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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT03282994
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects \> 18 years of age.
2. Subject has benign superficial lesion(s) associated with common skin conditions amenable to cryosurgical treatment including, for example, psoriasis, acne, rosacea, and sebaceous hyperplasia.
3. Subject is willing to have up to 40 test sites treated.
4. Subject has read and signed a written informed consent form.
Exclusion Criteria:
1. Physician prescribed procedures in the area of intended treatment in the previous 6 months (e.g., photodynamic therapy, intense pulsed light therapy, laser surgery).
2. Dermatological conditions (e.g. vitiligo, open wounds, infection, pre-cancerous or malignant lesions) in the location of the treatment sites that would, in the professional opinion of the investigator, potentially pose an increased risk to the subject.
3. History of melanoma.
4. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease).
5. History of abnormal wound healing or abnormal scarring
6. Inability or unwillingness to comply with the study requirements.
7. Subject is pregnant or planning to become pregnant while enrolled in the study.
8. Subject is lactating.
9. Current enrollment in a clinical study of any other unapproved investigational drug or device.
10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an increased or unacceptable risk to the subject.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03282994
Study Brief:
Protocol Section:
NCT03282994