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 @ 4:53 PM
Ignite Modification Date:
2025-12-24 @ 4:53 PM
NCT ID:
NCT04541550
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Can understand the nature of the procedure, and provide, or have a legal representative provide, a written informed consent.
* Clinically diagnosed with Hidradenitis Suppurativa characterized as Hurley Score, Stage II or Stage III.
* History of standard-of-care supportive treatment failure with corticosteroids and/or antibiotics within 30 days before the baseline visit.
* Must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the baseline visit.
* No prior history of a biologic product or Humira for the treatment of Hidradenitis Suppurativa.
Exclusion Criteria:
* Intolerance or unwillingness to participate in all procedure(s) or medication(s) required of this protocol.
* Diagnosis or reported history of any of the folding conditions:
1. Uncontrolled Diabetes Mellitus (HbA1c ≥9);
2. Severe Morbid Obesity (BMI≥40);
3. Chronic heart, renal, or hepatic disease;
4. Neurodegenerative debilitating conditions, and
5. Cancer.
* The participant is currently receiving or has received within 3 months before enrollment, medications or treatments that are known to affect the wound healing process, including but not limited to: chronic systemic steroid intake, history of recent changes in the participant's tissue integrity (i.e., thin, fragile skin with multiple hematomas or previous lacerations), current use of immune-suppressive drugs, radiation therapy, immunomodulating medications, and chemotherapy.
* The participant has received HS micronized amnion therapy in the last 90 days.
* Systolic blood pressure greater than 190 or less than 90 mmHg.
* Diastolic blood pressure greater than 105 or less than 50 mmHg.
* Early, symptomatic autonomic dysfunction.
* Abuse of prescription drugs, illegal substances, and/or alcohol.
* Females who are pregnant, nursing, or of childbearing potential and not using a reliable birth control method (such as, female use of a diaphragm, intrauterine device (IUD), or contraceptive sponge or gels, in addition to male use of a condom) or the female should be using prescribed "birth control" pills, injections, or implants. or who intend to become pregnant during their participation in the study.
* Clinically significant abnormal laboratory values at the time of the screening or baseline visit.
* Exposure to the investigational product within 3 months prior to enrollment or anticipate participation in any other investigational drug study or other interventional studies while enrolled in the study.
* In the opinion of the Principal Investigator, the participant should not be enrolled in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04541550
Study Brief:
Protocol Section:
NCT04541550