Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis
Completed · Phase 3 · Has a placebo group
Conditions studied: Plaque Psoriasis
In brief
To compare the safety and efficacy of Padagis' product to an FDA approved product for the treatment of plaque psoriasis
Key facts
- Study ID
- NCT05763082
- Run by
- Padagis LLC
- People needed
- 414
- Starts
- 2023-02-07
- Expected to finish
- 2023-08-08
- Last updated by the study team
- 2024-08-12
Who can join
Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- DS Research — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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