Evaluating the Efficacy and Tolerability of Application of Metaderm Product for the Treatment of Psoriasis

Completed · Phase 4 · Has a placebo group

Conditions studied: Psoriasis

In brief

Psoriasis vulgaris is a common inflammatory condition of the skin that results in well-demarcated, scaly, erythematous, itchy plaques. In the United States, psoriasis remains a common, immune-mediated disease, affecting 7.4 million adults. Often topical prescription medications are used as first line treatment for moderate psoriasis. Some topical medications have side effects and risk with long time use, thus not ideal for extensive and indefinite amount of time. Conversely, over- the-counter emollient treatments are readily available, safe and potentially efficacious. This study is design to test the safety and efficacy of topical application of the Metaderm product cream. The Metaderm cream is non-prescription, natural product.

Key facts

Study ID

NCT03597620

Run by

University of Alabama at Birmingham

People needed

11

Starts

2018-11-07

Expected to finish

2022-12-13

Last updated by the study team

2023-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• The presence of any of the following will exclude a subject from enrollment:
• Other than disease under study, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
• Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
• Prior history of suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
• Pregnant or breast feeding.
• Active substance abuse or a history of substance abuse within 6 months prior to Screening.
• Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
• Prior treatment with the investigational product
• Unable to comply with the protocol (as defined by the Investigator; i.e. drug or alcohol abuse or history of noncompliance)
• Any other dermatologic conditions that prohibit or confound the ability of the investigator to interpret skin and/or nail exam findings.
• Patients who will be unable to avoid the use of systemic steroids, excluding intranasal or inhaled steroids that will be permitted, for the duration of the trial

Where it is running

• Dermatology at the Whitaker Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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