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 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT03180866
Eligibility Criteria:
Inclusion Criteria:
1. Male or female of any race, greater than 18 years of age.
2. Verbal and written informed consent obtained from the subject.
3. Has a clinical diagnosis of plaque psoriasis at the Screening and Baseline visits.
4. Has an IGA score of 2 to 4 that is consistent between the Screening and Baseline visits.
5. TPA score of 5-12 and a score of at least 1 for each of the 3 different psoriasis signs and symptoms (erythema, plaque elevation, and scaling) at the baseline visits.
6. Has at least 2 plaques of at least 6cm by 3cm with TPA scores not differing from each other by a score of more than 1 that are at least 2 inches apart at the baseline visit.
7. Is in good general health as determined by the Investigator based on the subject's medical history.
8. Females of childbearing potential must have negative urine or blood pregnancy test results. Females of childbearing potential agree to use acceptable methods of contraception from the screening visit continuously until 30 days after end of treatment.
9. Subject agrees to use only the Sponsor provided cleanser and lotion during the study phase unless given permission by Investigator to use other topicals on non-target plaques.
10. Subject is willing and able to return for all study visits.
Exclusion Criteria:
1. Presence of psoriasis that was previously treated with prescription medications prior to the Screening visit and was non-responsive to treatment, as determined by the Investigator.
2. Presence of any concurrent skin condition that could interfere with the evaluation of the study device, as determined by the Investigator.
3. Female who is pregnant, nursing an infant, or planning a pregnancy during the Active Treatment Phase.
4. Treatment with any investigational drug or device within 2 weeks or 5 half-lives (whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial with an investigational drug or device.
5. History of melanoma.
6. Subject has any medical, social or psychological conditions that, in the opinion of the Investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
7. Subject has known allergy or adverse reaction to skin adhesives or hydrogels or coal tar.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03180866
Study Brief:
Protocol Section:
NCT03180866