Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

• roflumilast cream 0.3% (Drug): test product
• Zoryve (Drug): Reference Listed Drug product
• Placebo (Drug): placebo

Primary outcomes

• Investigator's Global Assessment (IGA) [Day 1 to Day 56]: percentage of subjects at Day 56 who achieve Treatment Success, which is defined as an IGA score of None (0) or Minimal (1) with a 2-grade improvement from Day 1

Sex: All, ages: 12 Years to 75 Years

Inclusion Criteria:

1. Signed IRB approved written informed consent/assent
2. 12 to 75 years of age, inclusive.
3. Subjects must have a clinical diagnosis of stable symptomatic plaque psoriasis.
4. Baseline Investigator's Global Assessment Score of 3 (moderate).
5. Subjects must have a Body Surface Area (BSA) between 2% to 20%
6. 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.

Exclusion Criteria:

1. Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.
2. Current diagnosis of unstable forms of psoriasis in the treatment area.
3. History of unresponsiveness to topical treatment for psoriasis
4. Presence of any other skin condition that, in the Investigator's opinion, might interfere with psoriasis diagnosis and/or evaluations
5. 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
6. 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
7. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
8. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study

Participant flow

Outcome results

• Investigator's Global Assessment (IGA) (Primary), Count of participants, Participants: Padagis Active Product 78; Reference Product 79; Padagis Placebo Product 22

Adverse events

Time frame: Day 1 to 56

• Study Protocol (PDF, 2022-11-30)
• Statistical Analysis Plan (PDF, 2022-11-30)