Phase
Condition
Psoriasis And Psoriatic Disorders
Rash
Rosacea
Treatment
Cetaphil
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult subjects aged 18 years and above
Females or males
Any Fitzpatrick skin types I-VI, with effort to include n = 2 for each category
Any races, with effort to include minimum 10% minority (n = 4) such as AmericanIndian or Alaska Native, Eastern/Southeastern Asian, South Asians, Black or AfricanAmerican, Native Hawaiian or Other Pacific Islander.
Any ethnicities, with effort to include minimum 10% (n = 4) of Hispanic, Latino, orSpanish origin
Having active target lesion plaques, with minimum area of 2 cm x 2 cm
Having mild-to-severe plaque psoriasis with at least 3% Body Surface Area (BSA) andcumulative Target Lesion Severity Score (TLSS) ≥ 6.
Currently on or starting a plaque psoriasis prescription treatment such asbiologics, oral or topical therapy for psoriasis, or UV therapy.
Subject in general good health
Subject willing to stop using current topical skincare products during the durationof the study.
Subject willing to replace current skincare products with study products for theduration of the study.
For female subjects of childbearing potential, she must not be pregnant,breastfeeding or planning pregnancy during the course of the study. Subjects must bewilling to take a urine pregnancy test (UPT) at Baseline visit. (Females ofnon-childbearing potential, e.g., post-menopausal (absence of menstrual bleeding for 1 year without any other medical reason), hysterectomy, or bilateral ovariectomy,are not required to have a UPT.)
Ability of giving consent for participation in the study
Willing to sign a photography release, with minimum 80% of total study panel
Agreement to adhere to the procedures and requirements of the study and to report tothe site on the day(s) and at the time(s) scheduled for the assessments
Exclusion
Exclusion Criteria:
Pregnant, breastfeeding, or planning pregnancy during the course of the study.
Subjects with any known allergies or hypersensitivity to any cosmetics, personalcare products, and/or fragrances.
History of cancer within the past 5 years
History or presence of any skin condition/disease, besides plaque psoriasis, thatmight interfere with the diagnosis or evaluation of study parameters at thediscretion of the investigator.
Planning on having surgeries and/or invasive medical procedures during the course ofthe study
Treatment with chemotherapy, immunosuppressive agents, prescription corticosteroidsfor psoriasis, immunomodulatory therapy (e.g., monoclonal antibodies or antiviraltreatment for human immunodeficiency virus or hepatitis C)
History or presence of any medical condition that, in the opinion of theInvestigator, would make the subject unsuitable for inclusion (e.g., a chronic,relapsing, or hereditary disease that may interfere the outcome of the study).
Other condition preventing the subject from entering the study in the Investigator'sopinion, (e.g., subjects failing baseline assessments, subjects not likely to avoidother treatments in the treated areas, subjects anticipated to be unavailable orincapable of understanding the study assessments or having unrealistic expectationsof the treatment result).
Study site personnel, close relatives of the study site personnel (e.g., parents,children, siblings, or spouse), or employees and close relatives of employees at theSponsor company.
Participation in any interventional clinical study within 30 days of screening orplanning to participate in another interventional clinical research study whileenrolled in this trial.
Study Design
Study Description
Connect with a study center
Southeast Dermatology Specialists, LLC
Columbus, Georgia 31904
United StatesSite Not Available
Southeast Dermatology Specialists, LLC
Douglasville, Georgia 30135
United StatesSite Not Available
Dermatology Consulting Services
High Point, North Carolina 27262
United StatesSite Not Available
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