT03238469