Psoriasis Clinical Trial
Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis
To compare the safety and efficacy of Padagis' product to an FDA approved product for the treatment of plaque psoriasis
Signed IRB approved written informed consent/assent
12 to 75 years of age, inclusive.
Subjects must have a clinical diagnosis of stable symptomatic plaque psoriasis.
Baseline Investigator's Global Assessment Score of 3 (moderate).
Subjects must have a Body Surface Area (BSA) between 2% to 20%
Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.
Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.
Current diagnosis of unstable forms of psoriasis in the treatment area.
History of unresponsiveness to topical treatment for psoriasis
Presence of any other skin condition that, in the Investigator's opinion, might interfere with psoriasis diagnosis and/or evaluations
Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments
Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study
Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study
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There is 1 Location for this study
Louisville Kentucky, 40241, United States
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