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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT04720105
Eligibility Criteria:
Inclusion Criteria
* Subject is able to provide written, informed consent and comply with the study protocol.
* Subject is at least 18 years of age.
* Subject has a diagnosis of plaque-type palmar and/or plantar psoriasis.
* Patient has at least one psoriatic plaque outside of the palms and soles or psoriatic nail findings.
* Subject has a ppPGA ≥ 3 at screening/baseline visit.
* Subject is using adequate birth control during the study period as defined as follows:
1. Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR
2. Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
OR
3. Option 3: Abstinence from sex when it is a lifestyle choice, and not just a social circumstance.
Exclusion Criteria
* Subject is not able to provide written, informed consent and comply with the study protocol.
* Subject is less than 18 years of age.
* Subject has non-plaque type psoriasis on the hands and/or feet.
* Patient does not have any evidence of psoriasis elsewhere.
* Subject has concurrent cutaneous disease affecting the hands and/or feet that would interfere with assessments.
* Subject has a ppPGA \< 3 at screening/baseline visit.
* Subject refuses to discontinue concomitant prescription medications on hands and/or feet.
* Subject has used topical prescription treatments or received phototherapy treatment for psoriasis within 2 weeks of screening/baseline visit.
* Subject has used intralesional kenalog within 4 weeks of screening/baseline visit.
* Subject has taken oral treatments for psoriasis within 4 weeks of screening/baseline visit.
* Subject has received any treatment with biologic medications within 5 half-lives (if known) or 16 weeks prior to screening/baseline, whichever is longer.
* Subject refuses to use adequate birth control during the duration of the study period.
* Subject is currently pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04720105
Study Brief:
Protocol Section:
NCT04720105