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:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT07077902
Eligibility Criteria:
Inclusion Criteria:
* Must understand the risks and the benefits/purpose of the study and provide signed and dated informed consent.
* Must be 18 years at time of signing informed consent form.
* Willing to participate in all required evaluations and procedures in the study including the ability to apply topical medication without difficulty.
* Patients must have a diagnosis of HS based upon the clinical criteria of a history of more than or equal 5 typical lesions (erythematous papules, nodules, or abscesses) in flexural sites with a recurring nature over time.
* Patients must be candidate for topical therapy defined by active Hurley stage I or Hurley stage II/III with active disease after an adequate trial of systemic antibiotics/hormonal/immunomodulatory or biologic therapy.
* Patient is required to be on stable dose of concomitant therapy for at least 3 months before enrollment and throughout the study period.
* Females of childbearing potential must have a negative urine pregnancy test at baseline visit and be on adequate contraception throughout the study time.
Exclusion Criteria:
* Concomitant use of topical antibiotics, topical corticosteroids, resorcinol, benzoyl peroxide, vitamin D analogs, Hibiclens wash (except for emollients) within 1 week of enrollment.
* Increasing or changing dosing for concurrent therapy agents within 90 days before study day 0 and during the study period.
* History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major uncontrolled disease.
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
* Pregnant or breastfeeding.
* Prior major surgery or major life-threatening medical illness within 2 weeks.
* Active hepatitis B or C infection with detectible viral nucleic acid in the blood or known Human Immunodeficiency Virus (HIV) positivity.
* Patients with known active malignancy.
* Any severe systemic illness requiring Intravenous (IV) antibiotics within the two weeks prior to initiation of the study drug.
* Active substance abuse or a history of substance abuse within 6 months prior to screening.
* Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT07077902
Study Brief:
Protocol Section:
NCT07077902